[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"prostate-cancer-metastatic\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:prostate-cancer-metastatic":31},{"pageToken":4,"total":5,"offset":6,"count":7,"results":8},null,32,0,25,[9,51,77,101,133,157,182,223,243,275,295,315,343,371,408,433,456,482,504,530,557,577,606,629,659],{"id":10,"slug":11,"hasResults":12,"nctId":13,"briefTitle":14,"officialTitle":15,"acronym":4,"eligibilityCriteria":16,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":25,"conditions":26,"keywords":32,"overallStatus":38,"whyStopped":4,"lastUpdateSubmitDate":39,"lastUpdatePostDateStruct":40,"startDateStruct":43,"completionDateStruct":45,"leadSponsor":47,"locationsCount":50},"100640146","phase-2-prostate-specific-membrane-antigen-psma-imaging-for-detection-of-residual-and-metastatic-prostate-cancer-100640146",false,"NCT07593079","Prostate Specific Membrane Antigen (PSMA) Imaging for Detection of Residual and Metastatic Prostate Cancer","Optimizing PSMA Imaging for Enhanced Detection of Residual and Metastatic Prostate Cancer in Low PSA Recurrence (OPERA) Study","Inclusion Criteria:\n\n* Histologically or cytologically confirmed biochemically recurrent prostate cancer, with original diagnosis no more than 2 years from date of consent.\n* Intermediate unfavorable or high-risk prostate cancer.\n* All patients under consideration for radiation therapy, either at the time of first recurrence or in salvage radiation therapy will be included.\n* Patients who have started bicalutamide up to a maximum of 3 days prior to randomization will be allowed to be on protocol. Otherwise, a washout period of at least 42 days will be required.\n* Biological males, at least 18 years of age.\n* Prostate specific antigen (PSA) \\\u003C 1.0 ng\u002FmL.\n* Agreement to adhere to Lifestyle Considerations throughout study duration\n* Ability to understand and willingness to sign an IRB approved written informed consent document.\n\nExclusion Criteria:\n\n* Patients currently on androgen deprivation therapy (ADTs).\n* Currently receiving any other investigational agents.\n* A history of allergic reactions attributed to compounds of similar chemical or biologic composition to POSLUMA, furosemide, bicalutamide, or other agents used in the study.","MALE","18 Years",{"count":20,"type":21},20,"ESTIMATED","INTERVENTIONAL",[24],"PHASE2","This is a randomized, open-label, pilot study assessing the impact of a short course of bicalutamide on PSMA expression in patients with prostate cancer belonging to the intermediate unfavorable or high risk group, who have low levels of PSA. Adult patients with biochemically recurrent prostate cancer (BCR PCa) who have a PSA of less than 1.0 ng\u002FmL and who have undergone complete prostatectomy and\u002For will be undergoing radiotherapy, in combination with standard of care bicalutamide, will be recruited to this study. Patients will be randomized in a 1:1 ratio into Group A (baseline PSMA PET\u002FCT only with bicalutamide standard of care) or Group B (baseline PSMA PET\u002FCT and an additional PSMA PET\u002FCT after 2 weeks of bicalutamide).",[27,28,29,30,31],"Prostate Cancer","Recurrent Prostate Cancer","Metastatic Prostate Cancer","Prostate Cancer Recurrent","Prostate Cancer Metastatic",[33,34,35,36,37],"Prostate cancer","Low PSA","PSMA PET","BCR","Bicalutamide","NOT_YET_RECRUITING","2026-06-29",{"date":41,"type":42},"2026-07-01","ACTUAL",{"date":44,"type":21},"2026-07-31",{"date":46,"type":21},"2027-10-31",{"name":48,"class":49},"Washington University School of Medicine","OTHER",1,{"id":52,"slug":53,"hasResults":12,"nctId":54,"briefTitle":55,"officialTitle":56,"acronym":4,"eligibilityCriteria":57,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":58,"targetDuration":4,"studyType":22,"phases":60,"briefSummary":62,"conditions":63,"keywords":64,"overallStatus":67,"whyStopped":4,"lastUpdateSubmitDate":68,"lastUpdatePostDateStruct":69,"startDateStruct":71,"completionDateStruct":73,"leadSponsor":75,"locationsCount":50},"100579640","7-days-water-only-fasting-or-ketone-supplementation-trial-in-prostate-cancer-100579640","NCT06826924","7-Days Water-Only Fasting or Ketone Supplementation Trial in Prostate Cancer","A Study of 7-days Water-only Fasting or Ketone Supplementation in Patients With Prostate Cancer","Inclusion criteria:\n\n* Eastern Cooperative Oncology Group (ECOG) Performance Status 0 or 1\n* Age ≥18 years\n* Diagnosis of adenocarcinoma of the prostate\n* If a soft tissue metastasis amenable to biopsy is present, then the participant must agree to biopsies.\n* If the participant has local prostate cancer, then the participant must agree to prostate biopsy or radical prostatectomy on days 8, 9, or 10. -. Prostate-specific antigen (PSA) is not currently declining, as determined by most recent 2 measurements taken at least 1 week apart in previous 2 months.\n* BMI between 20 and 35 kg\u002Fm2\n* Prior treatment with any prostate cancer therapy is permitted if \\>2 weeks from last dose. Patients are not required to have received prior treatment for prostate cancer.\n* Prior treatment with steroids is permitted if \\>2 weeks from last dose. Patients who cannot be weaned off steroids are not eligible.\n* Acceptable liver function:\n\n  1. Bilirubin \\\u003C 2.5 times institutional upper limit of normal (ULN)\n  2. Aspartate transaminase (AST) (SGOT) and Alanine transaminase (ALT) (SGPT) \\\u003C 2.5 times ULN\n* Acceptable renal function: glomerular filtration rate (GFR) of 50 mL\u002Fmin\u002F1.73 m2 or higher. GFR will be estimated by the 2021 chronic kidney disease epidemiology (CKD-EPI) creatinine equation1 using the online calculator found on UpToDate.\n* Acceptable hematologic status:\n\n  1. Absolute neutrophil count (ANC) ≥ 1500 cells\u002Fmm3 (1.5 ×109\u002FL)\n  2. Platelet count ≥ 100,000 platelet\u002Fmm3 (100 ×109\u002FL)\n  3. Hemoglobin ≥ 8 g\u002FdL.\n* Acceptable electrolyte and acid\u002Fbase status:\n\n  1. Sodium 135-148 millimoles (mM)\n  2. Potassium 3.5-5.1mM\n  3. Carbon Dioxide 21-31mM\n  4. Phosphorus 2.7-4.5mM\n  5. Magnesium ≥1.6mM\n  6. Lactate ≤2mM\n* Ability to understand and willingness to sign a written informed consent document\n\nExclusion criteria:\n\n* ECOG Performance status ≥2\n* Unintentional weight loss greater than or equal to 5% in previous 3 months\n* Diabetes mellitus, defined as HbA1c ≥6.5% or use of medications for diabetes\n* Active uncontrolled infection. Patients with a history of HIV\u002FAIDS may be eligible if CD4+ T cell counts are ≥ 350 cell\u002Ful, the patients have had no opportunistic infection within the past 12 months, they have been on established antiretroviral therapy (ART) for at least four weeks, and the HIV viral load is less than 400 copies\u002Fml prior to enrollment. Patients with a history of hepatitis C virus (HCV) infection are eligible if the patients have completed curative antiviral treatment and the HCV viral load is below the limit of quantification.\n* Use of immunosuppressive medications including steroids\n* Use of diuretics or beta blockers\n* History of cardiac arrythmia, myocardial infarction, valvular heart disease, or pulmonary hypertension\n* Abnormal screening EKG\n* Daily alcohol consumption\n* Any condition or mental impairment that may compromise the ability to give informed consent, patient's safety or compliance with study requirements as determined by the investigator",{"count":59,"type":21},40,[61],"NA","Activating the immune system to kill cancer cells is a promising therapeutic strategy for some patients with cancer. Unfortunately, current immune-targeting treatments do not work for patients with prostate cancer. In animal models of cancer, fasting can reprogram the body's metabolism and immune cell function to help immune cells kill cancer cells likely by increasing ketosis. The purpose of this study is to determine whether 7 days of water-only fasting or a ketogenic very low-calorie diet or ketone supplementation is safe and feasible for patients with prostate cancer. This will help the investigators develop future studies to test whether incorporating periods of fasting or very low calorie diets or a ketone supplement into treatment plans for prostate cancer can improve outcomes from this disease.",[27,31],[65,66],"fasting","ketone supplementation","RECRUITING","2026-06-25",{"date":70,"type":42},"2026-06-30",{"date":72,"type":42},"2025-06-03",{"date":74,"type":21},"2027-06-03",{"name":76,"class":49},"Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins",{"id":78,"slug":79,"hasResults":12,"nctId":80,"briefTitle":81,"officialTitle":82,"acronym":4,"eligibilityCriteria":83,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":84,"targetDuration":4,"studyType":86,"phases":4,"briefSummary":87,"conditions":88,"keywords":89,"overallStatus":67,"whyStopped":4,"lastUpdateSubmitDate":92,"lastUpdatePostDateStruct":93,"startDateStruct":95,"completionDateStruct":97,"leadSponsor":99,"locationsCount":50},"100457909","ftt-petct-in-metastatic-prostate-cancer-100457909","NCT05242744","FTT PET\u002FCT in Metastatic Prostate Cancer","Evaluating in Vivo PARP-1 Expression With 18F-FluorThanatrace Positron Emission Tomography (PET\u002FCT) in Patients With Metastatic Prostate Cancer","Inclusion Criteria:\n\n1. Participants will be ≥ 18 years of age\n2. Histologically proven prostate carcinoma\n3. Clinical evidence of metastatic disease with at least one lesion identified on standard of care imaging (CT, MRI, Bone Scan, FDG or other PET\u002FCT, Ultrasound)\n4. Considered a candidate for new therapy or change in therapy with PARP inhibitor therapy and\u002For androgen deprivation therapy (ADT) and\u002For chemotherapy with or without additional agents, either on a clinical trial or as part of clinical care.\n5. Participants must be informed of the investigational nature of this study and be willing to provide written informed consent and participate in this study in accordance with institutional and federal guidelines prior to study-specific procedures.\n\nExclusion Criteria:\n\n1. Inability to tolerate imaging procedures in the opinion of an investigator or treating physician\n2. Any current medical condition, illness, or disorder as assessed by medical record review and\u002For self-reported that is considered by a physician investigator to be a condition that could compromise participant safety or successful participation in the study",{"count":85,"type":21},30,"OBSERVATIONAL","Up to 30 men with metastatic prostate cancer will undergo up to 2 FTT PET\u002FCT scans to look at PARP activity in sites of known cancer. Subjects will undergo a baseline scan prior to starting new therapy and a second, optional, post-therapy scan 1-21 days after the start of treatment. Tissue from a clinical or research biopsy will be compared to imaging measures, if available.",[31],[90,91],"PET\u002FCT","PARP inhibitor","2026-06-24",{"date":94,"type":42},"2026-06-26",{"date":96,"type":42},"2023-03-01",{"date":98,"type":21},"2027-07",{"name":100,"class":49},"Abramson Cancer Center at Penn Medicine",{"id":102,"slug":103,"hasResults":12,"nctId":104,"briefTitle":105,"officialTitle":106,"acronym":107,"eligibilityCriteria":108,"healthyVolunteers":12,"sex":109,"minAge":18,"maxAge":4,"enrollmentInfo":110,"targetDuration":4,"studyType":22,"phases":112,"briefSummary":114,"conditions":115,"keywords":118,"overallStatus":67,"whyStopped":4,"lastUpdateSubmitDate":123,"lastUpdatePostDateStruct":124,"startDateStruct":126,"completionDateStruct":128,"leadSponsor":130,"locationsCount":50},"100612598","phase-1-a-fih-phase-iiia-trial-assessing-feasibility-of-administrations-of-til-based-immunotherapy-in-patients-with-metastatic-crc-and-pc-100612598","NCT07255664","A FIH, Phase I\u002FIIa, Trial Assessing Feasibility of Administrations of TIL-based Immunotherapy in Patients With Metastatic CRC and PC","A FIH, Phase I\u002FIIa, Open-label Trial Assessing Safety, Tolerability, and Feasibility of Repeated Administrations of a Novel Autologous TIL-based Immunotherapy in Patients With Metastatic Colorectal or Prostate Cancer","ProbeTILity","Inclusion Criteria:\n\n* Patient (female or male) has signed informed consent according to ICH\u002FGCP and national\u002Flocal regulations prior to any trial-specific procedure.\n* Patient is 18 years or older at the time of signing the informed consent form.\n* Patient must live in an area where a hospital for care can be reached within a maximum of 50 km.\n* Patient has histological or cytological confirmation of:\n\n  * colorectal cancer, which is stage IV (any T \u002F any N \u002F M1), not amenable to curative surgery, OR\n  * prostate cancer, which is stage III locally advanced, not amenable to curative surgery (T3-4 \u002F N0 \u002F M0 or any T \u002F N1 \u002F M0), or stage IV metastatic (any T \u002F any N \u002F M1)\n* Patient has received all lines of therapy that\n\n  * are considered SOC for the patient's indication according to applicable European\u002Fnational professional society medical guidelines and local medical practice at time of enrollment\n  * are available via the national health insurance system and the patient is considered eligible for but led to insufficient response or were medically not justified or refused by the patient.\n* Patient has confirmed disease progression by radiologic imaging from the previous line of therapy.\n* Patient has sufficient amount of previously not irradiated tumor tissue in adequate quality for TIL harvest and expansion, i.e., either:\n\n  * Primary or metastatic lesion has been selected for surgery (e.g., to reduce tumor burden, pain relief), Or\n  * Patient has consented to surgery for the purpose of tissue harvesting for TIL expansion and is considered suitable to undergo surgery for this purpose. Note: Patients with a non-justifiable anesthesiologic and\u002For surgical risk, as determined by the investigator, should be excluded\n* Patient has a least one measurable or assessable lesion according to RECIST 1.1 remaining after tumor resection for CC-38 manufacturing has been performed.\n* Patient has ECOG performance status of 0 or 1.\n* Patient has a minimum life expectancy of 6 months in the opinion of the investigator from the time of consent date.\n* Patient has adequate bone marrow, hepatic and renal function in the opinion of the investigator:\n\n  1. Hemoglobin ≥ 9.0 g\u002FdL,\n  2. Absolute neutrophil count (ANC) ≥ 1.0 x 109 \u002FL,\n  3. Platelets ≥ 80 x 109 \u002FL,\n  4. Calculated creatinine clearance ≥ 50 mL\u002Fmin (Cockcroft-Gault formula),\n  5. Serum bilirubin ≤ 1.5 x ULN (or ≤ 2.5 x ULN in the presence of documented Gilbert's Syndrome \\[unconjugated hyperbilirubinemia\\] or liver metastases),\n  6. AST\u002F ALT and alkaline phosphatase ≤ 2.5 x ULN (or ≤5 times ULN in the presence of bone and\u002For liver metastases), ALP ≤ 2.5 x ULN,\n  7. International normalized ration (INR) ≤ 1.5 or prothrombin time (PT) ≤ ULN + 4 seconds.