[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"prostatic-neoplasms\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:prostatic-neoplasms":28},{"pageToken":4,"total":5,"offset":6,"count":7,"results":8},null,42,0,25,[9,42,72,101,142,152,173,197,233,255,277,307,330,349,368,387,409,442,486,508,535,555,580,607,631],{"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":4,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":30,"lastUpdatePostDateStruct":31,"startDateStruct":34,"completionDateStruct":36,"leadSponsor":38,"locationsCount":41},"100054324","phase-3-a-clinical-study-of-ifinatamab-deruxtecan-i-dxd-in-people-with-metastatic-prostate-cancer-mk-2400-001-100054324",false,"NCT06925737","A Clinical Study of Ifinatamab Deruxtecan (I-DXd) in People With Metastatic Prostate Cancer (MK-2400-001)","A Phase 3, Open-label Study of Ifinatamab Deruxtecan Versus Docetaxel in Participants With Metastatic Castration-Resistant Prostate Cancer (mCRPC) (IDeate-Prostate01)","Inclusion Criteria:\n\nThe main inclusion criteria include but are not limited to the following:\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 (ADT) (or post bilateral orchiectomy) within 6 months prior to 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 (CT)\u002Fmagnetic resonance imaging (MRI)\n* Has received prior treatment with 1 or 2 androgen receptor pathway inhibitors (ARPIs) and progressed during or after at least 8 weeks of treatment\n* Has provided tumor tissue from a core or excisional biopsy from soft tissue not previously irradiated and obtained after disease progression on the most recent prior therapy\n* Has recovered from adverse events (AEs) due to previous anticancer therapies\n\nExclusion Criteria:\n\nThe main exclusion criteria include but are not limited to the following:\n\n* Is unable to swallow tablets\u002Fcapsules\n* Has any of the following indicators of interstitial lung disease (ILD)\u002Fpneumonitis:\n\n  1. Has any history of ILD\u002Fpneumonitis that required steroid use, except for a history of radiation pneumonitis that did not require steroids\n  2. Has current ILD\u002Fpneumonitis\n  3. Has a clinical or radiographic suspicion of ILD for which the diagnosis of ILD cannot be ruled out\n* Has clinically severe pulmonary compromise resulting from intercurrent pulmonary illnesses\n* Has uncontrolled or significant cardiovascular disease\n* Has received prior treatment with a taxane-based chemotherapy agent for metastatic castration-resistant prostate cancer (mCRPC)\n* Has had prior discontinuation of an antibody drug conjugate (ADC) that consists of an exatecan derivative (eg, trastuzumab deruxtecan) due to treatment-related toxicities\n* Has a \"superscan\" bone scan","MALE","18 Years",{"count":20,"type":21},1440,"ESTIMATED","INTERVENTIONAL",[24],"PHASE3","Researchers are looking for new ways to treat metastatic castration-resistant prostate cancer (mCRPC). Researchers have designed a study medicine called ifinatamab deruxtecan (also called I-DXd or MK-2400) to treat mCRPC. The goal of this study is to learn if people who receive I-DXd live longer overall and live longer without the cancer growing or spreading than people who receive chemotherapy.",[27,28],"Prostate Cancer","Prostatic Neoplasms","RECRUITING","2026-07-10",{"date":32,"type":33},"2026-07-13","ACTUAL",{"date":35,"type":33},"2025-05-13",{"date":37,"type":21},"2031-01-06",{"name":39,"class":40},"Merck Sharp & Dohme LLC","INDUSTRY",290,{"id":43,"slug":44,"hasResults":12,"nctId":45,"briefTitle":46,"officialTitle":47,"acronym":4,"eligibilityCriteria":48,"healthyVolunteers":12,"sex":49,"minAge":18,"maxAge":4,"enrollmentInfo":50,"targetDuration":4,"studyType":22,"phases":52,"briefSummary":55,"conditions":56,"keywords":4,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":62,"lastUpdatePostDateStruct":63,"startDateStruct":65,"completionDateStruct":67,"leadSponsor":69,"locationsCount":71},"100573826","phase-1-a-study-of-dm002-in-patients-with-advanced-solid-tumors-100573826","NCT06751329","A Study of DM002 in Patients With Advanced Solid Tumors","A Phase I\u002FIIa, Multicenter, Open-label, First-in-Human, Dose Escalation and Expansion Study of DM002 in Patients With Advanced Solid Tumors","Inclusion Criteria:\n\nCommon Inclusion Criteria (Part 1 and Part 2)\n\n1. Subjects must have the ability to understand and willingness to sign a written informed consent document.\n2. Subjects must be ≥18 years of age at the time of signing the informed consent form.\n3. Subjects must have an Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1 or 2.\n4. Has a life expectancy of ≥3 months.\n5. Participants must meet the following laboratory values within 7 days prior to first dose of study drug:\n\n   Note: Transfusion (red blood cell or platelet) or granulocyte-colony stimulating factor (G-CSF) administration is not allowed within 2 weeks prior to laboratory assessments at Screening.\n   * Absolute neutrophil count (ANC) ≥1.5 × 10⁹\u002FL;\n   * Platelet count ≥100 × 10⁹\u002FL;\n   * Hemoglobin ≥9 g\u002FdL;\n   * Calculated creatinine clearance (CrCL) \\>60 mL\u002Fmin (Cockroft-Gault Equation);\n   * Total bilirubin ≤ 1.5 x ULN;\n   * Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤3.0 × upper limit of normal (ULN), if liver metastases are present, ≤5 × ULN;\n   * International normalized ratio (INR)\\\u003C2.0, and prothrombin time and either partial thromboplastin time (PTT) or activated PTT (aPTT) ≤1.5 × ULN, except for participants receiving anti-vitamin K derivative anticoagulant therapy who must have prothrombin time\u002FINR within therapeutic range as deemed appropriate by the Investigator.\n6. Has measurable disease based on RECIST version 1.1.\n7. Participants are required to provide tumor tissue specimens obtained within the previous 3 years for the measurement of MUC1 and\u002For HER3 and other biomarkers. For those subjects who are unable to provide tissue samples will be encouraged (but not mandatory) to undergo biopsy if the risk is manageable. If the biopsy is not possible, it should inform the sponsor for enrolment.\n\nExclusion Criteria:\n\n1. Subjects have another active invasive malignancy within 5 years, with the following exceptions and notes:\n\n   1. History of noninvasive malignancy, such as cervical cancer in situ, in situ melanoma, or ductal carcinoma in situ of the breast that is in complete remission 5 years after treatment with curative intent is allowed.\n   2. Malignancies with a negligible risk of metastasis or death (such as adequately treated basal or squamous cell skin cancer and localized prostate cancer).\n2. Current or history of a hematologic malignancy.\n3. Anticancer therapy (chemotherapy, immunotherapy, hormonal therapy, targeted therapy, biologic therapy, or other anti-cancer therapies, except for hormones for hypothyroidism or estrogen replacement therapy, anti-estrogen analogs, agonists required to suppress serum testosterone levels) within 28 days or 5 half-lives, whichever is shorter, prior to the first study dose. Radiotherapy with a wide field of radiation within 28 days, or radiotherapy with a limited field of radiation for palliation within 14 days of the first study dose. Major surgery, other than diagnostic surgery, within 4 weeks of the first study dose.\n4. Primary central nervous system (CNS) malignancies or CNS metastases. Individuals with brain metastases can be enrolled only if treated, nonprogressive brain metastases and off high-dose steroids (\\>20 mg prednisone or equivalent) for at least 4 weeks.\n5. History of known allergies to ADC, or prior discontinuation of an ADC due to treatment-related toxicities. Has received prior treatment with ADCs that include topoisomerase I (Topo I) payload, and treatment history with any investigational drug within 4 weeks before enrolment in the study.\n6. Has an uncontrolled infection requiring IV injection of antibiotics, antivirals, or antifungals.\n7. Has a pre-existing clinically significant lung diseases (e.g., interstitial pneumonia, pneumonitis, pulmonary fibrosis, and severe radiation pneumonitis) or pre-existing ocular disorders.\n8. Clinically uncontrolled intercurrent illness, including but not limited to an ongoing active infection, active coagulopathy, uncontrolled cardiovascular disease, uncontrolled immune disease, uncontrolled diabetes, uncontrolled pleural and peritoneal effusion, psychiatric illness that would limit compliance with the study requirements and other serious medical illnesses requiring systemic therapies.\n9. Mean resting corrected QT interval corrected by Fridericia's formula (QTcF) \\>470 msec obtained from triplicate 12-lead ECGs at baseline; using concomitant medications that would prolong the QT interval.\n10. Left ventricular ejection fraction \\\u003C50% by either an echocardiogram (ECHO) or a multi-gated acquisition scan within 28 days before first dose of the study drug.\n11. Known active hepatitis B (HBV) or hepatitis C (HCV) infection. Chronic carriers of HBV infection (HBsAg-positive, undetectable HBV DNA or HBV DNA ≤2500 copies\u002Fml or 500 IU\u002Fml) receive prophylactic treatment during the study can be enrolled. Participants with a history of HCV infection have completed curative antiviral treatment and HCV viral load below the limit of quantification and HCV antibody positive but HCV ribonucleic acid (RNA) negative due to prior treatment or natural resolution should be eligible.\n12. Known human immunodeficiency virus (HIV) infection which is not well controlled. Participants should be tested for HIV prior to enrollment if required by local regulations or institutional review board (IRB)\u002Fethics committee. All the following criteria are required to define an HIV infection (positive HIV1\u002F2 antibodies test) that is well controlled: HIV viral load \\\u003C400 copies\u002FmL, CD4+ T- cell counts ≥350 cells\u002FμL, no history of acquired immunodeficiency syndrome-defining opportunistic infection within the past 12 months, and stable viral load for at least 4 weeks on same anti-HIV retroviral medications.\n13. Subjects who are from endemic areas (refer to WHO high tuberculosis burden country list, China is endemic area) will be specifically screened for tuberculosis with any available test. Subjects with active tuberculosis are excluded. Subjects who have received bacille Calmette-Guerin vaccination may have a false positive result of purified-protein derivative (PPD) test. These subjects are eligible if they have a negative result of interferon gamma release assay (IGRA).\n14. Has received a live vaccine within 30 days prior to the first dose of study drug.\n15. Has unresolved toxicities from previous anticancer therapy, defined as toxicities (other than alopecia and anemia) not yet resolved to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE) version 5.0, ≤Grade 1 or baseline. Note: Participants may be enrolled with chronic, stable Grade 2 toxicities (defined as no worsening to \\>Grade 2 for at least 3 months prior to enrolment\u002Frandomization and managed with the standard treatment) that the Investigator deems related to previous anticancer therapy, following discussion with the Sponsor's medical monitor, such as the following: Grade 2 chemotherapy-induced neuropathy, hypothyroidism, hyperglycemia.\n16. Females who are pregnant or lactating or who intend to become pregnant during participation in the study are not eligible to participate.\n17. Participants who are of reproductive potential refuse to use effective methods of birth control during participation of the study and within 7 months for female (and 4 months for male) after the last dose administration.\n18. Participants who took drugs or food which can strongly inhibit or induce the cytochrome P450 (CYP) isoenzyme, CYP3A4\u002F5 within 2 weeks prior to the first dose of DM002 or within 5 half-lives, whichever is longer.","ALL",{"count":51,"type":21},280,[53,54],"PHASE1","PHASE2","The goal of study：\n\nThe study has two parts: Part 1 Dose Escalation and Part 2 Dose Expansion.\n\nIn Part 1, a few participants will receive the lowest dose of study drug. The study team will make sure it is safe and tolerated before enrolling new participants at a higher dose of study drug. There will be up to six or more dose levels of study drug tested (called cohorts). Which dose you receive will depend on how many participants have taken part in the study before you.\n\nThe purpose of Part 1 of the study is to evaluate the safety of the study drug at different dose levels, to understand what your body does to the study drug, and to find the best dose of study drug in people who have advanced solid tumor cancers.\n\nIn Part 2, participants will receive the best dose level that was determined in Part 1 of the study.\n\nThe purpose of Part 2 of the study is to evaluate the safety of the study drug at the dose level determined in Part 1, to understand what your body does to the study drug, and to see how your cancer responds to the study drug.