[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"high-risk-prostate-cancer\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:high-risk-prostate-cancer":27},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,13,0,[8,46,82,110,138,166,199,225,252,278,299,326,357],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":18,"targetDuration":4,"studyType":21,"phases":22,"briefSummary":24,"conditions":25,"keywords":28,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":34,"lastUpdatePostDateStruct":35,"startDateStruct":38,"completionDateStruct":40,"leadSponsor":42,"locationsCount":45},"100595028","phase-2-neoadjuvant-adt--darolutamide-with-pembrolizumab-followed-by-adjuvant-pembrolizumab-in-molecularly-stratified-high-risk-prostate-cancer-100595028",false,"NCT07027124","Neoadjuvant ADT + Darolutamide With Pembrolizumab, Followed by Adjuvant Pembrolizumab in Molecularly Stratified High-Risk Prostate Cancer","Neoadjuvant ADT and Darolutamide With Pembrolizumab, Followed by Adjuvant Pembrolizumab in NCCN High-risk and Molecularly Stratified Prostate Cancer Patients","Inclusion Criteria:\n\n* Male Age ≥ 18 years at the time of consent\n* Subjects must have histopathologically confirmed adenocarcinoma of the prostate\n* Subjects must have unfavorable intermediate and high-risk localized or locally advanced prostate cancer (Gleason score ≥7 (4+3) and absence of distant metastasis or non-regional nodal involvement.\n* Subjects must be risk-stratified at biopsy and their cancer should have all the molecular features given below at baseline.\n\n  1. Decipher Genomic Classifier \\>0.45 (interpreted from decipher report) and\u002F or\n  2. Luminal B subtype (interpreted from decipher report).\n* The patient must have a performance status of 0-1 as determined by criteria set forward by the eastern cooperative oncology group.\n* Subjects with prior neoadjuvant hormonal therapy are allowed if they meet the following criteria.\n\n  * have completed all treatments ≥ 12, months ago.\n  * Recovered from all AEs due to previous therapies.\n* If subject has had a major surgery, he should have recovered from all complications and toxicities prior to enrolling in the study.\n* Adequate organ and marrow function as defined below:\n\n  * Hematological\n  * Absolute neutrophil count (ANC) ≥ 1,500\u002FmcL\n  * Platelets ≥ 100,000\u002Fmcl\n  * Hemoglobin (Hb) ≥ 9 g\u002FdL Hepatic\n  * total bilirubin ≤ 1.5 mg\u002Fdl (except in patients with gilbert syndrome who can have total bilirubin \\\u003C3.0 mg\u002Fdl)\n  * Aspartate aminotransferase (AST) ≤ 2.5 x ULN\n  * Alanine aminotransferase (ALT) ≤ 2.5 x ULN Renal\n  * Creatinine OR Creatinine ≤ 1.5 ULN OR\n  * Calculated creatinine clearance Creatinine clearance ≥ 30 ml\u002Fmin\n  * Men must agree to use a condom and not father a child or donate sperm for the duration of the study and for 90 days after completion of therapy. Subject must agree to partner use of an additional contraceptive method when having intercourse with women of childbearing potential (WOCBP).\n  * Ability to understand and the willingness to sign a written informed consent.\n  * Subjects who are HBs Ag positive are eligible if they have received HBV anti-viral therapy for at least 4 weeks and have undetectable HBV viral load prior to randomization.\n\nNote: Subjects should remain on anti-viral therapy throughout study intervention and follow local guidelines for HBV anti-viral therapy post completion of study intervention.\n\n* Hepatitis B screening tests are not required unless:\n\n  * Known history of HBV infection\n  * As mandated by local health authority\n* Subjects with a history of HCV infection are eligible if HCV viral load is undetectable at screening.\n\nNote: Subjects must have completed curative anti-viral therapy at least 4 weeks prior to randomization.