\n* Female patients must be post-menopausal or use contraceptive methods with a failure rate of \\\u003C 1% 6 months after last administration of CC-38, whatever is later, to prevent pregnancy. Male patients with fertile female partners must be willing to use condoms with spermicide, and the fertile partner must use contraceptive methods with a failure rate of \\\u003C 1% for the same time period. Male patients must also refrain from donating sperm for the same time period.\n* Successful tumor tissue sampling by surgery, including presence of TILs in the tumor tissue in the pathological evaluation.\n* Successful TIL expansion defined as obtaining the final CC-38 drug product\n\nExclusion Criteria:\n\n* Patient as any of the following condition:\n\n  1. Congestive heart failure NYHA class III or IV,\n  2. myocardial infarction or coronary artery bypass graft within 6 months prior to enrollment,\n  3. history of clinically significant ventricular arrhythmia or unexplained syncope, not believed to be vasovagal in nature or due to dehydration,\n  4. history of severe non-ischemic cardiomyopathy,\n  5. uncontrolled blood pressure as defined as systolic \\> 160 mmHg, diastolic \\> 100 mmHg within 3 months prior to enrollment,\n  6. left ventricular ejection fraction (LVEF) \\\u003C 45% as assessed by echocardiogram or multiple-gated acquisition (MUGA) scan,\n  7. any other clinically significant cardiovascular events such as unstable angina, angioplasty, stroke, or transient ischemic attack (TIA) within less than 6 months before enrolment,\n  8. other conditions that the treating physicians believe may endanger the health of the patients by their participation in this clinical trial.\n* Patient has any of the following pulmonary conditions:\n\n  1. Forced expiratory volume in 1 second (FEV1)\\\u003C60%,\n  2. Active obstructive chronic pulmonary disease,\n  3. oxygen dependence as defined by a blood oxygen saturation that can only be maintained above 92% by oxygen inhalation (finger oxygen detection method),\n  4. other pulmonary conditions that increase the anesthesiologic risk.\n* Patient has a current or history of central nervous system (CNS) metastatic disease, leptomeningeal disease, or cord compression,\n* Patient has ulcers in the upper GI tract, untreated or incompletely treated esophageal varices with high risk of bleeding in the investigator's discretion.\n* Patient requiring therapeutic anticoagulant therapy or having other increased risk of bleeding events.\n* Patient has any severe acute or chronic medical condition that places the patient at increased risk or interferes with the interpretation of trial results in the opinion of the investigator.\n* Patient has any form of primary immunodeficiency (such as severe combined immunodeficiency disease \\[SCID\\] and acquired immune deficiency syndrome \\[AIDS\\]).\n* Patient has active or history of autoimmune or inflammatory disorders. Note: Patients may be eligible if they have been assessed in discussion between Principal Investigator, Chief Medical Officer and Senior Medical Consultant as not posing an increased risk to the patient.\n* Patient receiving immunosuppressive concomitant medications (≥ 10 mg prednisone daily or other equivalent). Steroid medications are allowed if they are used as substitution or are administrated topically or as inhalations.\n* Patient has received an organ and\u002For allogenic stem cell transplant.\n* Patient has known acute or chronic infection with hepatitis B or C virus.\n* Patient has known HIV infection (seropositive for HIV antibody).\n* Patient has known infection with syphilis.\n* Patient has known bone-marrow aplasia.\n* Patient has known (chronical) urinary tract infection and\u002F or acute urothelial toxicity from previous cytotoxic chemotherapy or radiation therapy or urinary flow obstructions.\n* Female patient, who is pregnant or breast-feeding, or plan to become pregnant within 12 months after cyclophosphamide or 6 months after last dose of CC-38, whichever last. Women of childbearing potential must have a negative pregnancy test at screening and before every CC-38 application.\n* Patient is unable to comply with trial procedures, restrictions, or requirements.\n* Patient received last previous systemic cancer treatment (including anti-testosterone treatment) within less than 4 weeks prior enrollment.\n\nNote: Bridging therapies (specified in trial design \\[section 2 - subsection: screening and TIL harvesting\\]) after TIL harvesting and before CC-38 administration are permitted after consultation between Principal Investigator, Chief Medical Officer and Senior Medical Consultant.\n\n* Patient received last palliative radiotherapy within less than 4 weeks prior enrollment - where RECIST 1.1 evaluable metastases are within the radiation area.\n* Patient received minor surgery (as judged by the investigator, i.e., port implantation) within less than 3 weeks prior enrollment.\n* Patient with AEs from previous treatment that have not recovered to CTCAE v5.0 ≤ grade 1 Note: Clinically insignificant grade 2 AEs that may be allowable if discussed between and approved by Principal Investigator, Chief Medical Officer and Senior Medical Consultant.\n* Patient participates in any other interventional clinical trial or has been treated with any investigational research products within 4 weeks prior to the initiation of screening.\n* Patient has bone metastasis only.\n* Patient has known hypersensitivity to any component of the trial regimen.\n* For colorectal cancer: Patient has been diagnosed with histologically or cytologically proven BRAF-V600 positive CRC.\n* Patient has any further contraindication to the IMP pembrolizumab or any of the auxiliary medicinal products (i.e., IL-2, cyclophosphamide, uromitexan) as per current EU SmPCs to the respective product.","ALL",{"count":111,"type":21},12,[113,24],"PHASE1","This is a First-In-Human trial investigating a novel expansion protocol of an ATIMP (CC-38), composed of autologous TIL.",[116,31,117],"Metastatic Colorectal Cancer","Prostate Cancer Locally Advanced",[119,120,121,122],"mCRC","aPC","TIL","Immunotherapy","2026-06-18",{"date":125,"type":42},"2026-06-22",{"date":127,"type":42},"2025-11-13",{"date":129,"type":21},"2029-04",{"name":131,"class":132},"CuraCell TX AB","INDUSTRY",{"id":134,"slug":135,"hasResults":12,"nctId":136,"briefTitle":137,"officialTitle":138,"acronym":139,"eligibilityCriteria":140,"healthyVolunteers":12,"sex":109,"minAge":4,"maxAge":4,"enrollmentInfo":141,"targetDuration":4,"studyType":22,"phases":143,"briefSummary":145,"conditions":146,"keywords":4,"overallStatus":67,"whyStopped":4,"lastUpdateSubmitDate":147,"lastUpdatePostDateStruct":148,"startDateStruct":150,"completionDateStruct":152,"leadSponsor":154,"locationsCount":156},"100526583","phase-3-study-of-opevesostat-mk-5684-versus-alternative-nha-in-mcrpc-mk-5684-003-100526583","NCT06136624","Study of Opevesostat (MK-5684) Versus Alternative NHA in mCRPC (MK-5684-003)","A Phase 3 Randomized, Open-label Study of MK-5684 Versus Alternative Abiraterone Acetate or Enzalutamide in Participants With Metastatic Castration-resistant Prostate Cancer (mCRPC) Previously Treated With Next-generation Hormonal Agent (NHA) and Taxane-based Chemotherapy (OMAHA-003)","OMAHA-003","Inclusion Criteria:\n\n* Has histologically- or cytologically-confirmed adenocarcinoma of the prostate without small cell histology.\n* Has prostate cancer progression while on androgen deprivation therapy (or post bilateral orchiectomy) within 6 months before Screening\n* Has current evidence of distant metastatic disease (M1 disease) documented by either bone lesions on bone scan and\u002For soft tissue disease by computed tomography\u002Fmagnetic resonance imaging (CT\u002FMRI).\n* Has disease that progressed during or after treatment with 1 novel hormonal agent (NHA)\n* Has received 1 but no more than 2 taxane-based chemotherapy regimens for metastatic castration-resistant prostate cancer (mCRPC) and has had progressive disease (PD) during or after treatment\n* Has ongoing androgen deprivation with serum testosterone \\\u003C50 ng\u002FdL (\\\u003C1.7 nM)\n* Has provided tumor tissue from a fresh core or excisional biopsy from soft tissue not previously irradiated\n* Has an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 assessed within 7 days of randomization\n* Has had prior treatment with PARPi or were deemed ineligible to receive treatment by the investigator or have refused PARPi treatment\n* Has received prior 177Lu-PSMA-617 or were deemed ineligible to receive 177Lu-PSMA-617 treatment by the investigator or refused 177Lu-PSMA-617 treatment\n* Participants who have not received cabazitaxel can be enrolled if they are ineligible for cabazitaxel treatment as determined by the investigator or have refused treatment\n* If participant received first generation anti-androgen therapy before screening, the participant has evidence of disease progression \\>4 weeks since the last flutamide treatment and \\>6 weeks since the last bicalutamide or nilutamide treatment\n* Participants receiving bone resorptive therapy (including, but not limited to, bisphosphonate or denosumab) must have been on stable doses for ≥ 4 weeks before the date of randomization\n* Participants with human immunodeficiency virus (HIV) infection must have well controlled HIV on antiretroviral therapy (ART)\n* Participants who are hepatitis B surface antigen (HBsAg) positive are eligible if they have received hepatitis B virus (HBV) antiviral therapy for at least 4 weeks and have undetectable HBV viral load before randomization\n* Participants with history of hepatitis C virus (HCV) infection are eligible if HCV viral load is undetectable at Screening.\n* Participants who can produce sperm must agree to the following during the study treatment period and for at least 7 days after the last dose of opevesostat, for at least 30 days after the last dose of abiraterone acetate, and for at least 3 months after the last dose of enzalutamide: EITHER be abstinent OR must agree to use male condom\n\nExclusion Criteria:\n\n* Has a gastrointestinal disorder that might affect absorption\n* Has a history of pituitary dysfunction\n* Has poorly controlled diabetes mellitus\n* Has clinically significant abnormal serum potassium or sodium level\n* Has a history of active or unstable cardio\u002Fcerebro-vascular disease, including thromboembolic events\n* Has a history of seizure within 6 months of providing documented informed consent or any condition that may predispose to seizures within 12 months before the date of randomization\n* Has a history of clinically significant ventricular arrhythmias\n* Has received an anticancer monoclonal antibody (mAb) within 4 weeks before the date of randomization, or has not recovered from adverse events (AEs) due to mAbs administered more than 4 weeks before the date of randomization\n* Has undergone major surgery, including local prostate intervention (except prostate biopsy), within 28 days before the date of randomization, and has not recovered from the toxicities and\u002For complications\n* Participants who have not adequately recovered from major surgery or have ongoing surgical complications\n* Has used herbal or medicinal products that may have hormonal anti-prostate cancer activity and\u002For are known to decrease prostate-specific Antigen (PSA) (eg, saw palmetto, megesterol acetate, citrus pectin polysaccharide) within 4 weeks before the date of randomization\n* Has received radium-223 or lutetium-177 within 4 weeks before the date of randomization, or has not recovered to Grade ≤1 or baseline from AEs due to radium-223 or lutetium-177 administered more than 4 weeks before the date of randomization\n* Has received treatment with 5-αreductase inhibitors (eg, finasteride or dutasteride), estrogens, or cyproterone within 4 weeks before the date of randomization\n* Has received colony-stimulating factors within 28 days before the date of randomization\n* Has received a whole blood transfusion in the last 120 days before the date of randomization. Packed red blood cells and platelet transfusions are acceptable if not given within 28 days of the date of randomization\n* Has received prior targeted small molecule therapy or NHA treatment within 4 weeks before the first dose of study intervention as follows: enzalutamide or apalutamide within 3 weeks or abiraterone acetate + prednisone or darolutamide within 2 weeks\n* Has a \"superscan\" bone scan\n* Has a diagnosis of immunodeficiency or is receiving chronic systemic steroid therapy or any other form of immunosuppressive therapy within 7 days prior the first dose of study medication\n* Has a known additional malignancy that is progressing or has required active treatment within the past 3 years\n* Has known active central nervous system (CNS) metastases and\u002For carcinomatous meningitis\n* Has an active autoimmune disease that has required systemic treatment in past 2 years\n* Has an active infection requiring systemic therapy\n* Has concurrent active HBV or known active HCV infection\n* Has a history of long QTc syndrome\n* Has any of the following at Screening Visit: hypotension (systolic BP \\\u003C110 mm Hg) or uncontrolled hypertension (systolic BP ≥160 mm Hg or diastolic BP ≥90 mm Hg, in 2 out of 3 recordings with optimized antihypertensive therapy)\n* Is unable to swallow capsules\u002Ftablets\n* Is currently being treated with cytochrome 450-inducing antiepileptic drugs for seizures\n* Participants on an unstable dose of thyroid hormone therapy within 6 months before the start of the study intervention\n* Received prior systemic anticancer therapy including investigational agents within 4 weeks before the first dose of study intervention\n* Received prior radiotherapy within 2 weeks of start of study intervention, or radiation-related toxicities, requiring corticosteroids\n* Received a live or live-attenuated vaccine within 30 days before the first dose of study intervention\n* Systemic use of the following medications within 2 weeks before the first dose of study intervention: strong CYP3A4 inducers (eg, avasimibe, carbamazepine, lumacaftor, phenobarbital, rifampicin, rifapentine, or St John's Wort); P-gp inhibitors (eg, erythromycin, clarithromycin, rifampicin, ketoconazole, itraconazole, posaconazole, artesunate-pyronaridine, ritonavir, indinavir, nelfinavir, atazanavir, glecaprevir-pibrentasvir, simeprevir, ledipasvir-sofosbuvir, verapamil, diltiazem, dronedarone, propafenone, quinidine, cyclosporine, valspodar, or milk thistle \\[Silybum marianum\\])\n* Use of aldosterone antagonist (eg, spironolactone, eplerenone) and phenytoin within 4 weeks before the start of the study intervention",{"count":142,"type":21},1310,[144],"PHASE3","This is a phase 3, randomized, open-label study of opevesostat compared to alternative abiraterone acetate or enzalutamide in participants with metastatic castration-resistant prostate cancer (mCRPC) with respect to overall survival (OS) in participants with mCRPC previously treated with next-generation hormonal agent (NHA) and taxane-based chemotherapy. It is hypothesized that opevesostat is superior with respect to OS in androgen receptor ligand binding domain (AR LBD) mutation-negative and -positive participants.",[31],"2026-05-04",{"date":149,"type":42},"2026-05-05",{"date":151,"type":42},"2023-12-31",{"date":153,"type":21},"2030-02-15",{"name":155,"class":132},"Merck Sharp & Dohme LLC",282,{"id":158,"slug":159,"hasResults":12,"nctId":160,"briefTitle":161,"officialTitle":162,"acronym":163,"eligibilityCriteria":164,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":165,"targetDuration":4,"studyType":22,"phases":167,"briefSummary":168,"conditions":169,"keywords":170,"overallStatus":67,"whyStopped":4,"lastUpdateSubmitDate":172,"lastUpdatePostDateStruct":173,"startDateStruct":175,"completionDateStruct":177,"leadSponsor":179,"locationsCount":181},"100432861","phase-3-adt---darolutamide-in-de-novo-metastatic-prostate-cancer-patients-with-vulnerable-functional-ability-peace6-vulnerable-100432861","NCT04916613","ADT +\u002F- Darolutamide in de Novo Metastatic Prostate Cancer Patients With Vulnerable Functional Ability (PEACE6-Vulnerable)","A Double-blind Randomised Phase III Trial Evaluating the Efficacy of ADT +\u002F- Darolutamide in de Novo Metastatic Prostate Cancer Patients With Vulnerable Functional Ability and Not Elected for Docetaxel or Androgen Receptor Targeted Agents","GETUG-AFU 40","Inclusion Criteria:\n\n1. Signed a written informed consent form prior to any trial specific procedures.