\n\nParticipants will:\n\nParticipants will have 17 or more visits to the study centre. This study has a screening phase of up to 28 days , and a treatment phase with cycles of 21 days each. Participants will also have an End of Treatment (EOT) visit 21 days after the final study drug treatment, and a Follow-up visit 30 days after the EOT visit . Participants will be contacted by telephone every 3 months after the Follow-up visit to check on the wellbeing and record any new anticancer therapy they may have started.",[57,28,58,59,60,61],"Ovarian Neoplasms","Endometrial Neoplasms","Colorectal Neoplasms","Solid Carcinoma","Pancreatic Cancer","2026-07-01",{"date":64,"type":33},"2026-07-02",{"date":66,"type":33},"2025-02-17",{"date":68,"type":21},"2028-04-18",{"name":70,"class":40},"Xadcera Biopharmaceutical (Suzhou) Co., Ltd.",5,{"id":73,"slug":74,"hasResults":12,"nctId":75,"briefTitle":76,"officialTitle":77,"acronym":4,"eligibilityCriteria":78,"healthyVolunteers":12,"sex":17,"minAge":79,"maxAge":80,"enrollmentInfo":81,"targetDuration":4,"studyType":83,"phases":4,"briefSummary":84,"conditions":85,"keywords":86,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":62,"lastUpdatePostDateStruct":92,"startDateStruct":93,"completionDateStruct":95,"leadSponsor":97,"locationsCount":100},"100347604","men-at-high-genetic-risk-for-prostate-cancer-100347604","NCT03805919","Men at High Genetic Risk for Prostate Cancer","Natural History Study of Men at High Genetic Risk for Prostate Cancer","* Inclusion Criteria:\n* Males between ages 30-75 years old.\n* Documented germline variant (i.e. pathogenic\u002Flikely pathogenic variant) in prostate cancer risk-related gene from a CLIA certified laboratory: BRCA1 and BRCA2, MMR genes (MLH1, MSH2, MSH6, PMS2, and EPCAM) associated with Lynch syndrome, as well as HOXB13, ATM, NBN, TP53, CHEK2, PALB2, RAD51C, RAD51D, BRIP1, or FANC (FANCA, FANCB, FANCC, FANCD2, FANCE, FANCF, FANCG, FANCI, FANCL, and FANCM).\n* Prognosis of \\>5 years survival if affected by another cancer\n* Ability of subject to understand and the willingness to sign a written informed consent document\n\nExclusion Criteria:\n\n* Prior diagnosis or treatment for prostate cancer\n* Known contraindication to MRI:\n\n  * Participants unable to fit through MRI scanner (radiologist discretion)\n  * Allergy to MR contrast agent\n  * Participants with pacemakers, cerebral aneurysm clips, shrapnel injury, or implantable electronic device\n* Active concomitant medical or psychological illnesses that may increase the risk to the subject or inability to obtain informed consent, at the discretion of the principal investigator.","30 Years","75 Years",{"count":82,"type":21},500,"OBSERVATIONAL","Background:\n\nResearch studies have shown that genetic changes and family history may increase a man s risk for prostate cancer. Researchers want to follow the prostate health of men who have specific genetic changes associated with prostate cancer to help them learn more about which men are at higher risk for prostate cancer.\n\nObjectives:\n\nTo study men with specific genetic changes and determine who is at higher risk for getting prostate cancer. To study if certain genetic changes and family history can be used to help prevent or treat prostate cancer.\n\nEligibility:\n\nMales between ages 30-75 who have one or more specific genetic changes but without prostate cancer.\n\nDesign:\n\n* This study does not perform genetic testing. All participants must have documented genetic changes and able to provide a copy of the report.\n* Before enrollment, participants will provide a copy of documented genetic changes and go through a telephone interview to determine eligibility for the study.\n* On enrollment, participants will have medical and family history review, medication review, physical exam, blood collection for clinical and research testing, and MRI (magnetic resonance imaging) of the prostate.\n* Every year, participants will repeat the physical exam, medical history, family history, medication review, routine blood tests, including PSA and testosterone.\n* Every 2 years, participants will repeat all the above plus prostate MRI and blood tests for research.\n* If, at any time, the physical exam, blood tests or MRI are abnormal, participants may be asked to do a biopsy.\n* If the biopsy results in prostate cancer, participants will be given counseling on next steps, general treatment recommendations, and then followed with a phone call each year.\n* Participants may ask to speak with a genetic counselor....",[28],[87,88,89,90,91],"BRCA 1","BRCA 2","MMR genes","Lynch Syndrome","Natural History",{"date":64,"type":33},{"date":94,"type":33},"2019-03-27",{"date":96,"type":21},"2039-01-01",{"name":98,"class":99},"National Cancer Institute (NCI)","NIH",1,{"id":102,"slug":103,"hasResults":12,"nctId":104,"briefTitle":105,"officialTitle":106,"acronym":107,"eligibilityCriteria":108,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":109,"targetDuration":4,"studyType":22,"phases":111,"briefSummary":113,"conditions":114,"keywords":119,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":132,"lastUpdatePostDateStruct":133,"startDateStruct":134,"completionDateStruct":136,"leadSponsor":138,"locationsCount":141},"100630129","non-inferiority-study-comparing-salvage-pelvic-radiotherapy-in-25-fractions-625-gy25-versus-20-fractions-525-gy20-for-recurrent-prostate-cancer-after-surgery-100630129","NCT07483658","Non-inferiority Study Comparing Salvage Pelvic Radiotherapy in 25 Fractions (62.5 Gy\u002F25) Versus 20 Fractions (52.5 Gy\u002F20) for Recurrent Prostate Cancer After Surgery.","Non-Inferiority Study Comparing Hypofractionated Post-Operative Salvage Radiotherapy Regimens: 45\u002F62.5 Gy in 25 Fractions vs. 43\u002F52.5 Gy in 20 Fractions for Grade 2+ GU or GI Toxicity (HYP-OP-RT)","HYP-OP-RT","Inclusion Criteria:\n\n* Histologically confirmed prostate adenocarcinoma.\n* Prior radical prostatectomy with detectable PSA (≥0.2 ng\u002FmL).\n* No evidence of distant metastasis (confirmed via bone scan and CT\u002FMRI or TEP-PSMA if PSA is above 0.5 ng \u002Fml).\n* Patient with Nodal recurrence within the pelvis are eligible\n* ECOG performance status 0-2.\n* Age ≥ 18 years.\n* Adequate baseline renal, hepatic, and hematologic function.\n\nExclusion Criteria:\n\n* Prior pelvic radiotherapy.\n* Macroscopic local relapse on imaging\n* Presence of metastatic disease.\n* Active inflammatory bowel disease or other GI conditions predisposing to radiation toxicity.\n* Uncontrolled comorbidities affecting study participation.\n* Prior systemic therapy for recurrent prostate cancer (except ADT within 6 months).",{"count":110,"type":21},434,[112],"NA","Study Overview This research compares two types of post-operative salvage radiotherapy (SRT) for men with prostate cancer who have had surgery but show signs of recurrence (detectable PSA). The goal is to see if a shorter treatment schedule is as safe and effective as the standard schedule.\n\nWhy is this study important? After prostate surgery, cancer can return in up to 70-80% of high-risk patients. Radiotherapy helps control this, but the best way to deliver it-especially the number of sessions and whether to treat the pelvic area-is still being studied. Shorter treatments could mean less time in therapy and better quality of life, if such treatments are proven safe.\n\nWhat is being compared?\n\nStandard treatment (Arm A):\n\n25 sessions (about 5 weeks) Prostate bed: 62.5 Gy Pelvis: 45 Gy\n\nShorter treatment (Arm B):\n\n20 sessions (about 4 weeks) Prostate bed: 52.5 Gy Pelvis: 43 Gy\n\nBoth groups may also receive hormone therapy (ADT) for 6-24 months.\n\nMain Goal To check if the shorter treatment causes no more side effects (urinary or bowel problems) than the standard treatment, while keeping cancer control similar.\n\nOther Things to be Measured\n\nCancer control (PSA levels, spread of disease) Survival Quality of life (urinary, bowel, sexual health questionnaires)\n\nWho can join?\n\nMen who:\n\nHad prostate surgery Have a detectable PSA (≥0.2 ng\u002FmL) No distant metastasis Are in good general health (ECOG 0-2)\n\nHow long will the study last?\n\nAbout 12 years total:\n\n2 years to enroll patients 10 years of follow-up",[115,116,27,28,117,118],"Reccurent\u002FMetastatic Solid Tumor Disease","Prostate Cancer (Post Prostatectomy)","Neoplasm Recurrence, Local","Biochemical Recurrence of Malignant Neoplasm of Prostate",[120,121,122,123,124,125,126,127,128,129,130,131],"Radiotherapy, Adjuvant","Radiotherapy, Intensity-Modulated","Radiotherapy, High-Dose Hypofractionated","Pelvic Radiotherapy","Androgen Deprivation Therapy","Randomized Controlled Trials","Noninferiority Trials","Quality of Life","Treatment Outcome","Gastrointestinal Diseases \u002F chemically induced","Urinary Tract Diseases \u002F chemically induced","Radiation Injuries","2026-06-29",{"date":62,"type":33},{"date":135,"type":33},"2026-05-13",{"date":137,"type":21},"2036-02",{"name":139,"class":140},"CHU de Quebec-Universite Laval","OTHER",4,{"id":143,"slug":4,"hasResults":12,"nctId":13,"briefTitle":14,"officialTitle":15,"acronym":4,"eligibilityCriteria":16,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":144,"targetDuration":4,"studyType":22,"phases":145,"briefSummary":25,"conditions":146,"keywords":4,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":147,"lastUpdatePostDateStruct":148,"startDateStruct":149,"completionDateStruct":150,"leadSponsor":151,"locationsCount":41},"100587234",{"count":20,"type":21},[24],[27,28],"2026-06-26",{"date":132,"type":33},{"date":35,"type":33},{"date":37,"type":21},{"name":39,"class":40},{"id":153,"slug":154,"hasResults":12,"nctId":155,"briefTitle":156,"officialTitle":157,"acronym":4,"eligibilityCriteria":158,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":159,"enrollmentInfo":160,"targetDuration":4,"studyType":83,"phases":4,"briefSummary":162,"conditions":163,"keywords":164,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":167,"lastUpdatePostDateStruct":168,"startDateStruct":170,"completionDateStruct":4,"leadSponsor":172,"locationsCount":100},"100196500","imaging-studies-to-check-the-local-response-of-prostate-cancer-to-radiation-therapy-100196500","NCT01834001","Imaging Studies to Check the Local Response of Prostate Cancer to Radiation Therapy","Evaluation of Local Response of Prostate Cancer to Irradiation Using Multiparametric MRI and MR-Guided Biopsies","* INCLUSION CRITERIA: men with untreated prostate cancer.\n\n  1. Patients must have histologically or cytologically confirmed prostate cancer. The outside pathology report is acceptable for study entry. Every effort will be made to acquire the outside pathology slides to be confirmed by the Laboratory of Pathology, NCI.\n  2. Intermediate or high risk prostate cancer (clinical tumor stage T2b or higher, Gleason 7 or higher, or PSA greater than 10). Previously obtained MR imaging may be used for clinical T staging (extracapsular extension, seminal vesicle invasion).\n  3. No prior local therapy (prostatectomy, radiation, cryotherapy) or hormonal therapy for prostate cancer.\n  4. Age \\>18 years.\n  5. ECOG performance status \\\u003C2 (Karnofsky \\>60%).\n  6. Radiotherapy is planned as definitive therapy for prostate cancer. For patients not treated at NCI ROB patients must have a radiation oncologist who is willing to collaborate with the ROB and provide documentation of treatment.\n  7. Ability of subject to understand and the willingness to sign a written informed consent document.\n\nINCLUSION CRITERIA: for men with presumed prostate cancer relapse\n\n1. Patients must have a history of histologically or cytologically confirmed prostate cancer. The outside pathology report is acceptable for study entry. Every effort will be made to acquire the outside pathology slides to be confirmed by the Laboratory of Pathology, NCI\n2. Age greater than or equal to 18 years.\n3. ECOG performance status less than or equal to 2 (Karnofsky greater than or equal to 60%).\n4. Radiotherapy (external beam irradiation alone or in combination with hormonal therapy and\u002For brachytherapy) was delivered as definitive therapy for prostate cancer and documentation is available.\n5. Evidence of prostate cancer recurrence (biochemical relapse by the Phoenix definition, enlarging palpable prostatic abnormality, imaging evidence strongly suggestive of local failure)\n6. Ability of subject to understand and the willingness to sign a written informed consent document.\n\nEXCLUSION CRITERIA:\n\n1. Patients unable to tolerate MRI (patients with pacemakers, cerebral aneurysm clips, shrapnel injuries, or other implantable electronic devices or metal not compatible with MRI).\n2. Evidence of metastases (pelvic lymph node involvement is not an exclusion criteria). For patients with recurrent prostate cancer, oligometastatic disease (3 or fewer visible metastases) is not an exclusion criterion.\n3. Patients with coagulopathies who are at increased risk for bleeding or on active anticoagulation therapy (platelets less than 100,000 per mm\\^3 or PT\u002FPTT greater than 1.5 times the upper normal limit (UNL). Patients are eligible if the underlying cause is correctable.\n4. Subject s weight exceeding MRI or radiation treatment table tolerance.\n5. Patients with active urinary tract infections.\n6. Patients with renal insufficiency with a GFR less than 30, due to the fact that they will not be able to undergo gadolinium enhanced MRI.\n7. Uncontrolled illness or comorbidity that in the judgment of the PI would preclude participation in the study.\n8. Hepatitis B or Hepatitis C active infection.