\n\n* Hepatitis C screening tests are not required unless:\n\n  * Known history of HCV infection\n  * As mandated by local health authority\n* Subjects with a known history of Human immunodeficiency virus (HIV) infection are eligible as long as they have an undetectable viral. HIV positive participants must be taking stable ART for ≥ 12 weeks and have an undetectable HIV viral load within 28 days before enrollment. Minor fluctuations up to 200 copies\u002FmL are acceptable.\n\nExclusion Criteria:\n\n* Subjects with metastatic disease\n* Subjects with Gleason score ≤7 (3+4)\n* Subjects with Biopsy Decipher score ≤0.45.\n* Subjects have had prior hormonal therapy (please see inclusion criteria for exceptions).\n* Subjects have had prior radiation therapy or chemotherapy for prostate cancer.\n* Subjects with active cardiac disease defined as having any of the following within 6 months prior to the start of treatment:\n\n  * myocardial infarction,\n  * severe\u002Funstable angina pectoris,\n  * congestive heart failure,\n  * hospitalization for any cardiac event\n* Subject has active GI disorder that will interfere with absorption of study drug Darolutamide Subject has prior treatment with androgen receptor inhibitors, such as apalutamide, Darolutamide, enzalutamide, abiraterone acetate or other investigational CYP17 inhibitor.\n* Inability to swallow oral medications.\n* Subject has active infection requiring systemic therapy within 7 days of Week 1.\n* Subject has received prior therapy with anti-PD1, anti-PDL1, anti-PDL2 or with other checkpoint inhibitors or T-cell costimulatory\u002Finhibitory agents (e.g., CD137, OX-40, CTLA4).\n* Subject with an active viral Hepatitis B (defined as Hepatitis B surface antigen \\[HBsAg\\] reactive or detectable \\[qualitative\\] Hepatitis b virus \\[HBV\\] DNA or defined as Hepatitis V virus \\[HCV\\] ribonucleic acid \\[RNA\\] \\[qualitative\\] is detected), known Human Immunodeficiency virus (HIV) infection with detectable viral load, or chronic liver disease with a need of treatment.\n* Subject has a known active or known history of TB (Bacillus tuberculosis) or active history of non-infectious pneumonitis.\n* Subject who are immunodeficient or are receiving chronic systemic steroid therapy (in dosing exceeding 10 mg daily of prednisone equivalent) or any other form of immunosuppressive therapy within 7 days of study intervention. Topical or inhaled steroids are permitted in absence of immunodeficiency or autoimmune disease.\n* Subject have active auto-immune disease that has required systemic therapy (use of disease modifying agents, corticosteroids, or immunosuppressive drugs) in the past 2 years. However, subjects receiving replacement therapy (e.g., insulin, thyroxine, or physiological corticosteroid replacement therapy for adrenal and pituitary insufficiency) are eligible.\n* Has history or current evidence of any condition, therapy that might confound results of the study. - Has known psychiatric, epileptic or substance abuse history or disorder that would interfere with participant's ability to cooperate with the requirements of the study.\n* Subjects with known brain metastases should be excluded from this clinical trial because of their poor prognosis and because they often develop progressive neurologic dysfunction that would confound the evaluation of neurologic and other adverse events.\n* Known history of allergic reactions attributed to compounds of similar chemical or biologic composition to Agent(s) or other agents used in study.","MALE","18 Years",{"count":19,"type":20},40,"ESTIMATED","INTERVENTIONAL",[23],"PHASE2","This is a single-arm, phase II study of neoadjuvant combination therapy of Androgen Deprivation Therapy (ADT), \\[Gonadotropin-Releasing Hormone (GnRH) agonist Leuprolide\\], androgen receptor (AR)-antagonist Darolutamide and Pembrolizumab in a stratified high-risk localized prostate cancer cohort, followed by adjuvant treatment with Pembrolizumab (12 cycles) post-radical prostatectomy (RP).