\n2. Men with histologically or cytologically confirmed adenocarcinoma of the prostate.\n3. Aged ≥18 years old at the time of signing informed consent.\n4. De novo metastatic disease defined by clinical or radiological evidence of metastases.\n\n   Note: For patients with nodal metastases only, only patients with extra-pelvic enlarged lymph nodes (lymph nodes located above the iliac bifurcation) can be included if they have either:\n   * At least one extra-pelvic lymph node ≥2 cm\n   * At least one extra-pelvic lymph node ≥1 cm if the patients also have at least one pelvic lymph node ≥2 cm\n5. Measurable disease or bone lesions that are evaluable according to PCWG3 criteria.\n6. Ineligible for treatment with all of the following drugs: docetaxel, abiraterone, enzalutamide, apalutamide; AND meets at least one of the following frailty criteria:\n\n   1. Activities of daily living (ADL) assessment (excluding urinary incontinence question) score 3 or 4\u002F5, or;\n   2. 4-Instrumental activities of daily living (4-IADL) assessment score 2 or 3\u002F4, or;\n   3. A Grade 3 event on the Cumulative Illness Score Rating-Geriatrics (CISR-G) questionnaire, or;\n   4. Body mass index (BMI) ≤21 kg\u002Fm² and\u002For \\>5% weight loss in the last 6 months, or;\n   5. Timed up and go test (TUG) \\>14 sec. Nota Bene: Regarding CISR-G assessment, more specifically genitourinary scoring, score N°4 is not applicable.\n7. Adequate bone marrow function: haemoglobin ≥80 g\u002FL, white blood cells ≥3.0 x10⁹\u002FL and platelets ≥80 x10⁹\u002FL.\n8. Adequate liver function: alanine aminotransferase (ALT) \\\u003C2 x upper limit of normal (ULN) and bilirubin \\\u003C1.5 x ULN, (or if bilirubin is between 1.5-2 x ULN, they must have a normal conjugated bilirubin). For patients with documented liver metastasis, ALT \\\u003C5 x ULN is acceptable.\n9. Adequate renal function: calculated creatinine clearance \\>30 ml\u002Fmin (using the Modification of Diet in Renal Disease \\[MDRD\\] or Chronic Kidney Disease Epidemiology Collaboration \\[CKD EPI) method).\n10. For sexually active men, agreement to use adequate contraception for the duration of trial participation and up to 2 weeks after completing study treatment.\n11. Affiliated to the social security system or in possession of equivalent private health insurance (according to local regulations for participation in clinical trials).\n12. Willing and able to comply with the protocol for the duration of the trial including undergoing treatment and scheduled visits, and examinations including follow-up.\n\nExclusion Criteria:\n\n1. Three or more Grade 3, or any Grade 4 events on the CISR-G questionnaire. Nota Bene: (Regarding CISR-G assessment, more specifically genitourinary scoring, score N°4 is not applicable).\n2. Eastern Cooperative Oncology Group (ECOG) performance status score ≥3.\n3. Hypertension not controlled by an anti-hypertensive treatment (systolic blood pressure \\[BP\\] ≥160 mmHg or diastolic BP ≥95 mmHg; 3 consecutive measures taken 5 minutes apart).\n4. Acute toxicities of prior treatments and procedures not resolved to grade ≤1 or baseline before randomisation, with the exception of hot flushes and erectile dysfunction.\n5. Previous systemic treatment for prostate cancer, except less than 12 weeks of ADT and\u002For an old-generation AR inhibitor.\n6. Severe or uncontrolled concurrent disease, infection or co-morbidity.\n7. Known hypersensitivity to the study treatment or any of its ingredients.\n8. Major surgery within 28 days before randomisation.\n9. Any of the following within 6 months before randomisation: stroke, myocardial infarction, severe\u002Funstable angina pectoris, coronary\u002Fperipheral artery bypass graft; congestive heart failure New York Heart Association (NYHA) Class III or IV.\n10. Prior malignancy ≤3 years before study enrolment. Adequately treated basal cell or squamous cell carcinoma of skin or superficial bladder cancer that has not spread behind the connective tissue layer (i.e., pTis, pTa, and pT1) is allowed, as well as any localized cancer for which treatment has been completed ≥6 months before randomisation and from which the subject has been disease-free, or for which the risk of relapse is less than 30%, as well as early stage chronic lymphocytic leukaemia that does not require any specific treatment.\n11. Inability to swallow oral medications.\n12. Gastrointestinal disorder or procedure that can be expected to interfere significantly with the absorption of study treatment.\n13. Known to have active viral hepatitis, active human immunodeficiency virus (HIV) or chronic liver disease at screening.\n14. Treatment with any investigational product within 28 days before randomisation.\n15. Concurrent participation in another clinical trial involving an investigational product (patients enrolled in non-experimental trials with no modification of the standard of care can be included).\n16. Individual deprived of liberty or placed under the authority of a tutor.\n17. Significantly altered mental status prohibiting the understanding of the study or with psychological, familial, sociological or geographical condition potentially hampering compliance with the study protocol and follow-up schedule or any condition that, in the opinion of the investigator, would preclude participation in this trial.",{"count":166,"type":21},300,[144],"This is a Phase III, international, multicentre, randomised, double-blinded placebo controlled trial, evaluating the efficacy and safety of ADT +\u002F- darolutamide in castration-naïve de novo metastatic prostate cancer patients with vulnerable functional ability who have not elected for docetaxel or other androgen receptor pathway inhibitors.",[31],[171],"PEACE 6 -Vulnerable","2026-04-22",{"date":174,"type":42},"2026-04-28",{"date":176,"type":42},"2022-04-19",{"date":178,"type":21},"2037-09",{"name":180,"class":49},"UNICANCER",95,{"id":183,"slug":184,"hasResults":12,"nctId":185,"briefTitle":186,"officialTitle":186,"acronym":187,"eligibilityCriteria":188,"healthyVolunteers":12,"sex":17,"minAge":189,"maxAge":4,"enrollmentInfo":190,"targetDuration":4,"studyType":86,"phases":4,"briefSummary":192,"conditions":193,"keywords":198,"overallStatus":67,"whyStopped":4,"lastUpdateSubmitDate":213,"lastUpdatePostDateStruct":214,"startDateStruct":216,"completionDateStruct":218,"leadSponsor":220,"locationsCount":222},"100630230","study-of-the-epidemiological-clinical-diagnostic-and-therapeutic-characteristics-of-prostate-cancers-in-algeria-100630230","NCT07484971","Study of the Epidemiological, Clinical, Diagnostic, and Therapeutic Characteristics of Prostate Cancers in Algeria","CLIQQC","Inclusion Criteria:\n\n* Patients aged 19 years and older.\n* Diagnosis of prostate cancer confirmed histologically and\u002For biologically.\n* Patients followed in the participating oncology departments.\n* Written informed consent obtained.\n\nNon Inclusion Criteria:\n\n* Histological types other than carcinoma\n* Secondary tumors\n* Participation in an interventional study","19 Years",{"count":191,"type":21},2000,"The goal of this observational study is to describe the demographic, epidemiological, clinical, and outcome characteristics of patients with prostate cancer.\n\nIt also aims to analyze the diagnostic approaches and management strategies used in the care of these patients in Algeria.",[27,194,195,196,31,197],"Prostate Cancer (Diagnosis)","Prostate Cancer (Post Prostatectomy)","Prostate Cancer Patients Treated by Radiotherapy","Prostate Cancer (Adenocarcinoma)",[199,200,27,201,202,203,204,205,206,207,208,209,210,211,212],"oncology","patient outcome","Prostate Cancer in Algerian patients","Observational Study","Retrospective data","Treatment strategies","Diagnostic approaches","Clinical characteristics","Epidemiological data","Demographic data","Cross-sectional study","Real-world data","Algeria","Algerian Study","2026-04-14",{"date":215,"type":42},"2026-04-17",{"date":217,"type":42},"2025-07-21",{"date":219,"type":21},"2026-07-21",{"name":221,"class":49},"Société Algérienne de Formation et Recherche en Oncologie",24,{"id":224,"slug":225,"hasResults":12,"nctId":226,"briefTitle":227,"officialTitle":228,"acronym":4,"eligibilityCriteria":229,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":230,"targetDuration":4,"studyType":22,"phases":232,"briefSummary":233,"conditions":234,"keywords":4,"overallStatus":67,"whyStopped":4,"lastUpdateSubmitDate":213,"lastUpdatePostDateStruct":235,"startDateStruct":237,"completionDateStruct":239,"leadSponsor":241,"locationsCount":50},"100529235","tumor-genomic-pre-test-counseling-tool-for-black-or-african-american-men-with-prostate-cancer-100529235","NCT06171139","Tumor Genomic Pre-test Counseling Tool for Black or African-American Men With Prostate Cancer","Developing and Testing a Patient-centered Tumor Genomic Pre-test Counseling Tool for Black or African-American Men With Metastatic Prostate Cancer","Inclusion Criteria:\n\nStage 1:\n\n1. Age 18-years-old or older\n2. Identifies as Black or African American, by either chart documentation or participant self-report. Mixed-race, including Black or African American, is included.\n3. Metastatic prostate cancer, by either chart documentation or participant self-report. Pathology report not needed.\n4. Able to understand study procedures and to comply with them for the entire length of the study.\n5. Able to understand a written information sheet and willing to verbally consent.\n6. Fluent in English (reading, writing, and speaking)\n\nStage 2:\n\n1. Age 18-years-old or older\n2. Identifies as Black or African American, by either chart documentation or participant self-report. Mixed-race, including Black or African American, is included.\n3. Metastatic prostate cancer, by either chart documentation or participant self-report. Pathology report not needed.\n4. Able to understand study procedures and to comply with them for the entire length of the study.\n5. Fluent in English (reading, writing, and speaking).\n6. Anticipated discussion of TGT within 0-365 days of enrollment, per treating oncology provider's discretion. TGT involves the use of any cancer genetic sequencing (whether standard-of-care or part of a research protocol) via any one of the following:\n\n   1. Somatic DNA testing of already-collected tissue.\n   2. Somatic DNA testing of tissue to be collected in the future via biopsy, surgery, or other procedure.\n   3. Blood-based DNA testing to evaluate for circulating tumor DNA.\n7. Able to understand a written informed consent document and willing to sign it.\n\nExclusion Criteria:\n\nContraindication to any study-related procedure or assessment in either stage.",{"count":231,"type":21},80,[61],"The overall goal of the study is to improve equitable delivery of pre-Tumor genetic testing (TGT) counseling tool for Black or African American men with metastatic prostate cancer and evaluating the tool for implementation.",[27,31],{"date":236,"type":42},"2026-04-16",{"date":238,"type":42},"2023-12-01",{"date":240,"type":21},"2027-08-31",{"name":242,"class":49},"University of California, San Francisco",{"id":244,"slug":245,"hasResults":12,"nctId":246,"briefTitle":247,"officialTitle":248,"acronym":249,"eligibilityCriteria":250,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":251,"targetDuration":4,"studyType":22,"phases":253,"briefSummary":254,"conditions":255,"keywords":257,"overallStatus":67,"whyStopped":4,"lastUpdateSubmitDate":265,"lastUpdatePostDateStruct":266,"startDateStruct":268,"completionDateStruct":270,"leadSponsor":272,"locationsCount":50},"100563027","phase-2-castrate-resistant-prostate-cancer-enhertu-therapy-100563027","NCT06610825","Castrate Resistant Prostate Cancer Enhertu Therapy","A Phase II Clinical Trial to Evaluate the Efficacy and Safety of Fam-Trastuzumab Deruxtecan-Nxki (T-DXd) as a Subsequent Line of Therapy in HER2-Positive Metastatic Castration-Resistant Prostate Adenocarcinoma","CaRPET","Inclusion Criteria:\n\n* Pathologically confirmed adenocarcinoma of the prostate\n* Diagnosis of mCRPC\n* Documented progression on androgen deprivation and novel hormonal agents, with or without progression on taxane containing regimen\n* Ongoing ADT to maintain serum testosterone levels below 50 ng\u002FdL\n* Formalin fixed paraffin embedded tumor tissue for HER2 immunohistochemistry\n* Life expectancy 6 months\n* ECOG 0 or 1\n* LVEF at least 50%\n* Adequate Blood Clotting function\n* Adequate Organ and Bone Marrow function\n* Adequate Renal function\n* Adequate Hepatic function\n\nExclusion Criteria:\n\n* History of interstitial lung disease or pneumonitis requiring steroids\n* Significant coronary vascular disease\n* Previous exposure to HER2 targeted therapy",{"count":252,"type":21},60,[24],"Use of Enhertu as a Subsequent Line of Therapy in HER2-Positive Metastatic Castration-Resistant Prostate Adenocarcinoma.",[31,27,256],"CRPC",[258,259,260,261,262,263,264],"prostate cancer","metastatic prostate cancer","Enhertu","HER2 positive","Trastuzumab deruxtecan","crpc","phase 2","2026-04-06",{"date":267,"type":42},"2026-04-13",{"date":269,"type":42},"2025-03-05",{"date":271,"type":21},"2028-10",{"name":273,"class":274},"Washington D.C. Veterans Affairs Medical Center","FED",{"id":276,"slug":277,"hasResults":12,"nctId":278,"briefTitle":279,"officialTitle":279,"acronym":280,"eligibilityCriteria":281,"healthyVolunteers":12,"sex":17,"minAge":4,"maxAge":4,"enrollmentInfo":282,"targetDuration":4,"studyType":22,"phases":283,"briefSummary":284,"conditions":285,"keywords":4,"overallStatus":67,"whyStopped":4,"lastUpdateSubmitDate":286,"lastUpdatePostDateStruct":287,"startDateStruct":289,"completionDateStruct":291,"leadSponsor":293,"locationsCount":50},"100474422","phase-2-ablative-radiotherapy-to-consolidate-maximal-systemic-response-in-metastatic-prostate-cancer-anchor-prostate-100474422","NCT05457699","Ablative Radiotherapy to Consolidate Maximal Systemic Response in Metastatic Prostate Cancer (ANCHOR-Prostate)","ANCHORProstate","Inclusion Criteria:\n\n* Enrolled in PERa (CHUM CER 17.032) and randomly selected for ANCHOR-Prostate.