\n9. HIV-positive patients are ineligible because HIV is known to increase radiation toxicity and may result in under-dosing or alterations in the treatment plan that would alter the likelihood of local recurrence. Appropriate studies will be undertaken in HIV positive patients when indicated.","120 Years",{"count":161,"type":21},300,"Background:\n\n\\- Radiation is a common treatment for prostate cancer. It helps damage tumor cells and causes them to die. Radiation can be effective, but some tumors may be harder to treat with radiation or even with surgery. This happens to a small number of men who have either radiation or surgery for prostate cancer. Most men who have these hard-to-treat tumors do not know if the tumor has recurred only in the prostate or has spread to another area. Also, men whose prostate cancer has recurred only after radiation may have different treatment options. This study will use improved imaging studies to better understand why some men do not respond as well to initial radiation treatments.\n\nObjectives:\n\n\\- To use detailed imaging studies to look at the results of local radiation therapy for prostate cancer.\n\nEligibility:\n\n* Men at least 18 years of age who are scheduled to have radiation for prostate cancer.\n* Men at least 18 years of age whose prostate cancer has returned after earlier treatments.\n\nDesign:\n\n* All participants will have a medical history and physical exam. Blood and urine samples will be collected. Imaging studies will be used to evaluate the cancer at the start of the study.\n* All participants will have an initial full magnetic resonance imaging (MRI) scan of the prostate. Tumor and healthy tissue samples will be collected.\n* Those whose cancer has recurred after treatment will discuss possible treatment options with the study doctors.\n* Participants who are scheduled to have radiation will have radiation therapy. This will be given according to the current standard of treatment.\n* After radiation, participants will have regular follow-up tests and imaging studies. They will have another full MRI scan 6 months after the end of radiation treatment.",[28,27],[28,165,166,91],"Radiation","Biochemical Failure","2026-06-24",{"date":169,"type":33},"2026-06-25",{"date":171,"type":33},"2013-11-13",{"name":98,"class":99},{"id":174,"slug":175,"hasResults":12,"nctId":176,"briefTitle":177,"officialTitle":178,"acronym":4,"eligibilityCriteria":179,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":159,"enrollmentInfo":180,"targetDuration":4,"studyType":22,"phases":181,"briefSummary":182,"conditions":183,"keywords":185,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":189,"lastUpdatePostDateStruct":190,"startDateStruct":192,"completionDateStruct":194,"leadSponsor":196,"locationsCount":100},"100486636","phase-2-focal-therapy-with-stereotactic-body-radiation-therapy-sbrt-for-patients-with-a-single-prostate-tumor-100486636","NCT05616650","Focal Therapy With Stereotactic Body Radiation Therapy (SBRT) for Patients With a Single Prostate Tumor","A Phase II Trial of Focal Ultrahypofractionated Stereotactic Radiation Therapy for the Treatment of Unifocal Prostate Cancer","* INCLUSION CRITERIA:\n* Participants must have histologically confirmed, low or intermediate risk prostatic adenocarcinoma verified by biopsy (NIH Laboratory of Pathology confirmation is required).\n* Unifocal prostate cancer defined as a single focus of prostate cancer on MRI and PSMA PET\u002FCT imaging which is correlated with a positive targeted biopsy.\n* Age \\>=18 years.\n* ECOG performance status \\\u003C=2 (Karnofsky \\>60%).\n* Men must agree to use highly effective contraception with their partner (barrier method of birth control; abstinence) for the duration of study participation and up to 120 days after the last radiation treatment.\n* Ability of individual to understand and the willingness to sign a written informed consent document.\n\nEXCLUSION CRITERIA:\n\n* Participants with NCCN high-risk prostate cancer features (Gleason score \\>=8, \\>cT2c, or PSA \\>= 20 ng\u002FmL).\n* Participants with prostate biopsies which show \\>= grade group 2 adenocarcinoma determined to be outside of the radiographically visible lesion (systematic biopsies which map to a radiographically detected lesion are not an exclusion criterion).\n* Participants in whom concurrent systemic Androgen Deprivation Therapy (ADT) or chemotherapy is planned.\n* Participants who are receiving any other investigational agents.\n* Participants found to have pelvic or distant metastases on pre-treatment staging studies.\n* Participants with an AUA-SI\u002FIPSS score \\> 18.\n* Participants who have previously received curative treatment for a prior or the current diagnosis of prostate cancer.\n* Active urinary tract infection assessed by urinalysis.\n* Human immunodeficiency virus (HIV)-infected individuals who are not on effective anti-retroviral therapy. Participants on anti-retroviral therapy with undetectable viral load within the 6 months prior to registration are eligible for this trial.\n* Participants with hepatitis B virus (HBV) infection who have not been treated and cured.\n* Participants with chronic HBV at screening must have an undetectable HBV viral load on suppressive therapy.\n* Participants with hepatitis C virus (HCV) infection who have not been treated and cured.\n* Participants with HCV infection who are currently on treatment, are eligible if they have an undetectable HCV viral load at screening.\n* Anatomic relationship between the tumor and adjacent normal tissues judged to be unfeasible for the planned treatment by the PI.\n* Participants with connective tissue diseases.\n* Participants with radiation hypersensitivity syndromes.\n* Ongoing active inflammatory bowel disease within the radiation field.\n* Participants with prior medical comorbidity or surgical history involving the low pelvis which is expected to confer a high risk of toxicity to the experimental radiation regimen.\n* Ineligibility or unwillingness to undergo a contrast-enhanced MRI due to inadequate renal function (eGFR \\\u003C 30), severe claustrophobia, a weight above tolerance of the scanner (\\> 350 lbs.), a body size unable to fit into the scanner, or implanted devices incompatible with an MRI (implanted cardiac devices, surgical hardware, retained shrapnel, cerebral aneurysm clips, or other incompatible objects.\n* Unwillingness to undergo an 18F-DCFPyL PET\u002FCT or known allergy to the 18F-DCFPyL tracer.\n* Contraindication or inability to undergo fiducial marker implantation.\n* History of prior radiotherapy overlapping with the intended radiation field.\n* Uncontrolled intercurrent illness, factors, or social situations that would limit compliance with study requirements.",{"count":5,"type":21},[54],"Background:\n\nThe current standard treatment of prostate cancer is either surgery or radiation. Typically, this includes either the removal or radiation of the whole prostate gland. Many people now seek out focal therapy options to decrease the side effects of treatment. Until now, several forms of physical destruction with heat (thermal ablation), cold (cryotherapy), sound waves (HIFU), laser (FLA), and electrical energy (IRE). A new type of radiation (SBRT) may be an effective way to cure men of early-stage prostate cancer with fewer side effects than standard treatments.\n\nObjective:\n\nTo see how people with untreated localized prostate cancer will respond to focal therapy with SBRT.\n\nEligibility:\n\nPeople aged 18 years and older with untreated localized prostate cancer (prostate cancer which has not spread outside of the prostate gland).\n\nDesign:\n\n* Participants will undergo screening including blood tests, an MRI, a PSMA PET\u002FCT (18F-DCFPyL), and a biopsy.\n* Small, non-radioactive, gold seeds about the size of a grain of rice will be placed in and\u002For around the tumor to help target the radiation treatment.\n* Radiation (SBRT) will occur in 2 separate sessions about 1 week apart. No sedation is used, these sessions are painless. Each session will take about 1-2 hours. Participants can go home afterwards.\n* Follow-up will continue for 2 years with repeat scans (MRI and PSMA PET\u002FCT) and blood (PSA) tests.\n* After two years, a biopsy will be done to understand the impact of this new treatment on prostate cancer.",[28,27,184],"Prostate Adenocarcinoma",[186,187,188,184],"Sbrt","PSMA","Targeted Pet Imaging","2026-06-16",{"date":191,"type":33},"2026-06-17",{"date":193,"type":33},"2023-10-19",{"date":195,"type":21},"2031-12-01",{"name":98,"class":99},{"id":198,"slug":199,"hasResults":12,"nctId":200,"briefTitle":201,"officialTitle":202,"acronym":4,"eligibilityCriteria":203,"healthyVolunteers":12,"sex":49,"minAge":204,"maxAge":205,"enrollmentInfo":206,"targetDuration":4,"studyType":22,"phases":208,"briefSummary":209,"conditions":210,"keywords":215,"overallStatus":224,"whyStopped":4,"lastUpdateSubmitDate":225,"lastUpdatePostDateStruct":226,"startDateStruct":227,"completionDateStruct":229,"leadSponsor":231,"locationsCount":4},"100641936","nudging-preventive-screening-via-message-framing-and-bundling-100641936","NCT07644910","Nudging Preventive Screening Via Message Framing and Bundling","The Effect of Message Framing and Screening Bundling on Preventive Screening Engagement: A Randomized Field Experiment","Inclusion Criteria:\n\n* Has at least one pending cancer screening (breast, colorectal, cervical, or prostate) within the contact window, as determined by the medical institution\n* Aged 21 to 74 years\n* Has a valid phone number on file\n* Eligibility is determined operationally before randomization (ex-ante)\n\nExclusion Criteria:\n\n* Participants whose WhatsApp message was not successfully delivered, as reported by the third-party software used by the medical institution.","21 Years","74 Years",{"count":207,"type":21},235000,[112],"This study is a randomized controlled field experiment embedded in the medical institution Early Diagnosis Program in Chile. Participants with two exams pending (a cancer screening test and a chronic disease test for diabetes and dyslipidemia) will be randomly assigned across a 3 × 3 factorial design: three message framing conditions (Basic, Risk\u002FImportance, Peace of Mind) crossed with three exam-type conditions (cancer screening only, chronic disease test only, or both exams). Participants with only a cancer screening pending will be assigned to the 3 framing conditions and be encouraged to get the cancer screening.\n\nIn both cases, participants are assigned to each experimental arm at twice the rate of an additional arm receiving the standard message currently used by the medical institution. This standard-message arm is included for operational purposes, is not part of the pre-specified analyses, and is thus not described in the \"Arms and Intervention\" section (or counted for \"number of arms\").",[211,212,59,28,213,214],"Breast Neoplasms","Uterine Cervical Neoplasms","Diabetes Mellitus","Dyslipidemias",[216,217,218,219,220,221,222,223],"Behavioral science","randomized controlled trial","WhatsApp patient outreach","message framing","information avoidance","cancer screening","chronic disease testing","preventive care","NOT_YET_RECRUITING","2026-06-15",{"date":191,"type":33},{"date":228,"type":21},"2026-06-08",{"date":230,"type":21},"2026-12-08",{"name":232,"class":140},"University of Chile",{"id":234,"slug":235,"hasResults":12,"nctId":236,"briefTitle":237,"officialTitle":238,"acronym":4,"eligibilityCriteria":239,"healthyVolunteers":12,"sex":49,"minAge":18,"maxAge":4,"enrollmentInfo":240,"targetDuration":4,"studyType":22,"phases":242,"briefSummary":243,"conditions":244,"keywords":4,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":246,"lastUpdatePostDateStruct":247,"startDateStruct":249,"completionDateStruct":251,"leadSponsor":253,"locationsCount":254},"100526585","phase-3-a-study-of-opevesostat-mk-5684-versus-alternative-next-generation-hormonal-agent-nha-in-metastatic-castration-resistant-prostate-cancer-mcrpc-post-one-nha-mk-5684-004-100526585","NCT06136650","A Study of Opevesostat (MK-5684) Versus Alternative Next-generation Hormonal Agent (NHA) in Metastatic Castration-resistant Prostate Cancer (mCRPC) Post One NHA (MK-5684-004)","MK-5684-004: A Phase 3, Randomized, Open-label Study of Opevesostat Versus Alternative Abiraterone Acetate or Enzalutamide in Participants With Metastatic Castration-resistant Prostate Cancer (mCRPC) That Progressed On or After Prior Treatment With One Next-generation Hormonal Agent (NHA) (OMAHA-004)","Inclusion Criteria:\n\nThe main inclusion criteria include but are not limited to the following:\n\n* Have histologically or cytologically confirmed adenocarcinoma of the prostate without small cell histology\n* Has prostate cancer progression while receiving androgen deprivation therapy (ADT) (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 shown by computed tomography (CT)\u002Fmagnetic resonance imaging (MRI)\n* Has disease that progressed during or after treatment with one next-generation hormonal agent (NHA) for hormone sensitive prostate cancer (HSPC) (metastatic hormone-sensitive prostate cancer \\[mHSPC\\] or non-metastatic hormone-sensitive prostate cancer \\[nmHSPC\\]), or castration-resistant prostate cancer (CRPC) (metastatic castration-resistant prostate cancer \\[mCRPC\\] or non-metastatic castration-resistant prostate cancer \\[nmCRPC\\]), for at least 8 weeks of NHA treatment (at least 14 weeks of NHA treatment for participants with bone progression). Note: Participants may have received abiraterone acetate and docetaxel or darolutamide and docetaxel for HSPC. However, participants must have received no more than 6 cycles of docetaxel and had no radiographic disease progression while receiving docetaxel\n* Has had prior treatment with poly (ADP-ribose) polymerase inhibitor (PARPi) or were deemed ineligible to receive treatment by the investigator or have refused PARPi treatment\n* Has ongoing androgen deprivation therapy (ADT) with serum testosterone \\\u003C50 ng\u002FdL (\\\u003C1.7 nM)\n* Has an eastern clinical oncology group (ECOG) performance status of 0 or 1 assessed within 10 days before randomization\n* Has adequate organ function\n* Has provided tumor tissue from a fresh core or excisional biopsy from soft tissue not previously irradiated. Samples from tumors progressing at a prior site of radiation are allowed\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 have adverse event (AEs) due to previous anticancer therapies must have recovered to ≤Grade 1 or baseline. Participants with endocrine-related AEs who are adequately treated with hormone replacement therapy (HRT) or participants who have ≤Grade 2 neuropathy or ≤Grade 2 osteopenia\u002Fosteoporosis are eligible\n* Human immunodeficiency virus (HIV)-infected participants must have well controlled HIV on antiretroviral therapy (ART)\n\nExclusion Criteria:\n\nThe main exclusion criteria include but are not limited to the following:\n\n* Has presence of gastrointestinal condition\n* Is unable to swallow capsules\u002Ftablets\n* Has history of pituitary dysfunction\n* Has poorly controlled diabetes mellitus\n* Has clinically significant abnormal serum potassium or sodium level\n* Has any of the following at screening visit: Hypotension: systolic blood pressure (BP) \\\u003C110 mmHg, or uncontrolled hypertension: systolic BP ≥160mmHg or diastolic blood BP ≥90 mmHg, in 2 out of the 3 recordings with optimized antihypertensive therapy\n* Has a history of active or unstable cardio\u002Fcerebrovascular disease, including thromboembolic events\n* History or family history of long QTc syndrome\n* Has a history of seizure(s) within 6 months before providing documented informed consent (IC) or has any condition that may predispose to seizure within 12 months prior to the date of enrollment\n* Has a history of clinically significant ventricular arrhythmias or Mobitz II second degree or third-degree heart block without a permanent pacemaker in place\n* Has received a taxane-based chemotherapy for metastatic castration-resistant prostate cancer (mCRPC)\n* Has not adequately recovered from major surgery or have ongoing surgical complications\n* Is currently being treated with Cytochrome P450 (CYP450)-inducing antiepileptic drugs for seizures\n* Participants on an unstable dose of thyroid hormone therapy, as judged by the investigator, within 6 months before the start of the study intervention\n* Receives prior radiotherapy within 2 weeks before the first dose of study intervention, or radiation-related toxicities, requiring corticosteroids\n* Receives prior systemic anticancer therapy including investigational agents within 4 weeks before the first dose of study intervention\n* Has systemic use of strong Cytochrome P450 3A4 (CYP3A4) inducers and P-glycoprotein (P-gp) inhibitors within 2 weeks before the first dose of study intervention\n* Has received prior targeted small molecule therapy or NHA treatment within 4 weeks before the first dose of study intervention\n* Received a live or live-attenuated vaccine within 30 days before the first dose of study intervention\n* Has received an investigational agent or has used an investigational device within 4 weeks prior to study intervention administration\n* Has known hypersensitivity to the components or excipients in abiraterone acetate, prednisone or prednisolone, enzalutamide, fludrocortisone, dexamethasone, or opevesostat\n* Has a \"superscan\" bone scan defined as an intense symmetric activity in the bones and diminished renal parenchymal activity on baseline bone scan such that the presence of additional metastases in the future could not be evaluated\n* Has known additional malignancy that is progressing or has required active treatment within the past 3 years\n* Diagnosis of immunodeficiency or is receiving chronic systemic steroid therapy (in dosing exceeding 10 mg daily of prednisone equivalent) or any other form of immunosuppressive therapy within 7 days prior the first dose of study medication\n* Has known active central nervous system (CNS) metastases and\u002For carcinomatous meningitis. Participants with previously treated brain metastases may participate provided they are radiologically stable, (ie, without evidence of progression) for at least 4 weeks as confirmed by repeat imaging performed during study screening, are clinically stable and have not required steroid treatment for at least 14 days prior to the first dose of study intervention\n* Has active autoimmune disease that has required systemic treatment in the past 2 years. Replacement therapy is allowed\n* Active infection requiring systemic therapy\n* Has concurrent active Hepatitis B virus and Hepatitis C virus infection",{"count":241,"type":21},1314,[24],"The purpose of this study is to assess the efficacy and safety of opevesostat plus hormone replacement therapy (HRT) compared to alternative abiraterone acetate or enzalutamide in participants with Metastatic Castration-resistant Prostate Cancer (mCRPC) previously treated with one next-generation hormonal agent (NHA). The primary study hypothesis is that opevesostat is superior to alternative abiraterone acetate or enzalutamide with respect to radiographic progression free survival (rPFS) per Prostate Cancer Working Group (PCWG) Modified Response Evaluation Criteria in Solid Tumors (RECIST 1.1), as assessed by Blinded Independent Central Review (BICR), in androgen receptor ligand binding domain (AR LBD) mutation positive and negative participants.",[245,28],"Metastatic Castration-resistant Prostate Cancer (mCRPC)","2026-06-05",{"date":248,"type":33},"2026-06-09",{"date":250,"type":33},"2023-12-18",{"date":252,"type":21},"2030-12-02",{"name":39,"class":40},329,{"id":256,"slug":257,"hasResults":12,"nctId":258,"briefTitle":259,"officialTitle":259,"acronym":4,"eligibilityCriteria":260,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":261,"targetDuration":4,"studyType":83,"phases":4,"briefSummary":263,"conditions":264,"keywords":268,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":246,"lastUpdatePostDateStruct":273,"startDateStruct":274,"completionDateStruct":4,"leadSponsor":276,"locationsCount":100},"100127142","collection-of-blood-from-patients-with-prostate-cancer-100127142","NCT00923221","Collection of Blood From Patients With Prostate Cancer","* INCLUSION CRITERIA:\n\nIndividuals 18 years of age and older are eligible.\n\nIndividuals with a diagnosis of prostate cancer are eligible.\n\nEXCLUSION CRITERIA:\n\nChildren are not eligible.",{"count":262,"type":21},1000,"Background:\n\n* It is not fully understood why prostate cancer in some men becomes androgen-independent (no longer responds to anti-androgen medication), but genetics likely plays an important role.\n* Genes contain the hereditary information that is passed down from parents to children. Although everyone has the same set of genes, individuals can have different forms of the same gene.\n* Differences in genes may explain, at least in part, why some people develop a more aggressive form of prostate cancer than others.\n\nObjectives:\n\n-To obtain blood samples from patients with prostate cancer to try to identify gene differences associated with progression to the androgen independent state.\n\nEligibility:\n\n-All participants participating in NCI prostate cancer protocols.\n\nDesign:\n\n* Participants with prostate cancer are evaluated in the NCI s Medical Oncology Clinic.\n* Blood samples are collected at the initial visit or at follow-up visits.\n* DNA (genetic material) and white blood cells are extracted from these samples to be used for genotyping and establishment of cell lines.\n* Gene variations are correlated with prostate cancer prognosis and prognostic indicators.",[265,27,28,266,267],"Cancer Of Prostate","Metastatic Prostate Cancer","Prostate",[269,28,270,271,272,91,27],"Genetic","Genotyping","Venipuncture","Polymorphism",{"date":228,"type":33},{"date":275,"type":33},"2007-02-28",{"name":98,"class":99},{"id":278,"slug":279,"hasResults":12,"nctId":280,"briefTitle":281,"officialTitle":282,"acronym":4,"eligibilityCriteria":283,"healthyVolunteers":12,"sex":49,"minAge":18,"maxAge":284,"enrollmentInfo":285,"targetDuration":4,"studyType":22,"phases":287,"briefSummary":288,"conditions":289,"keywords":4,"overallStatus":224,"whyStopped":4,"lastUpdateSubmitDate":298,"lastUpdatePostDateStruct":299,"startDateStruct":300,"completionDateStruct":302,"leadSponsor":304,"locationsCount":306},"100643672","phase-2-a-phase-ii-study-of-gv20-0251-in-combination-with-anti-pd-1-monoclonal-antibodies-in-patients-with-unresectable-locally-advanced-or-metastatic-solid-tumors-100643672","NCT07623642","A Phase II Study of GV20-0251 in Combination With Anti-PD-1 Monoclonal Antibodies in Patients With Unresectable, Locally Advanced, or Metastatic Solid Tumors.","An Open-Label, Multicenter, Non-Randomized, Phase II Study of GV20-0251 in Combination With Anti-PD-1 Monoclonal Antibodies in Patients With Unresectable, Locally Advanced, or Metastatic Solid Tumors","Inclusion Criteria\n\n1. Voluntarily signed written informed consent (ICF) prior to any study-specific procedures.\n2. Able and willing to participate in and comply with study procedures throughout the study.\n3. Age ≥ 18 and ≤ 80 years, any gender.\n4. Histologically confirmed unresectable, locally advanced, or metastatic solid tumor.\n5. Must have failed standard of care (SOC), be intolerant to SOC, or be deemed by the investigator to be unsuitable for a specific form of SOC. If SOC failure, documented progression from SOC is required.\n6. No more than 2 prior lines of systemic therapy. Subjects with more lines may be enrolled after sponsor approval. Treatment-naive subjects with locally advanced or metastatic melanoma who have not received systemic therapy may enroll.\n7. Tumor types include: endometrial cancer, cervical cancer, ovarian cancer, triple-negative breast cancer, prostate cancer, head and neck squamous cell carcinoma, esophageal squamous cell carcinoma, hepatocellular carcinoma (HCC), biliary tract malignancies (including only intrahepatic cholangiocarcinoma, extrahepatic cholangiocarcinoma, and gallbladder cancer; excluding ampullary carcinoma), pMMR\u002FMSS colorectal adenocarcinoma, pancreatic ductal adenocarcinoma, non-small cell lung cancer (NSCLC), small cell lung cancer, and melanoma (assessed per local institutional standard practice).\n8. For certain tumor types, IGSF8 protein expression on the tumor cell membrane must be positive at pre-screening or screening.\n9. If the subject has received prior anti-PD-1\u002FPD-L1 therapy, documented disease progression during treatment with anti-PD-1\u002FPD-L1 monoclonal antibody (as monotherapy or combined with other checkpoint inhibitors\u002Ftherapies) is required.\n10. Eligible subjects of childbearing potential (female and male) must agree to use effective contraception (hormonal or barrier method) starting 28 days prior to the first dose of GV20-0251, throughout the treatment period, and for at least 4 months after the last dose.\n11. Must have at least one measurable lesion per RECIST v1.1. Previously irradiated lesions with documented progression may be considered measurable.\n12. Must provide archival tumor tissue collected within 3 years prior to signing the ICF. If archival tissue is \\>3 years old, enrollment requires medical confirmation with the sponsor.\n13. ECOG performance status of 0-1 prior to the first dose on C1D1.\n14. Expected survival ≥ 24 weeks.\n15. No history of other primary malignancies, except: (a) a curatively treated malignancy with no active disease for at least 2 years prior to consent and low risk of subsequent relapse; or (b) curatively treated basal cell or squamous cell carcinoma of the skin, carcinoma in situ of the cervix, or carcinoma in situ of the breast.\n16. Adequate organ, Hepatic, and Coagulation function at screening.\n17. All adverse events related to prior anticancer therapy have resolved to ≤ Grade 1 (per NCI CTCAE v5.0). For persistent Grade 2 toxicities deemed by the investigator unlikely to resolve, eligibility may be discussed with the sponsor.\n18. For HCC or biliary tract malignancy subjects only, as Child-Pugh Class A.\n\nExclusion Criteria\n\n1. Prior immunotherapy discontinued due to ≥ Grade 3 immune-related adverse events (irAEs) - except endocrine disorders manageable with replacement therapy or asymptomatic elevated serum amylase\u002Flipase - Grade 2 myocarditis, or recurrent Grade 2 pneumonitis.\n2. Insufficient washout period from prior systemic anticancer therapy before initiating GV20-0251 and anti-PD-1 therapy (C1D1)\n3. Received radiotherapy within 2 weeks prior to initiating GV20-0251 and anti-PD-1 therapy, or has radiation-related toxicity requiring corticosteroids. For NSCLC subjects: pulmonary radiotherapy \\> 30 Gy within 6 months prior to C1D1.\n4. Currently enrolled in a drug or device clinical trial; or received an investigational device or investigational drug within 4 weeks prior to C1D1.