\n* Diagnosis of hormone-sensitive metastatic prostate cancer having responded to systemic therapy.\n* PSA non-progressing\n* ECOG 0-2\n* Metastatic disease suitable for MDRT.\n* Primary tumor must have received definitive local treatment (surgery or radiotherapy) with no evidence of local recurrence, or be planned for treatment at the time of MDRT.\n\nExclusion Criteria:\n\n* Planned intermittent systemic therapy.\n* Planned radio-ligand therapy.",{"count":231,"type":21},[24],"This will be a pragmatic, phase II, registry-based cohort-multiple randomized controlled trial (cmRCT) embedded within an ongoing prospective cancer radiotherapy registry. Eligible patients are those with hormone-sensitive metastatic prostate cancer who have responded to systemic therapy, defined by the absence of PSA progression, and who are eligible for MDRT. All eligible subjects will be enrolled into the registry and followed longitudinally for oncologic and toxicity outcomes.\n\nFrom this registry, patients will be randomly selected (1:1) to be offered the experimental arm, which consists of MDRT delivered to metastatic sites identified on imaging in patients who have already initiated systemic therapy (Figure 1). Those not selected will continue to receive standard of care systemic therapy +\u002F- standard of care radiotherapy if clinically indicated. Nor patients or physicians will be blinded.\n\nFollowing the initial course of MDRT, prostate-specific antigen (PSA) will be measured, with a minimum assessment at 3 months. This PSA value will be used to determine whether the PSA level has decreased below 0.2 ng\u002FmL. If the PSA remains ≥ 0.2 ng\u002FmL, repeat PSMA-PET will be performed, and a second course of MDRT will be delivered to consolidate residual metastatic lesions.\n\nIn this phase II real-world randomized trial, we will determine if AnChoRing (Addition of MDRT for consolidation of response) sites of PSMA PET visible disease when responding to systemic therapy improves the proportion of patients achieving a PSA \\\u003C 0.2 ng\u002FmL and extends failure-free survival compared to the standard of care.",[31],"2026-04-02",{"date":288,"type":42},"2026-04-08",{"date":290,"type":42},"2022-12-30",{"date":292,"type":21},"2030-07-30",{"name":294,"class":49},"Centre hospitalier de l'Université de Montréal (CHUM)",{"id":296,"slug":297,"hasResults":12,"nctId":298,"briefTitle":299,"officialTitle":300,"acronym":4,"eligibilityCriteria":301,"healthyVolunteers":12,"sex":17,"minAge":4,"maxAge":4,"enrollmentInfo":302,"targetDuration":4,"studyType":86,"phases":4,"briefSummary":304,"conditions":305,"keywords":4,"overallStatus":38,"whyStopped":4,"lastUpdateSubmitDate":306,"lastUpdatePostDateStruct":307,"startDateStruct":309,"completionDateStruct":311,"leadSponsor":313,"locationsCount":4},"100630300","18f-psma-petct-versus-ct-alone-in-assessment-of-prostatic-cancer-patients-100630300","NCT07485881","18F-PSMA PET\u002FCT Versus CT Alone in Assessment of Prostatic Cancer Patients","18F-PSMA PET\u002FCT Versus CT Alone in Initial Staging, Assessment of Therapy Response and Evaluation of Biochemical Recurrence in Prostatic Cancer Patients","Inclusion Criteria:\n\nPatients with known prostate cancer referred for 18-F PSMA PET\u002FCT study\n\nExclusion Criteria:\n\n* Patients with claustrophobia\n* Patients refuse to do the scan",{"count":303,"type":21},59,"To compare the diagnostic performance of 18-F PSMA PET\u002FCT and CT alone in initial staging, assessment of therapy response, as well as evaluation of biochemical recurrence of prostatic cancer patients\n\nThe main question it aims to answer is:\n\nDoes 18-F PSMA PET\u002FCT have a superior role over CT in evaluation of prostatic cancer patients?",[27,31,30],"2026-03-17",{"date":308,"type":42},"2026-03-20",{"date":310,"type":21},"2026-05-01",{"date":312,"type":21},"2028-06",{"name":314,"class":49},"Assiut University",{"id":316,"slug":317,"hasResults":12,"nctId":318,"briefTitle":319,"officialTitle":320,"acronym":321,"eligibilityCriteria":322,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":323,"targetDuration":325,"studyType":86,"phases":4,"briefSummary":326,"conditions":327,"keywords":329,"overallStatus":67,"whyStopped":4,"lastUpdateSubmitDate":333,"lastUpdatePostDateStruct":334,"startDateStruct":336,"completionDateStruct":338,"leadSponsor":340,"locationsCount":342},"100599827","psma-pet-for-treatment-response-evaluation-of-systemic-therapies-in-prostate-cancer-pelican-100599827","NCT07089550","PSMA PET for Treatment Response evaLuation of systemIC Therapies in prostAte caNcer (PELICAN)","PSMA PET for Treatment Response evaLuation of systemIC Therapies in prostAte caNcer (PELICAN), an Italian Multicenter Study","PELICAN","Inclusion Criteria:\n\n* Histological diagnosis of advanced prostate cancer (excluding neuroendocrine carcinoma);\n* Patients undergoing PSMA PET for pre-treatment disease staging;\n* Candidates to receive one or more of the following systemic therapies, in combination or alone: abiraterone, enzalutamide, apalutamide, darolutamide, docetaxel, cabazitaxel, olaparib, radiotherapy, lutetium-177-PSMA, actinium-225-PSMA;\n* Provision of signed informed consent for study participation and data handling.\n\nExclusion Criteria:\n\n* Inability to remain supine and still for the PET\u002FCT image acquisition;\n* Prostate cancer with a known significant neuroendocrine component;\n* Presence of another concurrent malignancy, with the exception of non-melanoma skin cancer.",{"count":324,"type":21},1300,"2 Years","This prospective clinical study aims to evaluate the predictive power of PSMA PET imaging in patients with advanced prostate cancer who are receiving systemic drug therapies.\n\nThe primary goal is to identify prognostic factors derived from PSMA PET imaging. These factors include the number of cancer lesions, the size of the tumor, and measurements known as SUVmax and SUVmean. By identifying these factors, the investigators aim to better group patients and predict those who may have a less favorable outcome. While PSMA PET imaging is highly accurate in locating cancer sites within the body, its ability to predict treatment response has not yet been thoroughly studied in a prospective manner for this patient population.\n\nThis study will assess the predictive role of PSMA PET imaging and its ability to forecast treatment response across a range of systemic therapies, including hormone therapy and chemotherapy, in patients with both hormone-sensitive (HSPC) and castration-resistant (CRPC) prostate cancer.",[328,31],"PSMA Positive Tumors or Tumor Tissues",[330,331,332],"PSMA PET\u002FCT","mCRPC","mHSPC","2026-02-19",{"date":335,"type":42},"2026-02-20",{"date":337,"type":42},"2025-04-02",{"date":339,"type":21},"2034-04-26",{"name":341,"class":49},"IRCCS Azienda Ospedaliero-Universitaria di Bologna",4,{"id":344,"slug":345,"hasResults":12,"nctId":346,"briefTitle":347,"officialTitle":347,"acronym":348,"eligibilityCriteria":349,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":350,"targetDuration":4,"studyType":22,"phases":352,"briefSummary":353,"conditions":354,"keywords":357,"overallStatus":67,"whyStopped":4,"lastUpdateSubmitDate":361,"lastUpdatePostDateStruct":362,"startDateStruct":364,"completionDateStruct":366,"leadSponsor":368,"locationsCount":370},"100437962","metastasis-directed-stereotactic-body-radiotherapy-for-oligo-metastatic-hormone-sensitive-prostate-cancer-100437962","NCT04983095","Metastasis Directed Stereotactic Body Radiotherapy for Oligo Metastatic Hormone Sensitive Prostate Cancer","METRO","Inclusion Criteria:\n\n1. Histologically confirmed prostate cancer (ICD-O-3 C61)\n2. WHO\u002FECOG performance status 0-1\n3. 1-3 skeletal or extra pelvic lymph node metastases detected by PSMA-PET\u002FCT in de novo prostate cancer or PSA-relapse after definitive RT or prostatectomy\n4. Willing and able to provide informed consent-\n\nExclusion Criteria:\n\n1. Castration resistant prostate cancer (progression with castrate levels of testosterone)\n2. Any treatment known to affect PSA (including ADT) for prostate cancer within 6 months (exception: ADT started due to oligometastatic disease within 2 weeks of study entry)\n3. Patient eligible for other treatment (e.g., early docetaxel) than standard treatment described in the protocol as judged by treating physician\n4. Life expectancy \\\u003C3 years by any reason, including concomitant or previous malignancies\n5. Previous radiotherapy or surgery that may interfere with the planned treatment (including intra-prostatic recurrence if previous RT to the prostate)\n6. \\> 3 PSMA-PET\u002FCT positive target lesions (excluding the prostate and regional lymph node metastasis in de novo patients or prostate bed and or regional lymph node metastasis in recurrent patients)\n7. PSMA-PET verified metastases other than skeletal or lymph nodes\n8. Metastases in base of scull and\u002For calotte\n9. Any target lesions not treatable with image guided RT (IGRT) due to overlap with previous RT fields or exceeded dose constraint to OAR(s) as specified in study protocol",{"count":351,"type":21},118,[61],"The study is an open label, multi-centre, randomized phase III study. The patients will be randomised in a 1:1 ratio to treatment consisting of\n\n* Arm A: MD-SBRT in addition to standard treatment\n* Arm B: Standard treatment\n\nStudy population: Patients with hormone sensitive prostate cancer (HSPC) with oligometastatic disease detected by PSMA-PET\u002FDT. This includes patients with de novo oligometastatic HSPC and recurrent HSPC after primary RT or prostatectomy.\n\nPrimary endpoint: Failure free survival\n\nSecondary endpoints:\n\n* Predictive value of investigated biomarkers in blood and imaging\n* Acute and late toxicity after MD-SBRT\n* PROM at 3 months, 1, 3 and 5 years\n* Castration resistant prostate cancer, CRPC\n* Overall survival\n* Differences in outcome between patients by strata\n\nStratification: To avoid imbalance between treatment arms the minimisation method will be used to achieve balance between de novo oligo-metastatic and oligo-recurrent patients, as well as treatment site.\n\nSafety evaluation: Adverse events and side effects graded according to CTCAE v5.0 will be collected every 6th month. Serious Adverse Events are to be reported within 24 hours throughout the study duration.\n\nStatistical methods: Survival endpoints will be calculated using the Kaplan-Meier method with differences compared using the stratified log-rank test. Randomization time is set as baseline time. Pre-planned subgroup analysis will occur based on pre-specified stratification variables. A Cox multivariable regression model will be used to determine factors predictive of survival. Safety analysis will be performed with Mann-Whitney U-test or Fishers exact test.\n\nCriteria for evaluation: Per protocol (patients that have started study treatment) and Intention to treat (all included patients).\n\nPlanned sample size: 118 patients\n\nAnalysis plan:\n\nThe primary end point will be analysed after pre-specified number of events have occurred. All patients randomised to SBRT will be followed minimum 60 months for toxicity. Safety analysis of acute toxicity will take place after median follow up of 6 months. Safety analysis of late toxicity will be analysed after study closure.\n\nDuration of the study:\n\nThree to five years inclusion. 72 months of follow-up after randomization of the last patient.",[31,355,356],"Radiation Therapy","Positron-Emission Tomography",[358,359,360],"Oligometastatic Prostate Cancer","Hormone Sensitive","Stereotactic Body Radiotherapy","2026-02-11",{"date":363,"type":42},"2026-02-17",{"date":365,"type":42},"2021-10-27",{"date":367,"type":21},"2033-12",{"name":369,"class":49},"Karin Soderkvist",7,{"id":372,"slug":373,"hasResults":12,"nctId":374,"briefTitle":375,"officialTitle":376,"acronym":377,"eligibilityCriteria":378,"healthyVolunteers":12,"sex":109,"minAge":18,"maxAge":4,"enrollmentInfo":379,"targetDuration":4,"studyType":22,"phases":381,"briefSummary":382,"conditions":383,"keywords":388,"overallStatus":67,"whyStopped":4,"lastUpdateSubmitDate":398,"lastUpdatePostDateStruct":399,"startDateStruct":401,"completionDateStruct":403,"leadSponsor":405,"locationsCount":407},"100615404","phase-1-a-phase-1b2-study-of-the-safety-and-efficacy-of-the-monoclonal-antibody-om-rca-01-in-patients-with-metastatic-tumors-expressing-fibroblast-growth-factor-receptor-1-100615404","NCT07292168","A Phase 1b\u002F2 Study of the Safety and Efficacy of the Monoclonal Antibody OM-RCA-01 in Patients With Metastatic Tumors Expressing Fibroblast Growth Factor Receptor 1","A Phase 1b\u002F2 Study Evaluating the Safety and Preliminary Efficacy of OM-RCA-01, an Anti-FGFR1 Monoclonal Antibody, in Patients With Metastatic Cancers Expressing FGFR1.","TAGNOT","Inclusion Criteria:\n\n1. Signed and dated Informed Consent Form confirming voluntary participation in the study.\n2. Age ≥ 18 years at the time of consent.\n3. Body weight ≥ 50 kg.\n4. Histologically confirmed metastatic solid tumors:\n\n   1. clear-cell renal cell carcinoma;\n   2. non-small cell lung cancer (adenocarcinoma or squamous cell cancer without EGFR and ALK mutations);\n   3. prostate cancer (castration-resistant adenocarcinoma);\n   4. breast cancer (adenocarcinoma with specified status for estrogen receptors, progesterone receptors, HER2);\n   5. head and neck tumors (squamous carcinoma, salivary gland cancer).\n5. Immunohistochemical expression of FGFR1 of 2+ or higher.\n6. Documented disease progression after at least two lines of standard therapy, or lack of available or feasible alternative standard treatment options for any reason.\n7. Presence of at least one measurable lesion according to RECIST 1.1 criteria.\n8. Availability of formalin-fixed and paraffin-embedded tumor tissue samples for biomarker analysis.\n9. ECOG performance status 0 or 1.\n10. Adequate organ function, confirmed by laboratory test results obtained within 7 days prior to Cycle 1 Day 1, meeting the following parameters:\n\n    * Hemoglobin level ≥ 90 g\u002FL\n    * Absolute neutrophil count (ANC) ≥ 1.5 × 10⁹\u002FL\n    * Platelet count ≥ 100 × 10⁹\u002FL\n    * Serum creatinine level ≤ 1.5 × upper limit of normal (ULN)\n    * Glomerular Filtration Rate (GFR) ≥ 30 mL\u002Fmin\n    * AST and ALT ≤ 3 × ULN (≤ 5 × ULN in patients with liver metastases)\n    * Serum phosphorus within normal limits (≥ lower limit of normal and ≤ upper limit of normal)\n    * Serum calcium ≥ lower limit of normal\n    * Serum potassium ≥ lower limit of normal (note: use of medications to increase potassium during screening is permitted)\n11. Life expectancy of more than 12 weeks.