\n5. Diagnosed with immunodeficiency; or currently receiving chronic systemic corticosteroids (\\> 10 mg\u002Fday prednisone equivalent) or any other form of immunosuppressive therapy.\n6. History of gastrointestinal perforation and\u002For fistula within 6 months prior to consent; or active gastric\u002Fduodenal ulcer, ulcerative colitis, or other GI conditions the investigator believes may cause bleeding or perforation.\n7. Clinically significant and\u002For uncontrolled cardiac disease, including NYHA Class III or IV heart failure, uncontrolled hypertension (systolic BP \\> 160 mmHg), clinically significant arrhythmia assessed by the investigator to affect study participation safety, or myocardial infarction within 6 months prior to C1D1.\n8. Severe hypersensitivity reaction (≥ Grade 3) to anti-PD-1 monoclonal antibody and\u002For any of its excipients; or prior severe hypersensitivity to biologic therapies that the investigator considers may increase subject risk.\n9. Acute leukemia or chronic lymphocytic leukemia (CLL).\n10. QTcF \\> 470 msec, or history of congenital long QT syndrome, or clinically significant ECG abnormalities (including pericarditis) that the investigator considers may affect subject safety.\n11. Active infection requiring systemic treatment; or active, uncontrolled bacterial, viral, or fungal infection requiring systemic treatment within 7 days prior to C1D1.\n12. History of (non-infectious) pneumonitis\u002Finterstitial lung disease requiring steroid treatment, or current pneumonitis\u002Finterstitial lung disease.\n13. Active autoimmune disease requiring systemic treatment within 2 years prior to C1D1\n14. HIV infection.\n15. Active HBV or HCV infection\n16. Prior major organ transplantation\n17. Prior autologous or allogeneic bone marrow transplantation.\n18. Symptomatic primary CNS malignancy, CNS metastases, or leptomeningeal disease.\n19. Major surgery (excluding diagnostic procedures) or severe trauma within 28 days prior to the first dose of GV20-0251, or currently in recovery that the investigator deems would interfere with the study, or anticipated major surgery during the study.\n20. Received a live or attenuated vaccine within 30 days prior to the first dose.\n21. Requires treatment with interferon-α or related\u002Fsimilar agents within 3 weeks prior to C1D1 or during the entire study period.\n22. Requires more than one paracentesis per 8 weeks to manage ascites; or single ascites drainage volume \\> 1.5 liters within 8 weeks prior to C1D1.\n23. Psychiatric illness or substance abuse disorder (e.g., drug abuse, alcohol dependence) that may interfere with the subject's ability to comply with study requirements.\n24. Other serious non-malignant conditions or laboratory abnormalities that, in the opinion of the investigator and\u002For sponsor, make the subject unsuitable for the study; or other circumstances that the investigator believes may confound study results or prevent the subject from completing the study.\n25. Additional exclusion criteria that applicable to HCC or biliary tract malignancy subjects.","80 Years",{"count":286,"type":21},227,[54],"This is a Phase 2 study of GV20-0251 in combination with anti-PD-1 monoclonal antibodies (including tislelizumab and toripalimab) for the treatment of participants with unresectable, locally advanced, or metastatic solid tumors who are refractory to, intolerant of, or ineligible for standard of care.",[212,290,28,291,292,293,294,59,295,296,297],"Triple Negative Breast Neoplasms","Squamous Cell Carcinoma of Head and Neck","Esophageal Squamous Cell Carcinoma","Cholangiocarcinoma","Gallbladder Neoplasms","Pancreatic Ductal Adenocarcinoma","Carcinoma, Non-Small-Cell Lung","Small Cell Lung Carcinoma","2026-06-04",{"date":228,"type":33},{"date":301,"type":21},"2026-06-02",{"date":303,"type":21},"2029-08-15",{"name":305,"class":40},"GV20 Therapeutics",2,{"id":308,"slug":309,"hasResults":12,"nctId":310,"briefTitle":311,"officialTitle":312,"acronym":313,"eligibilityCriteria":314,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":315,"targetDuration":4,"studyType":83,"phases":4,"briefSummary":317,"conditions":318,"keywords":320,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":298,"lastUpdatePostDateStruct":323,"startDateStruct":324,"completionDateStruct":326,"leadSponsor":328,"locationsCount":100},"100627620","a-study-to-assess-adherence-to-apalutamide-in-metastatic-hormone-sensitive-prostate-cancer-participants-in-france-100627620","NCT07451002","A Study to Assess Adherence to Apalutamide in Metastatic Hormone-Sensitive Prostate Cancer Participants in France","An OBServational Prospective Study in France: Adherence to APAlutamide in Metastatic Hormone-Sensitive Prostate Cancer (mHSPC) Patients in France","OBSAPA","Inclusion criteria:\n\n* Male (based on chromosomal composition at birth) and aged greater than or equal to (\\>=) 18 years.\n* Must have a histologically or cytologically confirmed diagnosis of prostate adenocarcinoma\n* Must have documented metastatic hormone-sensitive prostate cancer (mHSPC)\n* Must have agreed with the treating physician to initiate treatment with apalutamide (plus androgen-deprivation therapy \\[ADT\\]) in accordance with the current product characteristics summary, based on the physician's decision, prior to study inclusion\n* Able to understand the content of the patient information sheet and has provided oral consent for data collection. Has received the information sheet and has not objected to data collection\n* Must have a baseline prostate-specific antigen (PSA) level collected prior to the first administration of apalutamide.\n* Must agree to complete adherence and quality-of-life questionnaires during the study, including before the first administration of apalutamide\n\nExclusion criteria:\n\n* Has already received or is currently receiving apalutamide, or any other androgen receptor pathway inhibitor (ARPI; including but not limited to abiraterone acetate, darolutamide, and enzalutamide) or chemotherapy for mHSPC\n* Has received an investigational drug (including vaccines) or used an invasive investigational medical device within 90 days prior to study start or data collection\n* Is currently receiving active treatment for prostate cancer as part of an interventional study\n* Has received ADT for mHSPC for more than 4 months prior to starting apalutamide treatment\n* Has experienced progression under ADT (and thus became castration-resistant) before starting apalutamide treatment\n* Beneficiary of State Medical Aid \\[AME\\]\n* Does not speak\u002Fread French\n* Under guardianship or curatorship\n* Under judicial protection",{"count":316,"type":21},270,"This study aims to explore the real-world treatment adherence, persistence of apalutamide, and assess the risk of non-adherence according to the participant's profile and behavior of metastatic hormone-sensitive prostate cancer (mHSPC) participants treated with apalutamide during the first year of continued treatment.",[28,319],"Metastatic Hormone-sensitive Prostate Cancer",[321,322],"Apalutamide","mHSPC",{"date":246,"type":33},{"date":325,"type":33},"2025-12-18",{"date":327,"type":21},"2028-01-03",{"name":329,"class":40},"Janssen Cilag S.A.S.",{"id":331,"slug":332,"hasResults":12,"nctId":333,"briefTitle":334,"officialTitle":335,"acronym":4,"eligibilityCriteria":336,"healthyVolunteers":12,"sex":49,"minAge":18,"maxAge":4,"enrollmentInfo":337,"targetDuration":4,"studyType":22,"phases":339,"briefSummary":340,"conditions":341,"keywords":4,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":298,"lastUpdatePostDateStruct":342,"startDateStruct":343,"completionDateStruct":345,"leadSponsor":347,"locationsCount":71},"100617534","phase-1-a-study-of-pasritamig-jnj-78278343-in-combination-with-jnj-86974680-for-treatment-of-prostate-cancer-100617534","NCT07319871","A Study of Pasritamig (JNJ-78278343) in Combination With JNJ-86974680 for Treatment of Prostate Cancer","A Phase 1b Study of Pasritamig (JNJ-78278343), a T-cell Redirecting Agent Targeting Human Kallikrein 2 (KLK2), in Combination With JNJ-86974680, an A2a Receptor (A2aR) Antagonist, for Prostate Cancer","Inclusion Criteria:\n\n* Histologically confirmed adenocarcinoma of the prostate. Primary small cell carcinoma, carcinoid tumor, neuroendocrine (NE) carcinoma, or large cell NE carcinoma arising in the prostate are not allowed; however, adenocarcinomas with NE features (for example \\[e.g.\\], immunohistochemistry \\[IHC\\] with both androgen receptor \\[AR\\]- and NE-marker positivity) are allowed\n* Metastatic castration-resistant prostate cancer (mCRPC) that is metastatic either to bone, any lymph node, or both without clear evidence of metastasis to visceral organs. Local-regional invasion (rectum, bladder) and bone disease with soft tissue component can be included\n* Prior orchiectomy or medical castration (for example, must be receiving ongoing androgen deprivation therapy with a gonadotropin-releasing hormone \\[GnRH\\] analog \\[agonist or antagonist\\] prior to the first dose of study drug and must continue this therapy throughout the treatment phase)\n* Prostate-specific antigen (PSA) greater than or equal to (\\>=) 2 nanograms per milliliters (ng\u002FmL) at screening\n* Measurable or evaluable disease\n* Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1\n\nExclusion criteria:\n\n* Toxicity related to prior anticancer therapy that has not returned to grade less than or equal to (\\\u003C=) 1 or baseline levels (except for alopecia, neuropathy \\[Grade 2\\] and vitiligo)\n* Known allergies, hypersensitivity, or intolerance to any of the components (for example, excipients) of pasritamig or JNJ-86974680\n* Active infection or condition that requires treatment with systemic antibiotics within 7 days prior to the first dose of study treatment. Antibiotic or antiviral prophylaxis is allowed\n* Have leptomeningeal disease or brain metastases, except participants with definitively, locally treated brain metastases that are clinically stable and asymptomatic \\>2 weeks, and who are off corticosteroid treatment for at least 2 weeks prior to first dose of study treatment\n* Any serious underlying medical conditions or other issue that would impair the ability of the participant to receive or tolerate the planned treatment at the investigational site to understand the informed consent, or any condition for which, in the opinion of the investigator, participation would not be in the best interest of the participant or that could prevent, limit, or confound the protocol-specified assessments",{"count":338,"type":21},40,[53],"The purpose of this study is to identify the recommended phase 2 combination dose (RP2CD) of Pasritamig in combination with JNJ-86974680 in Part 1 (Dose finding) of the study and to determine how safe and tolerable the RP2CD is for treatment of participants with advanced prostate cancer in Part 2 (Dose expansion) of study.",[28],{"date":246,"type":33},{"date":344,"type":33},"2026-01-14",{"date":346,"type":21},"2027-04-30",{"name":348,"class":40},"Janssen Research & Development, LLC",{"id":350,"slug":351,"hasResults":12,"nctId":352,"briefTitle":353,"officialTitle":354,"acronym":4,"eligibilityCriteria":355,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":356,"targetDuration":4,"studyType":22,"phases":358,"briefSummary":359,"conditions":360,"keywords":4,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":298,"lastUpdatePostDateStruct":361,"startDateStruct":362,"completionDateStruct":364,"leadSponsor":366,"locationsCount":367},"100599317","phase-1-a-study-of-jnj-78278343-in-combination-with-jnj-95298177-for-treatment-of-prostate-cancer-100599317","NCT07082920","A Study of JNJ-78278343 in Combination With JNJ-95298177 for Treatment of Prostate Cancer","A Phase 1b Study of JNJ-78278343, a T-cell Redirecting Agent Targeting Human Kallikrein 2 (KLK2), in Combination With JNJ-95298177, an Antibody Drug Conjugate Targeting Prostate Specific Membrane Antigen, for Prostate Cancer","Inclusion Criteria:\n\n* Histologically confirmed adenocarcinoma of the prostate. Primary small cell carcinoma, carcinoid tumor, neuroendocrine (NE) carcinoma, or large cell NE carcinoma arising in the prostate are not allowed; however, adenocarcinomas with NE features (for example \\[e.g.\\], immunohistochemistry \\[IHC\\] with both androgen receptor \\[AR\\]- and NE-marker positivity) are allowed\n* Must have metastatic castration-resistant prostate cancer (mCRPC)\n* PSA must measure at least 2 nanograms per milliliters (ng\u002FmL) at screening\n* Measurable or evaluable disease\n* Prior orchiectomy or medical castration; or, for participants who have not undergone orchiectomy, must be receiving ongoing androgen deprivation therapy with a gonadotropin-releasing hormone (GnRH) analog (agonist or antagonist) prior to the first dose of study drug and must continue this therapy throughout the treatment phase\n* Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1\n\nExclusion criteria:\n\n* Toxicity related to prior anticancer therapy that has not returned to grade less than or equal to (\\\u003C=) 1 or baseline levels (except for alopecia and vitiligo)\n* Known allergies, hypersensitivity, or intolerance to any of the components (e.g., excipients) of JNJ-78278343 or JNJ-95298177\n* Participants with leptomeningeal disease or brain metastases, with the exception of participants with definitively, locally treated brain metastases that are clinically stable and asymptomatic greater than (\\>) 2 weeks, and who are off corticosteroid treatment for at least 2 weeks prior to first dose of study treatment\n* Treatment with any anti-cancer or investigational agents within 14 days prior to the first dose of study treatment; specific requirements for certain anti-cancer therapies are as follows:\n\n  1. Any T-cell redirecting treatment (e.g., CD3-directed bispecific or Chimeric Antigen Receptor T-cell \\[CAR-T\\] therapy) within 90 days prior to the first dose of study treatment\n  2. Immune checkpoint inhibitors within 6 weeks prior to the first dose of study treatment\n  3. Radium (Ra) 223 dichloride within 28 days prior to the first dose of study treatment\n  4. Any prior treatment with kallikrein-related peptidase 2 (KLK2)-targeted therapy\n  5. Any prior prostate-specific membrane antigen (PSMA)-targeting therapy (that is \\[i.e.\\], participants who received PSMA-targeting radioconjugates are excluded) \\[Parts 2A and 2B only\\]. Prior PSMA RLT is allowed in Part 1 and required for Part 2C and Part 2D but last dose must be \\>3 months prior to the first dose of study treatment\n  6. Any prior antibody drug conjugates (ADCs) with microtubule inhibitor payloads (e.g., auristatins, maytansinoids, tubulysins)\n* Any serious underlying medical conditions or other issue that would impair the ability of the participant to receive or tolerate the planned treatment at the investigational site to understand the informed consent, or any condition for which, in the opinion of the investigator, participation would not be in the best interest of the participant or that could prevent, limit, or confound the protocol-specified assessments",{"count":357,"type":21},140,[53],"The purpose of this study is to identify the recommended phase 2 combination dose (RP2CD) of JNJ-78278343 in combination with JNJ-95298177 in Part 1 (Dose confirmation) of the study and to determine how safe and tolerable the RP2CD is for treatment of participants with metastatic castration-resistant prostate cancer (mCRPC; a stage of prostate cancer where the cancer has spread beyond the prostate and is resistant to hormonal therapy) in Part 2 (Dose expansion) of study.",[28],{"date":246,"type":33},{"date":363,"type":33},"2025-07-07",{"date":365,"type":21},"2027-03-01",{"name":348,"class":40},6,{"id":369,"slug":370,"hasResults":12,"nctId":371,"briefTitle":372,"officialTitle":373,"acronym":4,"eligibilityCriteria":374,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":375,"targetDuration":4,"studyType":22,"phases":377,"briefSummary":378,"conditions":379,"keywords":4,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":298,"lastUpdatePostDateStruct":380,"startDateStruct":381,"completionDateStruct":383,"leadSponsor":385,"locationsCount":386},"100523392","phase-1-a-study-of-jnj-87189401-combined-with-jnj-78278343-for-advanced-prostate-cancer-100523392","NCT06095089","A Study of JNJ-87189401 Combined With JNJ-78278343 for Advanced Prostate Cancer","A Phase 1 Study of JNJ-87189401 (PSMA-CD28 Bispecific Antibody) Combined With JNJ-78278343 (KLK2-CD3 Bispecific Antibody) for Advanced Prostate Cancer","Inclusion Criteria:\n\n* Histologically confirmed adenocarcinoma of the prostate. Adenocarcinoma with small cell or neuroendocrine (NE) features is permitted. However, small cell carcinoma, carcinoid tumor, mixed NE carcinoma, or large cell NE carcinoma is disallowed\n* Measurable or evaluable disease per PCWG3 criteria\n* Part 1, Parts 2A, 2B, 3 and 4: Prior orchiectomy or medical castration; participants who have not undergone orchiectomy, must be receiving ongoing androgen deprivation therapy with a gonadotropin releasing hormone (GnRH) analog (agonist or antagonist), prior to the first dose of study drug and must continue this therapy throughout the treatment phase\n* Have an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1\n\nExclusion Criteria:\n\n* History of an autoimmune disease within the 12 months prior to signing consent\n* Any of the following within 6 months prior to signature of informed consent: a. myocardial infarction, b. severe or unstable angina, c. clinically significant ventricular arrhythmias, d. congestive heart failure (New York Heart Association \\[NYHA\\] class II to IV), e. transient ischemic attack, and f. Cerebrovascular accident",{"count":376,"type":21},355,[53],"The purpose of Parts 1, 2A, and 2B of the study is to determine the recommended regimen for Phase 2 (RP2Rs) of combination of JNJ-87189401 with JNJ-78278343 and the purpose of Part 2C of this study is to determine how safe the RP2R(s) of the combination of JNJ-87189401 and JNJ-78278343 is, with or without apalutamide. Part 3 of this study evaluates the safety of the triplet combination of JNJ-87189401 and JNJ-78278343 with standard of care (SOC) lutetium Lu-177 vipivotide tetraxetan. Part 4 of this study further evaluates the safety of the triplet combination of JNJ-87189401 and JNJ-78278343 with JNJ-101556143 in participants with advanced prostate cancer.",[28],{"date":246,"type":33},{"date":382,"type":33},"2023-11-01",{"date":384,"type":21},"2028-06-28",{"name":348,"class":40},15,{"id":388,"slug":389,"hasResults":12,"nctId":390,"briefTitle":391,"officialTitle":392,"acronym":393,"eligibilityCriteria":394,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":395,"targetDuration":4,"studyType":22,"phases":397,"briefSummary":398,"conditions":399,"keywords":4,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":135,"lastUpdatePostDateStruct":400,"startDateStruct":402,"completionDateStruct":404,"leadSponsor":406,"locationsCount":408},"100520458","phase-3-positron-emission-tomography-using-64cu-sar-bispsma-in-participants-with-high-risk-prostate-cancer-prior-to-radical-prostatectomy-100520458","NCT06056830","Positron Emission Tomography Using 64Cu-SAR-bisPSMA in Participants With High-risk Prostate Cancer Prior to Radical Prostatectomy","Positron Emission Tomography Using 64Cu-SAR-bisPSMA in Participants With High-risk Prostate Cancer Prior to Radical Prostatectomy: A Prospective, Single-arm, Multi-center, Blinded-review, Phase 3 Diagnostic Performance Study","CLARIFY","Inclusion Criteria:\n\n* At least 18 years of age.\n* Signed informed consent.\n* Untreated, histologically confirmed adenocarcinoma of the prostate.\n* High-risk or greater PC defined by National Comprehensive Cancer Network Guidelines Version 1.202327 (clinical stage ≥T3a, or Grade Group ≥4, or PSA \\>20 ng\u002FmL).\n* Patients electing to undergo RP with PLND.\n\nExclusion Criteria:\n\n* Administration of any high energy (\\>300 KeV) gamma-emitting radioisotope within 5 physical half-lives prior to Day 1.\n* Known or expected hypersensitivity to 64Cu-SAR-bisPSMA or any of its components.\n* Patients with known predominant small cell or neuroendocrine PC.",{"count":396,"type":21},383,[24],"The aim for this study is to assess the diagnostic performance of 64Cu-SAR-bisPSMA PET to detect regional nodal metastases.",[27,28],{"date":401,"type":33},"2026-05-14",{"date":403,"type":33},"2023-12-21",{"date":405,"type":21},"2026-09",{"name":407,"class":40},"Clarity Pharmaceuticals Ltd",31,{"id":410,"slug":411,"hasResults":12,"nctId":412,"briefTitle":413,"officialTitle":414,"acronym":4,"eligibilityCriteria":415,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":416,"targetDuration":4,"studyType":22,"phases":418,"briefSummary":419,"conditions":420,"keywords":425,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":433,"lastUpdatePostDateStruct":434,"startDateStruct":435,"completionDateStruct":437,"leadSponsor":439,"locationsCount":441},"100471052","phase-1-anti-tumour-activity-of-177lu-rhpsma-101-injection-100471052","NCT05413850","Anti-tumour Activity of (177Lu) rhPSMA-10.1 Injection","An Open-label, Multicentre, Integrated Phase 1 & 2 Study to Evaluate the Safety, Tolerability, Radiation Dosimetry and Anti-tumour Activity of Lutetium (177Lu) rhPSMA-10.1 Injection in Men With Metastatic Castrate-resistant Prostate Cancer","Inclusion Criteria:\n\n1. Male subjects, 18 years of age or older with histologically confirmed adenocarcinoma of the prostate.\n2. Serum testosterone levels \\\u003C50 ng\u002FdL (1.73 nmol\u002FL) after surgical or continued chemical castration.\n3. Presence of disease target or non target lesions (per RECIST v1.1) on CT\u002FMRI and\u002For presence of disease on full body 99mTc bone scan performed within 28 days of screening.\n4. Positive disease expression of PSMA as confirmed on PSMA PET\u002FCT scan.\n5. At least 4 weeks or 5 half-lives (whichever is longer) elapsed between last anti-cancer treatment administration and the initiation of study treatment (except for Luteinising Hormone-releasing Hormone or GnRH).\n6. Resolution of all previous treatment related toxicities to CTCAE version 5.0 grade of ≤1 (except for chemotherapy induced alopecia and grade 2 peripheral neuropathy or grade 2 urinary frequency which are allowed).\n7. Prior major surgery must be at least 12 weeks prior to study entry.\n8. Eastern Cooperative Oncology Group (ECOG) performance status of 0-2 with a life expectancy ≥6 months.\n9. Adequate bone marrow reserve and organ function as demonstrated by blood count, and serum biochemistry at baseline.\n10. Adequate contraception for patients and their partners.\n11. For Phase 1 mCRPC only: Subjects who have experienced disease progression on or after at least 1 NAAD (e.g. abiraterone, enzalutamide) and at least 1 course (but no more than 2 courses) of taxane-based chemotherapy. For Phase 2 mCRPC only: Subjects who have experienced disease progression on or after at least 1 NAAD (e.g. abiraterone, enzalutamide, apalutamide, darolutamide), but have not received previous taxane-based chemotherapy for the treatment of mCRPC.\n\nExclusion Criteria:\n\n1. Known hypersensitivity to the therapeutic or diagnostic IMP or any of its constituents.\n2. Presence of significant PSMA-negative disease on ceCT\u002FMRI scan\n3. Diffuse marrow infiltration of disease ('superscan' appearance on full body 99mTc bone scan).\n4. Symptomatic spinal cord compression, or clinical or radiological findings that are indicative of impending spinal cord compression.\n5. Known history of haematological malignancy.\n6. Known history of central nervous system (CNS) metastases.\n7. Histological findings consistent with neuroendocrine phenotype of prostate cancer.\n8. Known history of other solid malignancy that may reduce life expectancy and\u002For may interfere with disease assessment.\n9. Unresolved urinary tract obstruction defined as radiographic evidence of hydronephrosis with or without ureteric stent\u002Fnephrostomy.\n10. Any uncontrolled significant medical, psychiatric, or surgical condition or laboratory finding that would pose a risk to subject safety or interfere with study participation or interpretation of individual subject results.\n11. Ongoing treatment with bisphosphonates for bone-targeted therapy.\n12. Severe urinary incontinence that would preclude safe disposal of radioactive urine.\n13. Single kidney or renal transplant or any concomitant nephrotoxic therapy that might put the subject at high risk of renal toxicity during the study in the judgement of the investigator.\n14. Clinically significant abnormalities on a single 12 lead electrocardiogram (ECG) at screening.\n15. Previously received external beam irradiation to a field that includes more than 30% of the bone marrow or kidneys.\n16. Previous treatment with any of the following: PSMA targeted radionuclide therapy, Strontium-89, Samarium-153, Rhenium 186, Rhenium-188, Radium-223, hemi-body irradiation.\n17. Subjects with bilateral hip replacements or any significant metallic implants or objects, that may affect image quality and\u002For dosimetry calculations.\n18. Transfusion of blood products for the sole purpose of meeting the eligibility criteria for this clinical study.\n19. Participation in other studies involving IMP(s) within 28 days or 5 half-lives (whichever is longer) prior to study entry and\u002For during study participation.\n20. Any history of clinically significant parenchymal lung disease e.g. interstitial lung disease or bullous emphysema.\n21. Any history of prior thoracic external beam radiotherapy.\n22. Presence of abnormal PSMA PET uptake in the lung parenchyma above expected physiological levels, as determined by local assessment.",{"count":417,"type":21},82,[53,54],"To determine the dose, safety, radiation dosimetry and efficacy of 177Lu-rhPSMA-10.1 in participants with PSMA-expressing metastatic castrate resistant prostate cancer.",[27,421,422,423,28,424],"Metastatic Castration-resistant Prostate Cancer","mCRPC","Urogenital Neoplasms","Prostatic Diseases",[187,422,426,427,428,429,430,431,432],"Prostate cancer","177Lu rhPSMA-10.1","18F-rhPSMA-7.3","BET-PSMA-121","Blue Earth Therapeutics Limited","Radiohybrid","Radiopharmaceuticals","2026-05-12",{"date":401,"type":33},{"date":436,"type":33},"2022-07-20",{"date":438,"type":21},"2028-03-31",{"name":440,"class":40},"Blue Earth Therapeutics Ltd",21,{"id":443,"slug":444,"hasResults":12,"nctId":445,"briefTitle":446,"officialTitle":447,"acronym":4,"eligibilityCriteria":448,"healthyVolunteers":12,"sex":17,"minAge":449,"maxAge":4,"enrollmentInfo":450,"targetDuration":4,"studyType":22,"phases":452,"briefSummary":453,"conditions":454,"keywords":455,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":477,"lastUpdatePostDateStruct":478,"startDateStruct":480,"completionDateStruct":482,"leadSponsor":484,"locationsCount":100},"100636982","low-to-moderate-load-power-training-for-men-with-metastatic-prostate-cancer-100636982","NCT07572760","Low to Moderate Load Power Training for Men With Metastatic Prostate Cancer.","Low to Moderate Load Power Training as an Exercise Intervention for Men With Metastatic Prostate Cancer Undergoing Androgen Deprivation Therapy.","Inclusion Criteria:\n\n* Histopathologically confirmed diagnosis of prostate adenocarcinoma.