\n12. Absence of any psychological, familial, social or geographical circumstances that could potentially serve as an obstacle to the fulfillment of the study protocol and follow-up procedures according to the prescribed schedule and the ability of the study participant to follow the requirements of the protocol; these circumstances should be discussed with the patient before inclusion in the study.\n13. Women capable of childbearing must be using an effective method of contraception.\n\nExclusion Criteria:\n\n1. Participation in another clinical trial or concomitant treatment with any investigational drug, or administration of any investigational anticancer therapy within 28 days prior to inclusion in this study.\n2. Presence of central nervous system (CNS) metastases and\u002For medullary carcinomatosis at the time of inclusion.\n\n   Exception: Patients with CNS metastases who have received therapy may participate if they have been clinically stable for at least 1 month prior to enrollment, defined by:\n   * No evidence of new or progressive CNS metastases\n   * No ongoing steroid therapy\n   * Stable mental status sufficient to provide informed consent\n3. History of or current evidence of any condition, therapy, or laboratory abnormality that could:\n\n   * Limit interpretation of study results,\n   * Prevent completion of the study protocol, or\n   * Pose a risk to patient safety or well-being. This includes any serious or unstable general medical, psychiatric, or other conditions potentially jeopardizing safety, informed consent, or compliance.\n4. Any second malignancy within the previous 5 years, except for adequately treated cervical carcinoma in situ, squamous cell carcinoma of the skin, or basal cell carcinoma of the skin with limited growth, provided these are well controlled.\n5. Known regular use of illicit substances or recreational drugs, or a history of drug abuse or alcoholism within the past year.\n6. Plans to conceive during the study period, current pregnancy, or lactation.\n7. Known HIV-positive status.\n8. Known active hepatitis B or C infection.\n9. Evidence of active bleeding or hemorrhagic diathesis.\n10. Radiation therapy within 14 days prior to inclusion.\n11. Receipt of any anti-tumor treatments including:\n\n    * Surgery or tumor embolization within 14 days prior to the first OM-RCA-01 dose, or\n    * Chemotherapy, immunotherapy, biological therapy, investigational therapy, or endocrine therapy (except ongoing androgen deprivation therapy for prostate cancer) within 14 days or within two half-lives of the drug (whichever is longer) prior to the first OM-RCA-01 dose.\n12. Prior treatment with any FGFR-inhibiting or FGFR-blocking agents.",{"count":380,"type":21},58,[113,24],"One of the most relevant targets in the field of novel targeted anticancer therapy is the family of receptors to fibroblast growth factor receptors (FGFRs). FGFR1 is the main representative of the FGFR family.\n\nThe goal of this clinical trial is to learn if monoclonal anti-FGFR1 antibody (OM-RCA-01) works to treat metastatic cancers expressing FGFR1. It will also learn about the safety of drug OM-RCA-01. The main questions it aims to answer are:\n\n1. What medical problems do participants have when receiving drug OM-RCA-01?\n2. What dose of the drug should patients receive in the next studies?\n3. Does tumor growth slow down in patients receiving OM-RCA-01?\n\nAll patients in this study will receive the antibody treatment. The drug will be given through a vein (by IV infusion) every two weeks, for as long as the disease remains under control and the treatment is well tolerated.",[384,31,385,386,387],"Renal Cell Carcinoma Metastatic","Non-small Cell Lung Cancer Metastatic","Breast Cancer Metastatic","Head & Neck Cancer",[389,390,391,392,393,394,258,395,396,397],"metastatic cancer","resistance","monoclonal antibody","fibroblast growth factor receptor 1","OM-RCA-01","kidney cancer","head & neck cancer","lung cancer","breast cancer","2026-01-20",{"date":400,"type":42},"2026-01-21",{"date":402,"type":42},"2025-12-02",{"date":404,"type":21},"2027-01-01",{"name":406,"class":49},"Kidney Cancer Research Bureau",5,{"id":409,"slug":410,"hasResults":12,"nctId":411,"briefTitle":412,"officialTitle":413,"acronym":4,"eligibilityCriteria":414,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":415,"targetDuration":4,"studyType":22,"phases":417,"briefSummary":418,"conditions":419,"keywords":421,"overallStatus":67,"whyStopped":4,"lastUpdateSubmitDate":398,"lastUpdatePostDateStruct":425,"startDateStruct":427,"completionDateStruct":429,"leadSponsor":431,"locationsCount":50},"100464420","exercise-to-enhance-cardiovascular-health-among-black-prostate-cancer-patients-with-androgen-deprivation-therapy-100464420","NCT05327465","Exercise to Enhance Cardiovascular Health Among Black Prostate Cancer Patients With Androgen Deprivation Therapy","Exercise to Enhance Cardiovascular Health Among Black Prostate Cancer Patients With Androgen Deprivation Therapy: POWER Trial","Inclusion Criteria:\n\n* Patients must meet all criteria to be eligible, including travel to Dana-Farber Cancer Institute (DFCI) to collect research data to address the study question.\n* Over 18 years old; children under the age of 18 will be excluded due to the rarity of the disease\n* Histologically diagnosed of localized or metastatic prostate cancer\n* Have been receiving androgen deprivation therapy (ADT) (i.e., luteinizing hormone-releasing hormone \\[LHRH\\] agonist\u002Fantagonist and\u002For androgen receptor \\[AR\\] agonist\u002Fantagonist) for at least one month with a plan to continue ADT for at least 4 months at the time of recruitment\n* Self-identify as Black\n* Medically cleared to participate in exercise by their referred physician or a certified clinical exercise physiologist\n* Are without medical conditions that could exacerbate with exercise, such as bone disease (excluding bone metastases) at imminent risk of fracture or uncontrolled cardiopulmonary or metabolic diseases\n* Speak English and\u002For Spanish\n* Currently participate in less than or equal to 60 minutes of moderate or vigorous structured exercise\u002Fweek\n* Willing to travel to DFCI for necessary data collection\n* Ability to communicate and complete written forms in English and\u002For Spanish\n\nExclusion Criteria:\n\n* Are not receiving ADT (i.e., LHRH agonist\u002Fantagonist and\u002For AR agonist\u002Fantagonist)\n* Pre-existing medical conditions such as uncontrolled cardiopulmonary disease, or metabolic diseases that could exacerbate with exercise\n* Are not English or Spanish speaking\n* Patients with secondary diagnosis (with the exception of basal cell carcinoma)\n* Participate in more than 60 minutes of moderate or vigorous structured exercise\u002Fweek\n* Unable to travel to DFCI for necessary data collection\n* May not be able to comply with the safety monitoring requirements of the study in the opinion of the investigator.",{"count":416,"type":21},62,[61],"The purpose of this research is to determine whether a 16-week culturally tailored, technology-based, aerobic and resistance exercise intervention improves cardiovascular risk factors in Black men diagnosed with prostate cancer and are undergoing androgen deprivation therapy (ADT), and whether it will also improve physical fitness and function, body composition, and outcomes such as quality of life, cancer symptoms, and self-esteem.\n\nParticipants in this study will be randomly assigned to one of two groups: 1) Aerobic and resistance exercise, or 2) Usual care.",[420,27,31],"Androgen Deprivation Therapy",[422,423,31,424],"Androgen deprivation therapy","Localized Prostate Cancer","Exercise",{"date":426,"type":42},"2026-01-22",{"date":428,"type":42},"2022-08-11",{"date":430,"type":21},"2026-12-31",{"name":432,"class":49},"Dana-Farber Cancer Institute",{"id":434,"slug":435,"hasResults":12,"nctId":436,"briefTitle":437,"officialTitle":438,"acronym":439,"eligibilityCriteria":440,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":441,"targetDuration":4,"studyType":22,"phases":442,"briefSummary":443,"conditions":444,"keywords":445,"overallStatus":67,"whyStopped":4,"lastUpdateSubmitDate":448,"lastUpdatePostDateStruct":449,"startDateStruct":451,"completionDateStruct":452,"leadSponsor":454,"locationsCount":50},"100550705","dynamic-68ga-psma-and-18f-fdg-petct-analysis-prior-to-177lu-psma-100550705","NCT06450548","Dynamic 68Ga-PSMA and 18F-FDG PET\u002FCT Analysis Prior to 177Lu-PSMA","Dynamic 68Ga-PSMA and 18F-FDG PET\u002FCT Analysis of Metastatic Prostatic Adenocarcinomas Prior to 177Lu-PSMA Treatment","PYPET","Inclusion Criteria:\n\n* Signed informed consent.\n* Progressive metastatic castration-resistant prostate adenocarcinoma, which has been treated with taxane chemotherapy and at least one anti-androgen hormone therapy.\n* Evaluated by 18F-FDG and 68Ga-PSMA PET\u002FCT prior to potential treatment with 177Lu-PSMA.\n* Affiliated with or beneficiary of a social protection scheme.\n* WHO stage 0 or 1.\n\nExclusion Criteria:\n\n* Patients unable to understand the study for any reason or comply with the trial requirements (due to language barriers, psychological issues, geographical constraints, etc.).\n* Patients unable to undergo the examinations and\u002For maintain a prolonged lying position (due to back pain, etc.).",{"count":252,"type":21},[61],"Prostate cancer is a significant health issue, representing 21.8% of male cancer cases in France with over 449,000 new cases in 2018. It's the cause of 10% of cancer deaths in Europe.\n\nThe PSMA is a target for mCRPC treatment, with therapies like 177Lu-PSMA-617 delivering radiation to cancer cells. The Vision study showed that 177Lu-PSMA-617, combined with standard care, improved survival rates significantly compared to standard care alone.The French ANSM authorized 177Lu-PSMA-617 for mCRPC under certain conditions. Patients must have histologically confirmed mCRPC, be progressive despite treatment, and have PSMA-positive imaging.\n\nImaging assessments include PSMA PET\u002FCT and 18F-FDG PET\u002FCT to identify FDG-positive and PSMA-negative sites, which are associated with a poorer prognosis.\n\nParametric analysis using dynamic PET could improve lesion characterization, aiding in treatment decisions. This is the focus of the PyPET study.\n\nThe main objective focuses on a comparative analysis of data from dynamic parametric analysis (metabolic influx rate Ki, volume of distribution Vd) and static analysis (standard at 1 hour) using 18F-FDG and 68Ga-PSMA PET\u002FCT for diagnosing metastases, especially in the liver, lymph nodes, and bones. It aims to assess the effectiveness of these imaging techniques in accurately identifying metastatic sites.",[31],[258,446,447],"68GA-PSMA","parametric acquisition","2025-12-29",{"date":450,"type":42},"2026-01-02",{"date":269,"type":42},{"date":453,"type":21},"2028-03-05",{"name":455,"class":49},"Centre Henri Becquerel",{"id":457,"slug":458,"hasResults":12,"nctId":459,"briefTitle":460,"officialTitle":461,"acronym":462,"eligibilityCriteria":463,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":464,"targetDuration":4,"studyType":22,"phases":466,"briefSummary":467,"conditions":468,"keywords":469,"overallStatus":67,"whyStopped":4,"lastUpdateSubmitDate":472,"lastUpdatePostDateStruct":473,"startDateStruct":475,"completionDateStruct":477,"leadSponsor":479,"locationsCount":481},"100349754","phase-2-evaluation-of-response-to-abirateroneprednisone-by-raceethnicity-and-other-factors-in-metastatic-hormone-naive-prostate-cancer-100349754","NCT03833921","Evaluation of Response to Abiraterone\u002FPrednisone by Race\u002FEthnicity and Other Factors in Metastatic Hormone Naive Prostate Cancer","Evaluation of Response to Abiraterone\u002FPrednisone by Race\u002FEthnicity, PSA Decline and Genetic Variation in Proteins Involved in Androgen Metabolism in Metastatic Hormone Naive Prostate Cancer","APRE","Inclusion Criteria:\n\n* All patients must have a histologically or cytologically proven diagnosis of adenocarcinoma of the prostate. All patients must have metastatic disease as evidenced by soft tissue and\u002For bony metastases prior to initiation of androgen deprivation therapy (ADT). NOTE: ADT does not include treatment with anti-androgens such as bicalutamide or flutamide or five alpha reductase inhibitors such as finasteride or dutasteride.\n* Patients must have radiographic assessments of all disease including bone scan (or PET scan) within 42 days prior to registration. All disease will be assessed and documented on the appropriate CRF.\n* Patients must have had no more than 42 days of prior castration (medical or surgical) for metastatic prostate cancer prior to starting abiraterone. The start date of medical castration is considered the day the patient first received an injection of a LHRH agonist\u002Fantagonist (or orchiectomy), not an oral antiandrogen. • If the method of castration was luteinizing hormone releasing hormone (LHRH) agonist or antagonist (i.e., leuprolide, goserelin or degarelix), the patient must be willing to continue the use of LHRH agonist\u002Fantagonist and add Abiraterone + Prednisone treatment. • If the patient was on an antiandrogen (e.g. bicalutamide, flutamide), the patient must be willing to switch over to Abiraterone + Prednisone treatment. There is no limit on how many days a patient may have been on an antiandrogen (e.g. bicalutamide, flutamide) or a five alpha reductase inhibitor (e.g. finasteride or dutasteride) prior to going on study and no washout is required.\n* Patients may have received prior ADT - neoadjuvant and\u002For adjuvant setting only - but it must not have lasted for more than 36 months. Single or combination therapy allowed. At least 6 months must have elapsed since completion of ADT in the neoadjuvant and\u002For adjuvant setting, and serum testosterone must be \\> 50 ng\u002FdL (non-castrate levels) within 28 days prior to registration. NOTE: Serum testosterone assessment is required for eligibility for only those patients with prior treatment with neoadjuvant or adjuvant ADT.\n* Patients who are deemed to have high-risk or extensive metastatic, hormone sensitive prostate cancer (mHSPC) per \"clinical judgment\" of the treating physician are eligible for enrollment if the participants are unsuitable candidates for docetaxel or if the participants have declined docetaxel therapy.\n* Patients may have received prior surgery. For all major surgeries, at least 14 days must have elapsed since completion and patient must have recovered from all major side effects of surgery per investigator's assessment.\n* Patients may have received or plan to receive concurrent bone targeting agents that do not have an effect on PSA (e.g. denosumab or bisphosphonate).\n* Patients must have no plans to receive any other experimental therapy while on the protocol treatment. Previous experimental therapy must have been completed at least 28 days prior to registration.\n* Patients must have a complete physical examination and medical history within 28 days prior to registration.\n* Patients must have a PSA ≥ 10 ng\u002FmL obtained within 90 days prior to registration.\n* Patients must have a QTc interval \\< 461 msec on the 12 lead ECG within 42 days prior to registration. Patients with asymptomatic or incidental bundle branch blocks may have QTc measured by a cardiologist or standard formulas such as Bazett's or Fridericia's to adjust for pre-existing blocks.\n* Patients must have adequate hepatic function, within 28 days prior to registration, as evidenced by: • bilirubin ≤ 2 x institutional upper limit of normal (ULN), and • SGOT (AST) and SGPT (ALT) ≤ 3 x institutional ULN, or ≤ 5 x institutional ULN if liver metastases are present.\n* Patients must have adequate renal function, within 28 days prior to registration, as evidenced by calculated creatinine clearance ≥ 40 mL\u002Fmin using a serum creatinine or by 24-hour urine creatinine (using Cockroft-Gault equation).\n* Patients must have adequate hematologic function, within 28 days prior to registration as evidenced by:\n\n  * leukocytes ≥ 3,000\u002FmcL,\n  * absolute neutrophil count (ANC) ≥ 1,500\u002FmcL,\n  * hemoglobin ≥ 9 g\u002FdL, and\n  * platelets ≥ 100,000\u002FmcL.\n* Patients must have a Zubrod performance status of 0-2. Zubrod performance status 3 will be allowed if from bone pain only.\n* No other prior malignancy is allowed except for the following: adequately treated basal cell or squamous cell skin cancer, adequately treated Stage I or II cancer from which the patient is currently in complete remission, or any other cancer from which the patient has been disease-free for 5 years.\n* Patients must be ≥ 18 years of age.\n* Patients or their legally authorized representative must be informed of the investigational nature of this study and must sign and give written informed consent in accordance with institutional and federal guidelines.\n\nVoluntary written informed consent must be obtained before performance of any study-related procedure not part of normal medical care, with the understanding that consent may be withdrawn by the patient at any time without prejudice to future medical care.\n\nExclusion Criteria:\n\n* Patients with known brain metastases are not eligible. Brain imaging studies are not required for eligibility if the patient has no neurologic signs or symptoms suggestive of brain metastasis. But, if brain imaging studies are performed, patients must be negative for disease.\n* Patients must not have received prior and\u002For must not have any plans for receiving concomitant therapy with ketoconazole, aminoglutethimide, or enzalutamide (MDV3100). Concurrent megestrol for hot flashes is allowed.\n* Patients must not have received any prior cytotoxic chemotherapy for metastatic prostate cancer. Prior cytotoxic chemotherapy with curative intent in the neoadjuvant or adjuvant setting is allowed. At least 2 years must have elapsed since completion of cytotoxic chemotherapy in the neoadjuvant and\u002For adjuvant setting.\n* Patients must not have New York Heart Association Class III or IV heart failure at the time of screening. Patients must not have any thromboembolic event, unstable angina pectoris, myocardial infarction, or serious uncontrolled cardiac arrhythmia within 6 months prior to registration. (Note: Androgen deprivation therapy may prolong the QT\u002FQTc interval. Patients with congenital long AT syndrome, congestive heart failure, frequent electrolyte abnormalities, and patients taking drugs known to prolong the QT interval may be at increased risk.)\n* Patients with a known history of primary and secondary adrenal insufficiency are not eligible.\n* Patients must not be known to have hypersensitivity to abiraterone or to LHRH agonist\u002Fantagonist.\n* Patients must not have known gastrointestinal (GI) disease or GI procedure that could interfere with the GI absorption or tolerance of abiraterone, including difficulty swallowing oral medications per investigator's clinical judgement.",{"count":465,"type":21},130,[24],"The investigators are conducting this study with men that have prostate cancer and are getting standard of care treatment with the drugs abiraterone acetate and prednisone. The study will follow men with prostate cancer from initiation of participation in the study and for up to 10 years. The reason for the study is that researchers think that there may be a connection between the race and ethnicity of men with prostate cancer and how well the standard treatments work for the participants.",[31,27],[470,471],"Abiraterone acetate","hormone naive prostate cancer","2025-12-05",{"date":474,"type":42},"2025-12-11",{"date":476,"type":42},"2019-05-23",{"date":478,"type":21},"2038-04",{"name":480,"class":49},"Martha Mims",3,{"id":483,"slug":484,"hasResults":12,"nctId":485,"briefTitle":486,"officialTitle":487,"acronym":4,"eligibilityCriteria":488,"healthyVolunteers":12,"sex":109,"minAge":18,"maxAge":489,"enrollmentInfo":490,"targetDuration":4,"studyType":22,"phases":491,"briefSummary":492,"conditions":493,"keywords":494,"overallStatus":67,"whyStopped":4,"lastUpdateSubmitDate":496,"lastUpdatePostDateStruct":497,"startDateStruct":499,"completionDateStruct":501,"leadSponsor":503,"locationsCount":50},"100528786","exercise-in-prostate-cancer-100528786","NCT06165302","Exercise in Prostate Cancer","EPC Trial: Exercise in Prostate Cancer","Inclusion Criteria:\n\n1. Men with metastatic prostate adenocarcinoma\n2. Currently taking androgen deprivation therapy alone or with an oral androgen axis inhibitor (abiraterone, enzalutamide, darolutamide, or apalutamide are permitted) and have been on treatment for at least 3 months\n3. Elevated (PSA \\> 1ng\u002FmL) or rising PSA (any numerical increase based on at least 2 PSA readings at least 2 weeks apart)\n4. Any number of prior therapies (prior chemo, radium-223, etc.) is allowed\n5. CTC + according to standard clinical grade laboratory test by androgen receptor isoform splice variant 7 (AR-V7) testing at Hopkins.\n6. If a bone protective agent is to be started, it should be started at least 2 weeks prior to the onset of exercise intervention.\n7. Eastern Cooperative Oncology Group (ECOG) performance status \\\u003C=1\n8. Clearance by cardiologist if under the current care of a cardiologist (seen in the past 1 year)\n9. Age \\\u003C=80 years\n\nExclusion Criteria:\n\n1. Small cell carcinoma of the prostate\n2. Unable to participate or monitor exercise compliance due to conditions such as impaired cognition\n3. Moderate to severe bone pain that limits any activities of daily living, including use of narcotics for prostate cancer related pain\n4. Clinical progression requiring a change in systemic therapy or the addition of palliative radiation for symptom control\n5. Bone metastases in spine or long bones which, in the eye of the treating physician require referral to radiation oncology or surgery for management due to risk of fracture\n6. Significant cardiovascular disease or concurrent illness that would make exercise intervention for 12 weeks unsafe. If there is significant cardiovascular disease and the participant is under the care of a cardiologist (seen within the past 1 year), approval of the cardiologist to participate is required.\n7. Major surgery within the past 4 weeks","80 Years",{"count":20,"type":21},[61],"The goal of this clinical trial is to learn how exercise intervention affects circulating tumor cells (CTC) in men with advanced prostate cancer. The primary objective is to determine if an exercise intervention decreases CTCs in men with advanced prostate cancer. Participants will have baseline screening assessments, followed by 12 weeks of exercise intervention, and then follow-up assessments 12 weeks after the end of the exercise intervention.",[31,27],[495],"Exercise Intervention","2025-10-15",{"date":498,"type":42},"2025-10-20",{"date":500,"type":42},"2025-10-16",{"date":502,"type":21},"2030-01-30",{"name":76,"class":49},{"id":505,"slug":506,"hasResults":12,"nctId":507,"briefTitle":508,"officialTitle":509,"acronym":510,"eligibilityCriteria":511,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":512,"targetDuration":4,"studyType":86,"phases":4,"briefSummary":514,"conditions":515,"keywords":518,"overallStatus":67,"whyStopped":4,"lastUpdateSubmitDate":522,"lastUpdatePostDateStruct":523,"startDateStruct":524,"completionDateStruct":526,"leadSponsor":528,"locationsCount":481},"100526995","arctic-liquid-biomarkers-in-the-prospective-androgen-receptor-signaling-inhibitors-arsi-resistance-clinical-trials-100526995","NCT06141993","ARCTIC: Liquid Biomarkers in the Prospective Androgen Receptor Signaling Inhibitors (ARSI) Resistance Clinical Trials","Clinical Validation of a Circulating Tumor Cell AR Therapy Resistance Assay in Men With Metastatic Castration Resistant Prostate Cancer (ARCTIC)","ARCTIC","Inclusion Criteria:\n\nPatients will be eligible for inclusion in this study only if all of the following criteria apply:\n\n1. Histologically confirmed diagnosis of adenocarcinoma of the prostate. Patients with pure small cell\u002Fneuroendocrine tumors of the prostate are not permitted.\n2. Radiographic evidence of metastatic disease by CT, MRI, or PET imaging.\n3. Prior documented disease progression on one potent AR inhibitor (darolutamide, abiraterone, enzalutamide, or apalutamide or combinations of these) in any disease setting (mHSPC, nmCRPC, mCRPC) based on sequential PSA rises or radiographic progression.\n4. Planned therapy with either standard of care enzalutamide and\u002For abiraterone acetate or another potent AR inhibitor (darolutamide, apalutamide if available) within the coming 6 weeks\n5. Castrate levels of testosterone (\\\u003C50 ng\u002Fdl) at most recent assessment and\u002For documented ongoing Androgen Deprivation Therapy.\n6. Evidence of disease progression based on a rising PSA on or following most recent therapy as evidenced by the following:\n\n   1. Consecutive PSA rises at least 2 weeks apart\n   2. Minimum PSA of 1.0 ng\u002Fdl prior to entry\n7. Age \\> 18 years.\n8. Ability to understand and the willingness to sign a written informed consent document.\n\nExclusion Criteria:\n\nA patient will not be eligible for inclusion in this study if any of the following criteria apply:\n\n1. History of intercurrent or past medical or psychiatric illness including active stage IV malignancy that would make participation in a blood drawing protocol difficult or not feasible at the discretion of the principal investigator or co-investigator(s).\n2. Unwillingness to be followed longitudinally for serial CTC biomarker studies.\n3. Life expectancy \\\u003C 6 months\n4. Planned combination therapy with radiation or other systemic therapies other than ADT and bone health agents.",{"count":513,"type":21},120,"This study will follow men with metastatic castration resistant prostate cancer throughout their standard of care treatment for their disease to determine if the presence of different genes or proteins can predict which patients respond to the cancer treatment they receive. As tumors grow and begin to spread, they may release cells into patients' bloodstream. These cells are called \"circulating tumor cells\", or CTCs. CTCs can be used to look for differences in \"biomarkers\" (genes or proteins that may change based on how a person is or is not responding to treatment). The purpose of this research study is to learn whether scientists can use biomarkers from CTCs to predict which tumors will respond to certain hormonal therapies. Participants will have blood collected and provide an archival sample from a previous tumor biopsy. The researchers will compare biomarkers from participants who responded well to treatment to those who responded poorly in order to answer the research question.",[27,516,31,517],"Prostate Adenocarcinoma","Castration-resistant Prostate Cancer",[519,520,521],"Circulating Tumor Cells (CTC)","Androgen-receptor signaling inhibitors (ARSI)","Metastatic castration resistant prostate cancer (mCRPC)","2025-10-13",{"date":496,"type":42},{"date":525,"type":42},"2024-05-13",{"date":527,"type":21},"2027-04",{"name":529,"class":49},"Duke University",{"id":531,"slug":532,"hasResults":12,"nctId":533,"briefTitle":534,"officialTitle":535,"acronym":536,"eligibilityCriteria":537,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":538,"targetDuration":4,"studyType":22,"phases":540,"briefSummary":541,"conditions":542,"keywords":543,"overallStatus":67,"whyStopped":4,"lastUpdateSubmitDate":547,"lastUpdatePostDateStruct":548,"startDateStruct":550,"completionDateStruct":552,"leadSponsor":554,"locationsCount":556},"100540686","phase-3-a-randomised-controlled-platform-trial-testing-treatments-in-metastatic-hormone-sensitive-prostate-cancer-100540686","NCT06320067","A Randomised Controlled Platform Trial Testing Treatments in Metastatic Hormone Sensitive Prostate Cancer","Studying Treatments in Patients Receiving Androgen Deprivation Therapy (ADT) for Metastatic Prostate Cancer: Evaluation of Drug and Radiation Efficacy: A 2nd Multi-arm Multi-stage Randomised Controlled Trial (STAMPEDE2).","STAMPEDE2","Registration Inclusion Criteria:\n\n1. At least 18 years old.\n2. Histological confirmation of prostate adenocarcinoma or a strong clinical suspicion of prostate cancer with a plan to confirm the diagnosis formally before any future randomisation.\n3. Confirmation of metastatic site(s) on CT\u002FMRI and either bone or PET scan. Patients with metastatic disease meeting any of the following criteria are eligible:\n\n   * Metastatic disease to the bone (in any distribution).\n   * Non-regional lymph node metastases of any size or distribution. Lymph nodes that are only visible on PET will not be eligible as sites of metastasis. Note: If lymph nodes are the only site of metastases, then at least one must be at least 1.5cm in short axis AND outside of the pelvis.\n   * Visceral metastases of any size or distribution.\n4. Clinical presentation is:\n\n   A. de novo. OR B. relapsed with; (1) continuing hormone sensitivity in the opinion of the investigator, and; (2) all hormone treatments (e.g., ADT and ARPI) will have been completed ≥2 years prior to any future randomisation into any of the comparisons, and; (3) will have received ≤3 years total of ADT at the point of randomisation into any comparison.\n\n   Note: the dates will be checked again at randomisation. It is the responsibility of the investigator to account for the time between registration and randomisation into any comparison.\n5. Long-term androgen deprivation therapy (ADT) has started or there is an intention to start for a minimum of 2 years.\n6. WHO Performance Status 0-2 or, if WHO Performance Status 3, deemed to be due to metastatic burden and expected to improve with ADT. Note: Improvement to WHO status 0-2 will be checked again at randomisation into any subsequent comparison.\n\n   Note: For WHO performance status definitions see Appendix 1.\n7. Willing and able to comply with trial treatments.