\n\n  • Metastatic hormone-sensitive prostate cancer (mHSPC), defined as:\n* Presence of metastases at initial diagnosis (synchronous mHSPC), or\n* Development of metastatic disease following prior treatment with curative intent (surgery and\u002For radiotherapy) (metachronous mHSPC).\n\n  * Evidence of progression to castration-resistant prostate cancer (CRPC).\n  * Ongoing treatment with a doublet regimen consisting of standard androgen deprivation therapy (ADT) in combination with an androgen receptor signaling inhibitor (ARSI), initiated prior to study enrollment.\n  * Receipt of bone-protective therapy, including calcium and vitamin D supplementation in combination with bisphosphonates.\n  * Presence of metastatic involvement limited to bone and\u002For lymph nodes.\n  * Functionally independent in activities of daily living.\n\nExclusion Criteria:\n\n* Evidence of visceral metastatic disease.\n* Current or prior treatment with a triplet regimen that includes chemotherapy.\n* History of pathological fracture.","50 Years",{"count":451,"type":21},66,[112],"The goal of this clinical trial is to learn if a low to moderate load power training program is feasible and effective for improving fitness and quality of life of people with prostate cancer under androgen suppression therapy and bone or lymph node metastasis. The main questions it aims to answer are:\n\n* Does a low to moderate load power training program improve quality of life in people with metastatic prostate cancer under androgen deprivation therapy?\n* Does a low to moderate load power training program improve power, strength, endurance, and balance in people with metastatic prostate cancer under androgen deprivation therapy?\n\nResearchers will compare the exercise program with routine care to see if power training works to improve common physical side effects of androgen suppression therapy in patients with metastatic prostate cancer.\n\nParticipants will:\n\n* Participate in a supervised exercise program twice a week for 6 months or maintain routine care.\n* Perform fitness tests and questionnaires about quality of life and mental health.\n* Those who take part in the exercise program will also perform semi-structured in-depth interviews after the end of the program.",[28],[426,456,457,458,459,460,461,462,463,464,465,466,423,467,468,28,469,470,471,472,473,474,475,476],"Strength training","Power training","Quality of life","Mental health","Functional capacity","Exercise","Prostatic","Neoplasm","Androgen","Deprivation","Genital Neoplasms, Male","Genital Diseases","Urogenital Diseases","Motor Activity","Movement","Musculoskeletal Physiological Phenomena","Musculoskeletal and Neural Physiological Phenomena","Metastasis","Metastatic prostate cancer","Androgen deprivation","Testosterone","2026-04-30",{"date":479,"type":33},"2026-05-07",{"date":481,"type":33},"2024-04-10",{"date":483,"type":21},"2026-12-10",{"name":485,"class":140},"University of Alicante",{"id":487,"slug":488,"hasResults":12,"nctId":489,"briefTitle":490,"officialTitle":491,"acronym":492,"eligibilityCriteria":493,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":494,"targetDuration":4,"studyType":83,"phases":4,"briefSummary":496,"conditions":497,"keywords":4,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":499,"lastUpdatePostDateStruct":500,"startDateStruct":502,"completionDateStruct":504,"leadSponsor":506,"locationsCount":100},"100624180","a-study-to-learn-about-real-world-utilization-and-outcomes-of-darolutamide-and-other-androgen-receptor-pathway-inhibitors-arpis-for-newly-diagnosed-metastatic-hormone-sensitive-prostate-cancer-de-novo-mhspc-in-us-urology-clinics-100624180","NCT07406282","A Study to Learn About Real-world Utilization and Outcomes of Darolutamide and Other Androgen Receptor Pathway Inhibitors (ARPIs) for Newly Diagnosed Metastatic Hormone-sensitive Prostate Cancer (de Novo mHSPC) in US Urology Clinics","Double-DARE: Analysis of Doublet and Triplet Therapy With Darolutamide and Other Androgen Receptor Pathway Inhibitors in de Novo mHSPC Patients Seen in Urology Clinics in the USA","Double-DARE","Inclusion Criteria:\n\n* Male patients with evidence of de novo mHSPC during the study period\n* Initiation of ARPI therapy during the patient identification period and within ±90 days from the mHSPC diagnosis\n* Age ≥18 years at index date (ARPI initiation for mHSPC)\n* Initiation of ADT and\u002For docetaxel therapy within ±90 days from index date\n* At least 90 days of EMR activity prior to the index date\n* At least 90 days of EMR activity post-index, unless the patient died earlier.\n\nExclusion Criteria:\n\n* History of other primary cancers (except non-melanoma skin cancer)\n* Use of PARP inhibitors, chemotherapy (other than docetaxel), immunotherapy or radiopharmaceuticals prior to index date\n* Evidence of castration resistance (CR) flag in the database any time before the index date or up to 90 days after the de novo mHSPC diagnosis\n* Clinical trial participation during the study period.",{"count":495,"type":21},1400,"Prostate cancer is the most common non-skin cancer among men in the United States. For some men, the cancer has already spread to other parts of the body at the time of diagnosis; this is called metastatic hormone-sensitive prostate cancer (mHSPC). Treatment for mHSPC has advanced significantly, with new standards of care involving androgen deprivation therapy (ADT) combined with drugs known as androgen receptor pathway inhibitors (ARPIs), sometimes alongside chemotherapy like docetaxel. Darolutamide is an ARPI that is approved by the FDA for treating mHSPC in a \"triplet\" combination with ADT and docetaxel. It is also used in a \"doublet\" combination with ADT alone. However, there is limited information on how darolutamide is used in real-world clinical settings for this condition, which creates a gap in knowledge for making treatment decisions. This study aims to fill that gap by analyzing real-world data from electronic medical records. The primary goal is to describe the characteristics of patients with newly diagnosed mHSPC who are treated with darolutamide (either as a doublet or triplet) in urology clinics across the US. The study will also examine drug use patterns and clinical outcomes for these patients. Additionally, the study will explore the characteristics of patients treated with other ARPIs (abiraterone acetate, enzalutamide, and apalutamide) and assess the feasibility of creating matched patient groups for future comparative research. Data will be collected retrospectively from a large network of community urology practices in the US.",[28,498],"Metastatic Hormone-Sensitive Prostate Cancer","2026-04-08",{"date":501,"type":33},"2026-04-09",{"date":503,"type":33},"2025-07-22",{"date":505,"type":21},"2026-05-31",{"name":507,"class":40},"Bayer",{"id":509,"slug":510,"hasResults":12,"nctId":511,"briefTitle":512,"officialTitle":513,"acronym":4,"eligibilityCriteria":514,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":515,"targetDuration":4,"studyType":22,"phases":517,"briefSummary":518,"conditions":519,"keywords":520,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":526,"lastUpdatePostDateStruct":527,"startDateStruct":529,"completionDateStruct":531,"leadSponsor":533,"locationsCount":100},"100614858","phase-2-diagnostic-utility-of-rhpsma-73-18f-petct-in-men-with-prostate-cancer-on-active-surveillance-100614858","NCT07285057","Diagnostic Utility of rhPSMA-7.3 (18F) PET\u002FCT in Men With Prostate Cancer on Active Surveillance","Diagnostic Utility of rhPSMA-7.3 (18F) PET \u002FCT Imaging in Patients With Prostate Cancer on Active Surveillance","Inclusion Criteria:\n\n* Male participants aged ≥18 years.\n* Histologically confirmed diagnosis of prostate adenocarcinoma.\n* Classified as low-risk or favorable intermediate-risk prostate cancer according to NCCN criteria: Low-risk: Grade Group 1, PSA \\\u003C10 ng\u002FmL, cT1-T2a Favorable intermediate-risk: Grade Group 2, PSA 10-20 ng\u002FmL, cT2b-c Currently managed with active surveillance.\n* Able and willing to undergo rhPSMA-7.3 (¹⁸F) PET\u002FCT imaging, mpMRI, and confirmatory prostate biopsy.\n* Able to provide written informed consent.\n\nExclusion Criteria:\n\n* A history of other active malignancy within the last 5 years, except for non-melanoma skin cancer.\n* Contraindication to 3-T mpMRI.\n* Significant intercurrent morbidity\\*\\* limiting compliance with study protocols.\n\n  \\*\\* Significant intercurrent morbidity refers to a substantial medical condition or complication that arises during a study or treatment, which is severe enough to impact the patient's participation, treatment outcomes, or overall prognosis. These conditions may be unrelated to the primary disease but can influence clinical decision-making, treatment efficacy, and patient safety. Examples include major infections, cardiovascular events, organ failure, or significant worsening of pre-existing comorbidities (https:\u002F\u002Fdoi.org\u002F10.1016\u002FS1053-4296(03)00031-6).\n* History of allergic reactions attributed to compounds of similar chemical or biologic composition to Agent(s) or other agents used in study.",{"count":516,"type":21},120,[54],"This investigator-initiated, prospective study evaluates the diagnostic utility of rhPSMA-7.3 (¹⁸F) PET\u002FCT (flotufolastat F18, marketed as POSLUMA®) in men with biopsy-proven, low-risk or favorable intermediate-risk prostate cancer managed with active surveillance. The study aims to determine whether the addition of PSMA-based PET\u002FCT to standard multiparametric MRI (mpMRI) improves detection of clinically significant prostate cancer compared to MRI alone. Eligible participants will undergo rhPSMA-7.3 (¹⁸F) PET\u002FCT and mpMRI prior to confirmatory prostate biopsy. Biopsies will target areas identified on MRI, PET\u002FCT, or both, and histopathologic outcomes will serve as the reference standard. The study will assess lesion-level concordance between PET\u002FCT, MRI, and pathology, and evaluate the predictive value of PET\u002FCT for disease upgrading. Approximately 120 participants will be enrolled at Mount Sinai Hospital over 12 months. Study participation will involve one imaging visit, one confirmatory biopsy, and follow-up through review of clinical results. There is minimal risk to participants beyond standard diagnostic procedures. The study is funded jointly by the Icahn School of Medicine at Mount Sinai and Blue Earth Diagnostics, which provides the imaging agent flotufolastat F18 and technical support.",[28,27,184],[426,521,522,523,524,525],"Prostatic neoplasms","Active surveillance","PSMA PET\u002FCT","rhPSMA-7.3","Prostate biopsy","2026-02-20",{"date":528,"type":33},"2026-02-23",{"date":530,"type":33},"2026-02-10",{"date":532,"type":21},"2027-05-01",{"name":534,"class":140},"Icahn School of Medicine at Mount Sinai",{"id":536,"slug":537,"hasResults":12,"nctId":538,"briefTitle":539,"officialTitle":539,"acronym":4,"eligibilityCriteria":540,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":541,"targetDuration":4,"studyType":22,"phases":543,"briefSummary":544,"conditions":545,"keywords":4,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":546,"lastUpdatePostDateStruct":547,"startDateStruct":549,"completionDateStruct":551,"leadSponsor":553,"locationsCount":100},"100558152","prostate-adaptive-radiation-therapy-100558152","NCT06547398","Prostate Adaptive Radiation Therapy","Inclusion Criteria:\n\n1. \\- Age \\> 18\n2. Biopsy proven prostate malignancy\n3. Definitive treatment is radiotherapy to the prostate alone\n4. ECOG performance status 0-2\n5. Ability to understand and the willingness to sign an informed consent\n\nExclusion Criteria:\n\n1. Hip prosthesis\n2. Patient separation from prostate centre to skin edge \\> 24cm, measured on diagnostic scan-",{"count":542,"type":21},130,[112],"Prostate ART is a two phase study looking at using adaptive radiotherapy to help reduce toxicity for prostate cancer patients.\n\nAdaptive radiotherapy is a new technology that provides the ability to account for daily changes in anatomy. Adaptive radiotherapy also provides a foundation for which radiotherapy margins might be safely reduced.\n\nPhase 1 of this study is looking to see if a radiation therapist centred adaptive workflow can be implemented. If phase 1 of this study is safe and feasible, the study will proceed to phase 2.