\n8. Patient has signed informed consent form for registration into the STAMPEDE2 Trial platform.\n\nRegistration Exclusion Criteria:\n\n1. Clinically and pathologically overt small cell carcinoma.\n2. Metastatic brain disease or leptomeningeal disease.\n3. Any active malignancies (i.e., progressing or requiring any treatment in the previous 36 months) other than prostate cancer (except non-muscle invasive bladder cancer; nonmelanomatous skin cancer or a malignancy that is considered cured with minimal risk of recurrence).\n4. Any other medical condition that in the investigator's opinion means the participant is unfit or unsuitable for long-term ADT or the trial treatments in the comparison for which they are being considered.\n\nEligibility Criteria For Comparison S Testing SABR:\n\nPatients who meet the general eligibility criteria can be considered for the SABR comparison. Recruiting sites will assess metastatic disease burden using CT\u002FMRI scans and baseline Tc-99m bone scan or PET scan to assess number of metastatic bone and non-regional lymph node foci, and presence of visceral metastases. Patients will be classified as either 'SABR-eligible' or 'SABR-ineligible' using the following definition.\n\nDefinition of SABR-eligible disease:\n\nPatients will be classified as SABR-eligible if they meet all the following criteria:\n\n* 1-5 metastatic lesions (including either bone and\u002For non-regional lymph node sites).\n* Clinician determination that metastatic lesions are considered suitable for SABR on technical grounds (such as proximity of dose limiting normal tissue or tumour volume). Note: Clinical determination can consider next-generation imaging (e.g., PSMA PET-CT or WBMRI) where available. It is the investigator's responsibility to consider the impact of any findings on the suitability of SABR for the patient. Any next-generation imaging used prior to randomisation should be declared at randomisation so that it can be used as a stratification factor.\n* Absence of visceral metastases.\n\nOtherwise, patients will be classified as SABR-ineligible.\n\nIn addition to the general registration eligibility criteria, they need to meet all the following criteria for entry into Comparison S:\n\n1. Patient still meets all eligibility criteria for registration in Section 4.4.\n2. Histological confirmation of prostate adenocarcinoma.\n3. Newly diagnosed (de novo) metastatic disease that is considered eligible for SABR according to the above definition.\n4. Patient has started ADT and randomisation is ≤12 weeks since the start of ADT.\n5. WHO performance status 0-2 (see Appendix 1).\n6. Patient has provided signed informed consent for participation in Comparison S.\n\nExclusion Criteria For Comparison S Testing SABR:\n\n1. Patient has relapsed prostate cancer.\n2. Prior radical treatment to the prostate (e.g., radical surgery and\u002For radiotherapy).\n3. Intracranial metastatic disease.\n4. Prior treatment to a metastatic site (e.g., radiotherapy, surgery or RFA).\n5. Significant or progressive neurological deficit such that emergency (within 24 hours) surgery or radiation required (e.g., metastatic spinal cord compression, or impingement of the cord or any other clinical scenario whereby urgent radiotherapy to the spine is required).\n6. Any condition or co-morbidities that, in the judgement of the clinician, preclude procedures required to facilitate radiotherapy delivery e.g.:\n\n   1. Disease staging and follow-up.\n   2. Radiotherapy planning procedures.\n7. Any condition or co-morbidities that, in the judgement of the clinician, preclude the safe delivery of radiotherapy to the prostate (± pelvic lymph nodes) and\u002For metastases e.g., inflammatory bowel disease, significant systemic connective tissue disorder, radiological evidence of idiopathic pulmonary fibrosis).\n8. Active malignancy other than prostate cancer within the last 36 months.\n\nEligibility Criteria For Comparison P Testing 177LU-PSMA-617:\n\nIn addition to the general eligibility criteria, patients need to meet the following criteria for entry into Comparison P:\n\n1. Patient still meets all eligibility criteria for registration.\n2. Histological confirmation of prostate adenocarcinoma.\n3. Patient meets the definition of SABR ineligible disease.\n4. Patients must have adequate organ function as indicated by blood tests within 4 weeks prior to randomisation:\n\n   Bone marrow function\n   1. ANC ≥1.5 x 109\u002FL\n   2. Platelets ≥100 x 109\u002FL\n   3. Haemoglobin ≥9g\u002FdL, independent of transfusions for at least 28 days Hepatic function\n\n   \u003C!-- -->\n\n   1. Total bilirubin ≤2 x ULN. For patients with Gilbert's Syndrome ≤3 x ULN is permitted.\n   2. AST and\u002For ALT performed with all results ≤3 × ULN or ≤5 x ULN for patients with liver metastasis Renal Function\n\n   \u003C!-- -->\n\n   1. EGFR ≥50 mL\u002Fmin\u002F1.73m2 calculated using the MDRD formula\n   2. Albumin ≥25g\u002FL\n5. Patient has started ADT and randomisation is ≤12 weeks since start of current ADT.\n6. If relapsed disease, prior LHRH agonist\u002Fantagonist with or without first generation antiandrogen use in the adjuvant\u002Fneo-adjuvant setting, hormone treatment must have been discontinued ≥2 years prior to randomisation AND must not have exceeded a total of \\>3 years of therapy AND must not have shown disease progression within 12 months of completing adjuvant\u002Fneo-adjuvant therapy.\n7. WHO performance status 0-2 (see Appendix 1).\n8. Patient has provided signed informed consent for participation in Comparison P.\n\nExclusion Criteria For Comparison P Testing 177Lu-PSMA-617:\n\n1. Prior treatment with any of the following:\n\n   1. Strontium-89, Samarium-153, Rhenium-186, Rhenium-188, Radium-223\n   2. PSMA-targeted radioligand therapy\n2. Symptomatic cord compression, or clinical\u002Fradiological findings indicative of impending cord compression.\n3. Any condition that precludes raised arms position.\n4. Unmanageable bladder outflow obstruction or urinary incontinence. Note: bladder outflow obstruction or urinary incontinence which is manageable and controlled with best available standard of care (incl. drainage, pads) is permitted.\n5. Imaging Sub-study only: Contraindication to MRI (e.g., pacemakers, except MRI compatible pacemakers).",{"count":539,"type":21},3360,[144],"STAMPEDE2 is a clinical trial comparing two new treatments with standard of care in people with prostate cancer that has spread to other parts of the body and is responsive to hormone therapy. People from all backgrounds and ethnicities are encouraged to take part and multiple hospitals across the UK are involved. University College London is running the trial.\n\nEach comparison within the trial has its own control arm where people get the best standard of care (Arm A) versus a research arm where a new treatment is added to standard of care.\n\nParticipants are allocated to an arm by a computerised system with a 50% chance of getting the research treatment.\n\nComparison S: Arm A versus Arm S (Stereotactic Ablative Body Radiotherapy (SABR)) - Tests whether giving targeted doses of radiotherapy (SABR) to parts of the body where the cancer has spread slows the spread of the cancer and improves survival. 2476 people will be in this comparison.\n\nComparison P: Arm A versus Arm P (PSMA-Lutetium (177Lu-PSMA-617)) - Tests whether giving a radioactive material (177Lu-PSMA-617) that targets prostate cancer cells slows the spread of the cancer and improves survival. 1756 people will be in this comparison.\n\nAll participants will be followed up with scans and tests to monitor their cancer. Doctors will check for any side effects from the treatments. Treatments will be stopped if side effects are serious, or people no longer wish to take the treatments.",[31],[544,545,546],"Hormone sensitive metastatic prostate cancer","Stereotactic ablative body radiotherapy (SABR)","PSMA-Lutetium","2025-09-22",{"date":549,"type":42},"2025-09-26",{"date":551,"type":42},"2024-06-11",{"date":553,"type":21},"2032-03",{"name":555,"class":49},"University College, London",18,{"id":558,"slug":559,"hasResults":12,"nctId":560,"briefTitle":561,"officialTitle":562,"acronym":4,"eligibilityCriteria":563,"healthyVolunteers":12,"sex":17,"minAge":564,"maxAge":4,"enrollmentInfo":565,"targetDuration":4,"studyType":86,"phases":4,"briefSummary":566,"conditions":567,"keywords":4,"overallStatus":67,"whyStopped":4,"lastUpdateSubmitDate":568,"lastUpdatePostDateStruct":569,"startDateStruct":571,"completionDateStruct":573,"leadSponsor":575,"locationsCount":50},"100532646","geriatric-assessment-and-technology-evaluation-in-prostate-cancer-100532646","NCT06215508","Geriatric Assessment and Technology Evaluation in Prostate Cancer","Prostate Cancer Geriatric Assessment and Technology Evaluation (ProsGATE) Study","Inclusion Criteria:\n\n* Patients must have histologically or cytologically confirmed adenocarcinoma of prostatic origin without neuroendocrine differentiation or signet ring or small-cell histologic features.\n* Patients must be metastatic by having at least one metastatic lesion seen at the time of diagnosis or upon initiation of treatment on bone scan or computed tomography (CT) or magnetic resonance imaging (MRI), or by next-generation molecular imaging (FDG, F-18 sodium fluoride (NaF), C-11 choline, F-18 Fluciclovine, Ga-68 Prostate-specific membrane antigen (PSMA-11) positron emission tomography\u002Fcomputed tomography or magnetic resonance imaging.\n* Age ≥ 65years. positron emission tomography the aforementioned GA tools are only validated in those aged 65 and older.\n* Planned initiation of intensified hormone deprivation (ADT and ARSI)\n* Ability to understand and the willingness to sign a written informed consent document.\n\nExclusion Criteria:\n\n* Participants with previous exposure to ADT\u002FARSI within 12 months of diagnosis, except those who initiated ADT\u002FARSI within 12 weeks of enrollment.\n* Participants who had surgical orchiectomy outside of 12 weeks before their metastatic diagnosis.\n* Participants who have had previous chemotherapy for metastatic prostate cancer.\n* Uncontrolled intercurrent illness. \"Uncontrolled intercurrent illness\" refers to a concurrent medical condition that is not adequately managed or stable at the time of enrollment. This could be any illness, disorder, or medical issue occurring alongside the primary disease being treated or studied, and its lack of control poses additional risk to the patient or complicates the management of the primary condition. For example, in the context of enrolling patients in a clinical trial for a cancer treatment, a patient with uncontrolled diabetes mellitus or hypertension would be considered to have an uncontrolled intercurrent illness as diabetes and hypertension - if poorly managed - can lead complications that could interfere with the patient's ability to safely participate in the trial, potentially confounding the study results or posing additional health risks to the patient.\n* Participants with small-cell carcinoma of the prostate or brain metastasis.\n* Participants who are not fluent in reading\u002Fwriting English or Spanish.\n* Biologic and Pregnant women are excluded from this study because prostate cancer is a disease of biological males.\n* Participants with implantable cardiac devices.\n* Participants with limb defects precluding smart-watch wear.","18 Minutes",{"count":513,"type":21},"By doing this study, doctors hope to learn more about factors that contribute to frailty (a condition where older adults feel weak, get tired easily, and struggle more with everyday activities) and serious side effects among men over the age of 65 who will receive androgen deprivation therapy (also called \"hormone therapy\") for prostate cancer that has spread to other parts of their body. Participation in this research will last about 5 years. For the first year, participants will have 5 study visits where they have give blood samples, answer survey questions, and use a wearable device. After study visits are complete, there is a 4-year follow-up period. Research team will check regular doctor visits and look at participants' medical records.",[27,31],"2025-06-06",{"date":570,"type":42},"2025-06-08",{"date":572,"type":21},"2026-04",{"date":574,"type":21},"2031-04",{"name":576,"class":49},"University of Chicago",{"id":578,"slug":579,"hasResults":12,"nctId":580,"briefTitle":581,"officialTitle":582,"acronym":4,"eligibilityCriteria":583,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":584,"targetDuration":4,"studyType":22,"phases":585,"briefSummary":586,"conditions":587,"keywords":591,"overallStatus":67,"whyStopped":4,"lastUpdateSubmitDate":597,"lastUpdatePostDateStruct":598,"startDateStruct":600,"completionDateStruct":602,"leadSponsor":604,"locationsCount":50},"100590838","phase-2-treatment-of-patients-with-progressive-mcrpc-with-177lu-psma-617-100590838","NCT06972628","Treatment of Patients With Progressive mCRPC With 177Lu-PSMA-617","177Lu-PSMA-617 (Pluvicto) for the Treatment of Patients With Progressive PSMA-Positive Metastatic Castration-Resistant Prostate Cancer (mCRPC) and Super Scan Bone Scan","Inclusion Criteria:\n\n1. Ability to understand and sign an informed consent form (ICF).\n2. Willingness and ability to comply with study requirements.\n3. Age ≥18 years.\n4. Presence of skeletal metastases with a superscan pattern on a 99mTc-MDP\u002FHDP bone scan, defined by significantly increased skeletal radioisotope uptake relative to soft tissues and faint or absent renal activity.\n5. Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2.\n6. Hemoglobin ≥9.0 g\u002FdL.\n7. Platelet count ≥90 × 10⁹\u002FL.\n8. White blood cell count ≥2.0 × 10⁹\u002FL, absolute neutrophil count (ANC) \\>1.5 × 10⁹\u002FL.\n\n   o These hematologic criteria must be met without recent transfusions (within 28 days prior to the first study treatment) or growth factor support (within 21 days).\n9. Serum\u002Fplasma creatinine ≤1.5 × upper limit of normal (ULN).\n10. Histological, pathological, or cytological confirmation of prostate cancer.\n11. Positive PSMA PET\u002FCT scan showing at least one PSMA-positive metastatic lesion.\n12. Castrate-level serum\u002Fplasma testosterone (\\\u003C50 ng\u002FdL or \\\u003C1.7 nmol\u002FL).\n13. Prior treatment with at least one androgen receptor-axis-targeted therapy (ARAT).\n\nExclusion Criteria:\n\n1. Prior treatment with radiopharmaceuticals (e.g., Strontium-89, Samarium-153, Rhenium- 186, Rhenium-188, Radium-223, hemi-body irradiation) within six months before start of treatment under this protocol.\n2. Prior PSMA-targeted radioligand therapy.\n3. Systemic anti-cancer therapy (e.g., chemotherapy, immunotherapy, monoclonal antibodies) within four weeks before screening visit.\n4. Known hypersensitivity to PLUVICTO or its components.\n5. Concurrent treatment with other cytotoxic chemotherapy, immunotherapy, radioligand therapy, or investigational therapy.\n6. Renal impairment (estimated glomerular filtration rate \\\u003C60 mL\u002Fmin), hemoglobin \\\u003C9 g\u002FdL, ANC \\\u003C1.5 × 10⁹\u002FL, or platelets \\\u003C 90 × 10⁹\u002FL.