\n\nPart 2 of the study looks at using adaptive technology to reduce radiation treatment margins. The primary aim of this study is to see whether margin reduced treatment using adaptive radiotherapy can reduce side effects for prostate cancer patients.",[28],"2026-02-03",{"date":548,"type":33},"2026-02-05",{"date":550,"type":33},"2025-10-01",{"date":552,"type":21},"2031-10-31",{"name":554,"class":140},"Royal North Shore Hospital",{"id":556,"slug":557,"hasResults":12,"nctId":558,"briefTitle":559,"officialTitle":560,"acronym":561,"eligibilityCriteria":562,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":563,"targetDuration":4,"studyType":22,"phases":565,"briefSummary":566,"conditions":567,"keywords":4,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":571,"lastUpdatePostDateStruct":572,"startDateStruct":574,"completionDateStruct":576,"leadSponsor":578,"locationsCount":100},"100618715","men-with-prostate-cancer-optimizing-wellness-by-enhanced-relief-from-hot-flashes-with-acupuncture-100618715","NCT07335224","Men With Prostate Cancer: Optimizing Wellness by Enhanced Relief From Hot Flashes With Acupuncture","MPOWER: A Pilot Trial Among Men With Prostate Cancer: Optimizing Wellness by Enhanced Relief From Hot Flashes With Acupuncture","MPOWER","Inclusion Criteria:\n\n* Male\n* At least 18 years of age\n* Histologically or cytologically confirmed adenocarcinoma of prostate of any stage I-IV\n* Undergoing androgen deprivation therapy (ADT) and\u002For androgen receptor pathway inhibitors\n* Experiencing moderate to severe daily interference from hot flashes, as indicated by the Hot Flash Related Daily Interference Scale (score≥4)\n* Eastern Cooperative Oncology Group (ECOG) performance status of 0-1\n* Able to read, understand, and provide written informed consent\n\nExclusion Criteria:\n\n* Severe or uncontrolled concurrent disease, infection or co-morbidity that, in the opinion of the Investigator, would make the patient inappropriate for enrollment\n* Known hypersensitivity to the acupuncture needles\n* Any condition that in the opinion of the Investigator would impair the patients' ability to comply with the study procedures\n* Unable to comply with study requirements\n* Use of acupuncture for hot flashes within 6 months prior to enrollment",{"count":564,"type":21},24,[112],"Prostate cancer is the most common cancer among men in the United States. Many men with prostate cancer are treated with hormone therapy, also called androgen deprivation therapy (ADT). While this treatment is effective, it often causes bothersome side effects such as hot flashes, poor sleep, fatigue, and other physical and emotional symptoms. There is currently no standard treatment to help manage these side effects in men. Acupuncture is a non-drug treatment that has been shown to help reduce hot flashes and related symptoms in women receiving hormone therapy for breast cancer. However, much less is known about whether acupuncture is helpful for men receiving hormone therapy for prostate cancer. This study will test whether an acupuncture program, combined with usual lifestyle education, is feasible and acceptable for men undergoing ADT. The study will also explore whether acupuncture may help reduce hot flashes and improve related symptoms. A total of 24 men with prostate cancer receiving ADT will be randomly assigned to one of two groups: one group will begin acupuncture right away, and the other group will begin acupuncture after a delay, with regular check-ins during the waiting period. All participants will receive standard lifestyle education. Participants will be followed for about five months and will be asked to complete daily hot flash diaries, questionnaires about their symptoms and quality of life, and wear a Fitbit to track sleep. The results of this pilot study will help determine whether a larger study should be conducted to better understand the role of acupuncture in managing hormone therapy side effects in men with prostate cancer.",[568,569,570,124,28],"Hot Flashes","Acupuncture Therapy","Vasomotor Symptoms","2026-02-02",{"date":573,"type":33},"2026-02-04",{"date":575,"type":33},"2026-01-08",{"date":577,"type":21},"2027-06-30",{"name":579,"class":140},"Inova Health Care Services",{"id":581,"slug":582,"hasResults":12,"nctId":583,"briefTitle":584,"officialTitle":585,"acronym":4,"eligibilityCriteria":586,"healthyVolunteers":12,"sex":49,"minAge":18,"maxAge":4,"enrollmentInfo":587,"targetDuration":4,"studyType":83,"phases":4,"briefSummary":589,"conditions":590,"keywords":594,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":597,"lastUpdatePostDateStruct":598,"startDateStruct":600,"completionDateStruct":602,"leadSponsor":604,"locationsCount":306},"100459570","lymphedema-after-urologic-surgery-100459570","NCT05264337","Lymphedema After Urologic Surgery","Lymphedema in the Lower Extremities After Urologic Surgery With Lymph Node Dissection","Inclusion Criteria:\n\n* Patients undergoing urologic surgery with lymph node dissection\n\nExclusion Criteria:\n\n* None",{"count":588,"type":21},400,"Lymphedema of the extremities is common after lymph node surgery in treating several forms of cancer, e.g., breast cancer. However, very little is known of the occurrence of lymphedema of the lower extremities after urologic surgery with lymph node dissection. This project aims to describe the frequency and grade of lymphedema arising after urologic surgery, using the Lymphedema Quality of Life Questionnaire (LymQOL), Delfin MoistureMeter D, and lower limb volume measurements.",[591,28,592,593],"Urinary Bladder Neoplasms","Testicular Neoplasms","Penile Cancer",[595,596],"Lymphedema","Lymph Node Excision","2026-01-15",{"date":599,"type":33},"2026-01-16",{"date":601,"type":33},"2022-03-14",{"date":603,"type":21},"2030-01",{"name":605,"class":606},"Vastra Gotaland Region","OTHER_GOV",{"id":608,"slug":609,"hasResults":12,"nctId":610,"briefTitle":611,"officialTitle":612,"acronym":613,"eligibilityCriteria":614,"healthyVolunteers":12,"sex":17,"minAge":204,"maxAge":4,"enrollmentInfo":615,"targetDuration":4,"studyType":83,"phases":4,"briefSummary":617,"conditions":618,"keywords":619,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":622,"lastUpdatePostDateStruct":623,"startDateStruct":624,"completionDateStruct":626,"leadSponsor":628,"locationsCount":630},"100114562","prostate-active-surveillance-study-100114562","NCT00756665","Prostate Active Surveillance Study","Canary Prostate Active Surveillance Study","PASS","Inclusion Criteria:\n\n* Histologically confirmed adenocarcinoma of the prostate from a prostate biopsy.\n* Clinically localized prostate cancer: T1-2, NX or N0, MX or M0.\n* No previous treatment for prostate cancer (including hormonal therapy, radiation therapy, surgery, or chemotherapy).\n* ECOG Performance Status 0 or 1.\n* Patient has elected Active Surveillance as preferred management plan for prostate cancer.\n* Patient consent has been obtained according to local Institutional Review Board for acquisition of research specimens.\n* Patient is accessible and compliant for follow-up.\n* Prostate cancer diagnosis cannot be more than 3 years prior to baseline visit date.\n* No more than two prostate biopsies including the initial biopsy in which cancer was diagnosed.\n* If cancer diagnosis is more than one year before enrollment, there must be two prostate biopsies including the initial biopsy in which cancer was diagnosed and a subsequent biopsy. The subsequent biopsy may occur on the same day as the baseline visit.\n* Biopsies must have at least 10 cores.\n\nExclusion Criteria:\n\n* Unwillingness or inability to undergo serial prostate biopsy.\n* History of other malignancies, except: adequately treated non-melanoma skin cancer or adequately treated superficial bladder cancer (Ta) or other solid tumors curatively treated with no evidence of disease for \\> 5 years.",{"count":616,"type":21},3000,"The Prostate Active Surveillance Study (PASS) is a research study for men who have chosen active surveillance as a management plan for their prostate cancer. Active surveillance is defined as close monitoring of prostate cancer with the offer of treatment if there are changes in test results. This study seeks to discover markers that will identify cancers that are more aggressive from those tumors that grow slowly.",[28],[620,621],"prostate","cancer","2026-01-13",{"date":597,"type":33},{"date":625,"type":4},"2008-07",{"date":627,"type":21},"2032-09",{"name":629,"class":140},"University of Washington",11,{"id":632,"slug":633,"hasResults":12,"nctId":634,"briefTitle":635,"officialTitle":636,"acronym":4,"eligibilityCriteria":637,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":638,"targetDuration":4,"studyType":22,"phases":640,"briefSummary":641,"conditions":642,"keywords":643,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":645,"lastUpdatePostDateStruct":646,"startDateStruct":648,"completionDateStruct":650,"leadSponsor":652,"locationsCount":654},"100498072","phase-2-recoverpc-relugolix-vs-gnrh-agonist-in-quality-of-life-100498072","NCT05765500","RecoverPC: Relugolix vs GnRH Agonist in Quality of Life","RecoverPC: A Phase 2 Study of RElugolix Versus GnRH Agonist Quality of Life (QOL) and Testosterone reCOVERy in Men With Prostate Cancer","Inclusion Criteria:\n\n* Participants must have a histologic diagnosis of prostate adenocarcinoma.\n* Participants must be eligible for treatment with 6 months of ADT with leuprolide depot or relugolix without additional systemic therapies other than first generation androgen receptor antagonists (eg. bicalutamide, nilutamide, flutamide).\n* Participants cannot have received prior GnRH agonist or antagonist therapy.\n* Patients must have testosterone level \\> 200 ng\u002FmL prior to initiation of ADT.\n* Age ≥18 years.\n* ECOG performance status ≤2 (Karnofsky ≥60%, see Appendix A).\n* Life expectancy of greater than 12 months\n* Participants must have adequate organ and marrow function as defined below:\n\n  * leukocytes ≥3,000\u002FmcL\n  * absolute neutrophil count ≥1,500\u002FmcL\n  * platelets ≥100,000\u002FmcL\n  * total bilirubin ≤ institutional upper limit of normal (ULN) unless known or suspected Gilbert syndrome\n  * AST(SGOT)\u002FALT(SGPT) ≤3 × institutional ULN\n  * creatinine ≤ institutional ULN OR\n  * glomerular filtration rate (GFR) ≥50 mL\u002Fmin\u002F1.73 m2 unless data exists supporting safe use at lower kidney function values, no lower than 30 mL\u002Fmin\u002F1.73 m2 (see Appendix B).\n* Human immunodeficiency virus (HIV)-infected participants on effective anti-retroviral therapy with undetectable viral load within 6 months are eligible for this trial.\n* For participants with evidence of chronic hepatitis B virus (HBV) infection, the HBV viral load must be undetectable on suppressive therapy, if indicated.\n* Participants with a history of hepatitis C virus (HCV) infection must have been treated and cured. For participants with HCV infection who are currently on treatment, they are eligible if they have an undetectable HCV viral load.\n* Participants with a prior or concurrent malignancy whose natural history or treatment does not have the potential to interfere with the safety or efficacy assessment of the investigational regimen are eligible for this trial.\n* Participants with known history or current symptoms of cardiac disease, or history of treatment with cardiotoxic agents, should have a clinical risk assessment of cardiac function using the New York Heart Association Functional Classification. To be eligible for this trial, participants should be class 2B or better.\n* The effects of relugolix and leuprolide on the developing human fetus are unknown. For this reason and because GnRH agents are known to be teratogenic, women of child-bearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry and for the duration of study participation. Should a woman become pregnant or suspect she is pregnant while she or her partner is participating in this study, she should inform her treating physician immediately. Men treated or enrolled on this protocol must also agree to use adequate contraception prior to the study, for the duration of study participation, and 4 months after completion of relugolix or leuprolide depot administration.\n* Ability to understand and the willingness to sign a written informed consent document.\n\nExclusion Criteria:\n\n* History of major adverse cardiac event, including myocardial infarction, new congestive heart failure (CHF) or CHF exacerbation, or stroke, within the past 6 months.\n* Participants who have prior or planned concurrent treatment with second generation AR targeted therapies (such as abiraterone, enzalutamide, darolutamide, apalutamide).\n* Participants who are receiving any other investigational agents.\n* Patients with brain metastases will be excluded from the study as intermittent hormonal therapy is not standard of care treatment for this population.\n* History of allergic reactions attributed to compounds of similar chemical or biologic composition to leuprolide depot or relugolix.\n* Participants with uncontrolled intercurrent illness.\n* Participant is unable to swallow pills.",{"count":639,"type":21},110,[54],"This study is testing the way that approved androgen deprivation therapy treatments, Leuprolide and Relugolix, for prostate cancer affect quality of life, blood levels, cholesterol, and blood sugar. The drugs are already standard treatment for people with prostate cancer, and the drugs will be used as described in their label.\n\nThe names of the study drugs involved in this study are:\n\n* Leuprolide (type of ADT)\n* Relugolix (type of ADT)",[27,28],[27,644],"Prostate Neoplasms","2025-08-05",{"date":647,"type":33},"2025-08-11",{"date":649,"type":33},"2024-02-12",{"date":651,"type":21},"2028-01-01",{"name":653,"class":140},"Dana-Farber Cancer Institute",3]