\n7. History of CNS metastases unless treated and stable for 6 months, with no ongoing corticosteroid use.\n8. Symptomatic or impending spinal cord compression.\n9. Other malignancies impacting life expectancy or interfering with study assessments. Exceptions include non-melanoma skin cancer or superficial bladder cancer that has been adequately treated.\n10. Major surgery within 30 days prior to enrollment.\n11. Plans to conceive or father a child during treatment and up to six months post-treatment.",{"count":85,"type":21},[24],"The purpose of this study is to evaluate the safety and tolerability of Lutetium-177-PSMA-617 (PLUVICTO) in patients with metastatic castration-resistant prostate cancer (mCRPC) and extensive bone metastases, which appear as a \"super scan\" pattern on a bone scan.\n\nPluvicto is FDA-approved, but patients with super scan bone scans were previously excluded from the VISION clinical trial, leaving a knowledge gap.\n\nThe study will enroll up to 30 men with metastatic castration-resistant prostate cancer, with an initial dosing approach that differs from the standard dose.\n\nThe safety and tolerability of PLUVICTO will be evaluated in this study, with a focus on identifying the optimal dose for this population.\n\nThis study addresses an important gap in understanding how Pluvicto performs in mCRPC patients with super scan findings.",[588,589,590,27,31],"Metastatic Castration-Resistant Prostate Cancer","Prostate Cancer Patients With Bone Metastasis","Prostate Cancer (CRPC)",[592,593,594,595,33,596],"Metastatic Castration-Resistant Prostate Cancer (mCRPC)","super scan bone scan","Prostate Cancer patients with bone metastasis","prostate cancer (CRPC)","Prostate cancer metastatic","2025-05-12",{"date":599,"type":42},"2025-05-15",{"date":601,"type":21},"2025-05-23",{"date":603,"type":21},"2029-04-01",{"name":605,"class":49},"Ebrahim S Delpassand",{"id":607,"slug":608,"hasResults":12,"nctId":609,"briefTitle":610,"officialTitle":611,"acronym":612,"eligibilityCriteria":613,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":614,"targetDuration":4,"studyType":22,"phases":616,"briefSummary":617,"conditions":618,"keywords":4,"overallStatus":67,"whyStopped":4,"lastUpdateSubmitDate":620,"lastUpdatePostDateStruct":621,"startDateStruct":623,"completionDateStruct":625,"leadSponsor":627,"locationsCount":50},"100439325","dutch-national-randomized-study-psma-petct-as-a-triage-tool-for-pelvic-lymph-node-dissection-in-prostatectomy-patients-100439325","NCT05000827","Dutch National Randomized Study: PSMA-PET\u002FCT As a Triage Tool for Pelvic Lymph Node Dissection in Prostatectomy Patients","Multi-institutional Evaluation of the Cost-effectiveness of PSMA-PET\u002FCT for the Detection of Pelvic Lymph Node Invasion in Newly Diagnosed Prostate Cancer Patients","PSMA-SELECT","Inclusion Criteria:\n\n* Biopsy proven adenocarcinoma of the prostate\n* Indication for ePLND combined with robot assisted radical prostatectomy (RARP) (MSKCC nomogram \\>5%, if not applicable when only MRI targeted biopsies are positive, the Briganti nomogram will be used)\n* Suitable for robot-assisted ePLND and RARP\n* Mentally competent and understanding of benefits and potential burden of the study\n* Written informed consent\n* No known allergies for PSMA tracer.\n\nExclusion Criteria:\n\n* History of prior diagnosed or treated PCa\n* Known concomitant malignancies (except Basal Cell Carcinoma of the skin)\n* Unwillingness or inability to undergo PSMA PET\u002FCT and\u002For ePLND and RARP\n* PSMA non-avid PCa (local tumor activity)\n* Presence of distant metastasis (M1)",{"count":615,"type":21},706,[61],"To determine if the use of Prostate-Specific Membrane Antigen Positron Emission Computer Tomography (PSMA PET\u002FCT) as a selection tool for performing extended lymph node dissection (ePLND) for prostate cancer (PCa) in the primary staging setting results in fewer ePLND procedures and therefore lower overall healthcare costs, lower patient burden in terms of intervention-related complications and morbidity, with comparable disease prognosis, compared to the current European Guideline-recommended standard practice which includes performing ePLND in PCa patients who are candidates for active treatment with a nomogram-calculated lymph node involvement (LNI) risk \\>5%.",[31,27,619],"Lymph Node Metastases","2025-02-19",{"date":622,"type":42},"2025-02-21",{"date":624,"type":42},"2021-07-28",{"date":626,"type":21},"2026-08-31",{"name":628,"class":49},"Canisius-Wilhelmina Hospital",{"id":630,"slug":631,"hasResults":12,"nctId":632,"briefTitle":633,"officialTitle":634,"acronym":635,"eligibilityCriteria":636,"healthyVolunteers":12,"sex":109,"minAge":18,"maxAge":4,"enrollmentInfo":637,"targetDuration":4,"studyType":86,"phases":4,"briefSummary":638,"conditions":639,"keywords":644,"overallStatus":67,"whyStopped":4,"lastUpdateSubmitDate":651,"lastUpdatePostDateStruct":652,"startDateStruct":653,"completionDateStruct":655,"leadSponsor":657,"locationsCount":50},"100534691","clinical-application-of-the-j-pet-scanner-prototype-100534691","NCT06242119","Clinical Application of the J-PET Scanner Prototype","Clinical Use of a J-PET Scanner Prototype Made of Plastic Scintilators","JPET2Clinic","Inclusion Criteria:\n\n* The patient is referred for a PET\u002FCT scan, in accordance with recognized indications for examining the entire body.\n* Age over 18 years\n* Informed, voluntary consent to participate in the study\n\nExclusion Criteria:\n\n* Pregnant women, breastfeeding women\n* People with a previously diagnosed allergy to radiopharmaceuticals\n* Age under 18 years\n* Lack of cooperation with the patient\n* Lack of informed consent to participate in the study",{"count":7,"type":21},"Positron emission tomography (PET), an advanced diagnostic imaging technique, exploits the annihilation of positrons (e+) to delineate pathological alterations within diseased tissues. Integral to PET scanners are detector systems that transform gamma photons into fluorescent photons, thereby gleaning insights into the energy, time, and spatial distribution of gamma photons emanating from positron-emitting radiopharmaceuticals. Conventional PET scanners, bear a significant financial burden primarily due to their reliance on LSO (lutetium oxyorthosilicate) or LYSO (lutetium yttrium oxyorthosilicate) scintillation crystals. The exorbitant cost and limited availability of these crystal scintillators impede the widespread adoption of PET scanners. In a departure from conventional PET technology, the prototype J-PET scanner employed in this trial employs plastic scintillators, characterized by unique physical properties. This prototype is further equipped with bespoke software enabling three-photon imaging based on the annihilation of ortho-positronium (o-Ps) generated within diseased tissue. This study delves into the clinical applicability of PET scanners employing plastic scintillators, particularly investigating the feasibility of PET imaging using plastic scintillators where gamma quanta interact by mechanisms other than the photoelectric effect. Furthermore, this study endeavors to contemporaneously acquire and analyze data related to the lifetime of ortho-positronium (o-P) atoms emanating from routine radiopharmaceuticals. Additionally, it seeks to validate the utilization of a novel diagnostic indicator, termed the \\"positron biomarker,\\" through a prospective study, comparing its efficacy to conventional diagnostic PET scanning methodologies.",[27,640,641,31,642,643],"Prostatic Hyperplasia","Prostatic Neoplasms","Neuroendocrine Tumors","Neuroendocrine Carcinoma",[645,646,647,648,649,650],"positronium","PET","[18F]FDG","[18F]choline","[68Ga]Ga-DOTA-TATE","[68Ga]Ga-PSMA","2025-02-17",{"date":620,"type":42},{"date":654,"type":42},"2024-03-07",{"date":656,"type":21},"2025-10-30",{"name":658,"class":49},"Jagiellonian University",{"id":660,"slug":661,"hasResults":12,"nctId":662,"briefTitle":663,"officialTitle":664,"acronym":4,"eligibilityCriteria":665,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":489,"enrollmentInfo":666,"targetDuration":4,"studyType":22,"phases":668,"briefSummary":669,"conditions":670,"keywords":671,"overallStatus":67,"whyStopped":4,"lastUpdateSubmitDate":677,"lastUpdatePostDateStruct":678,"startDateStruct":680,"completionDateStruct":682,"leadSponsor":684,"locationsCount":7},"100554245","phase-3-standard-of-care---177lu-psma-617-in-de-novo-mhspc-patients-with-poor-psa-response-peace6-poor-responders-100554245","NCT06496581","Standard of Care +\u002F- 177Lu-PSMA-617 In de Novo mHSPC Patients With Poor PSA Response (PEACE6-Poor Responders)","A Randomized Phase III Trial Evaluating the Efficacy and Safety of Standard of Care +\u002F- 177Lu-PSMA617 in de Novo Metastatic Hormone-sensitive Prostate Cancer Patients Having a PSA≥0.2 ng\u002FmL at 6-8 Months After Systemic Treatment Initiation","Inclusion Criteria:\n\nAll of the following criteria must be met ahead of randomization to satisfy trial eligibility requirements:\n\n1. Signed a written informed consent form prior to any trial specific procedures.\n\n   Note: In case of physical incapacitation, a trusted representative of their choice, which is not the Investigator or sponsor, can sign on the behalf of the patients.\n2. Aged ≥18 years old\n3. Life expectancy \\> 6 months as per investigator estimate\n4. Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2\n5. Men with histologically or cytologically confirmed adenocarcinoma of the prostate\n6. De novo metastatic disease defined by clinical or radiographic evidence of metastases at diagnosis (i.e. before any treatment started). If not available, a more recent imaging can be used\n7. Measurable disease or bone lesions evaluable according to PCWG3 criteria. Patients with doubtful bone metastases are not eligible\n8. A pre-randomization 68Ga-PSMA-11 PET\u002FCT scan performed within 4 weeks prior to randomization in the trial.\n\n   FDG PET scan is not required for this protocol. All patients will be treated independently from the results of pre-randomization PSMA PET scan: patients with PSMA-positive or PSMA-negative disease according to PROMISE 2.0 criteria are eligible.\n9. Have 6 to 8 months of previous AND ongoing standard systemic treatment for prostate cancer consisting in either:\n\n   * ADT with an androgen receptor signaling inhibitor (ARSI) (i.e., abiraterone (plus prednisone), or apalutamide or enzalutamide) ± radiotherapy \\*\\*\n   * ADT with docetaxel\\* plus an ARSI (i.e. abiraterone (plus prednisone), or darolutamide,) ± radiotherapy\\*\\*\n\n   Note:\n\n   \\*Docetaxel must have been stopped at least 4 weeks ahead of randomization.\n\n   \\*\\* Previous radiotherapy to the primary tumor and\u002For to the metastases is accepted as long as it was not PSMA-based and must has been completed at least 4 weeks ahead of randomization.\n10. Stable or declining PSA level but not a rising one\n11. Serum PSA of ≥ 0.2 ng\u002FmL at 6 to 8 months after systemic treatment initiation\n12. Testosterone level \\\u003C 50 ng\u002Fdl or \\\u003C 1.7 nmol\u002FL\n13. Be fit enough for 177Lu-vipivotide tetraxetan treatment:\n\n    * Adequate bone marrow function: hemoglobin ≥90 g\u002FL (in absence of red blood cell transfusion within 4 weeks prior to randomization), absolute neutrophil count ≥1.5 x10⁹\u002FL, platelet count \\>100 x10⁹\u002FL\n    * Adequate liver function: aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤2.0 x upper limit of normal (ULN), or ≤ 5.0 x ULN in the presence of liver metastases; bilirubin \\\u003C1.5 x ULN (unless known or suspected Gilbert syndrome, then \\\u003C3 x ULN is permitted)\n    * Adequate renal function: calculated creatinine clearance ≥ 50 ml\u002Fmin (using the MDRD or CKD EPI method).\n14. For sexually active men with female partners of reproductive potential or with pregnant women, agreement to use a condom with another effective contraceptive method during trial participation and up to 14 weeks after study treatment completion.\n15. Affiliated to the social security system or in possession of equivalent private health insurance (according to local regulations for participation in clinical trials).\n16. Willing and able to comply with the protocol for the duration of the trial including undergoing treatment and scheduled visits, and examinations including follow-up.\n\nExclusion Criteria:\n\nPatients presenting with any of the following criteria are not eligible:\n\n1. Any evidence of cancer progression (including a rising PSA level, clinical progression, or radiological progression)\n2. Prior or concurrent PSMA-based radioligand therapy or other PSMA target treatments\n3. Known hypersensitivity to the components of the study therapy or its analogs\n4. Any condition preventing the use of the standard of care and\u002For specific experimental treatments tested in the trial\n5. Any of the following within 6 months before randomization: stroke, myocardial infraction, severe\u002Funstable angina pectoris, coronary\u002Fperipheral artery bypass graft, congestive heart failure New York Heart Association (NYHA) Class III or IV\n6. Hypertension not controlled by an anti-hypertensive treatment (systolic blood pressure \\[sBP\\] ≥ 160 mmHg or diastolic blood pressure \\[dBP\\] ≥ 95 mmHg, 3 consecutive measures taken 5 minutes apart)\n7. Severe or uncontrolled concurrent disease, infection or co-morbidity\n8. Pathological findings consistent with small cell carcinoma of the prostate\n9. History of malignancy within 3 years of the current diagnosis with the exception of successfully treated basal cell or squamous cell skin carcinoma\n10. Ongoing participation in another clinical trial involving an investigational product.. Treatment with an investigational product must have ended within 28 days prior to the day of randomization\n11. Patients unwilling or unable to comply with the medical follow-up required by the trial because of geographic, familial, social, or psychological reasons\n12. Persons deprived of their liberty or under protective custody or guardianship",{"count":667,"type":21},500,[144],"PEACE-6 Poor Responders is an international, multicenter, open-label, controlled, randomized, phase III trial to evaluate the efficacy and safety of 177Lu-PSMA-617 when administered on top of the ongoing standard systemic treatment compared to standard systemic treatment alone in patients with de novo metastatic hormone-sensitive prostate cancer (mHSPC) who do not present with a satisfactory response characterized by a serum prostatic specific antigen (PSA) level of ≥ 0.2 ng\u002FmL at 6 to 8 months after systemic treatment initiation for mHSPC (i.e. poor responders) in the absence of evidence of cancer progression (including a rising PSA level).",[31],[672,673,674,675,676],"Genital Diseases, Male","Prostatic Diseases","Hormones","177Lu-PSMA-617","PSA","2024-12-17",{"date":679,"type":42},"2024-12-20",{"date":681,"type":42},"2024-09-12",{"date":683,"type":21},"2039-08-01",{"name":180,"class":49}]