\n\nPatients with National Comprehensive Cancer Network (NCCN) high-risk non-metastatic prostate cancer (localized or locally advanced) (defined as Gleason ≥8, disease stage \\>=cT3a, or PSA l \\>20 ng\u002FmL) will be risk-stratified at a biopsy using Decipher, a commercial standard-of-care diagnostic assay. Patients satisfying all three criteria of high-risk genomic characteristics listed below as per the Decipher grid results will be enrolled in the study:\n\n1. Decipher Genomic classifier, GC\\>0.6\n2. AR activity score\u002FAR-output gene signature (ARoS)\\>11.0\n3. High Luminal B score\u002F PAM50 subtype signature",[26,27],"Prostate Cancer","High-risk Prostate Cancer",[26,29,30,31,32],"Immunotherapy","Pembrolizumab","Darolutamide","ADT","RECRUITING","2026-06-12",{"date":36,"type":37},"2026-06-16","ACTUAL",{"date":39,"type":20},"2026-05-21",{"date":41,"type":20},"2031-05-02",{"name":43,"class":44},"Icahn School of Medicine at Mount Sinai","OTHER",1,{"id":47,"slug":48,"hasResults":11,"nctId":49,"briefTitle":50,"officialTitle":51,"acronym":52,"eligibilityCriteria":53,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":54,"targetDuration":4,"studyType":21,"phases":56,"briefSummary":57,"conditions":58,"keywords":61,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":72,"lastUpdatePostDateStruct":73,"startDateStruct":75,"completionDateStruct":77,"leadSponsor":79,"locationsCount":81},"100623225","phase-2-androgen-responsive-posluma-guided-intra-prostatic-boost-100623225","NCT07393867","Androgen-responsive POSLUMA-guided Intra-prostatic Boost","Androgen-responsive POSLUMA-guided Intra-prostatic Boost (ARPEGGIO)","ARPEGGIO","Inclusion Criteria:\n\n* 18 years of age and older.\n* Eastern Oncology Group Status 0 to 1.\n* Histologic diagnosis of prostate cancer.\n* Prior screening MRI with at least one PI-RADS4 or PI-RADS 5 lesion, obtained within 180 days of screening.\n* NCCN intermediate-risk or high-risk prostate cancer (Appendix B). All patients will be staged by MRI.\n* Prior PSMA PET scan with at least one focal avid lesion greater than background prostate that is concordant with a lesion on MRI, obtained within 180 days of screening.\n* Intention for SBRT (36.25 Gy\u002F5 fraction) with focal boost (up to 50 Gy) to one MRI\u002FPET-concordant lesion34.\n\nExclusion Criteria:\n\n* Prior imaging (CT, bone scan, MRI, PSMA-PET\u002FCT) showing nodal or distant disease.\n* Intention to receive treatment intensification with secondary androgen receptor signaling inhibitors or chemotherapy.\n* Clinical T4 disease.\n* Prior ADT.\n* Prior pelvic RT.\n* Prior prostate surgery, including TURP.\n* International prostate symptom score \\> 20.\n* Prior urethral stricture.\n* Prostate volume \\> 80 cc on MRI.\n* Hip implants that cause artifacts over the prostate gland.\n* Inability to discontinue anti-coagulation for fiducial marker placement.\n* Active Crohn's disease or scleroderma.",{"count":55,"type":20},23,[23],"This research study is for men with intermediate- or high-risk prostate cancer who are planning to receive hormone therapy and radiation treatment. The purpose of the study is to see whether a special type of diagnostic imaging done during hormone therapy can help doctors more accurately target remaining cancer with radiation, while avoiding areas that may no longer need extra treatment. All participants will receive standard hormone therapy and radiation therapy, along with three imaging scans, over a six-month period. The information gained from this study may help make prostate cancer radiation treatment more precise and reduce side effects for future patients.",[59,60,26],"Intermediate Risk Prostate Cancer","High Risk Prostate Cancer",[62,63,64,65,66,67,68,69,70,71],"POSLUMA","prostate-specific membrane antigen positron-emission tomography","PSMA-PET\u002FCT","18F-flotufolastat-PSMA-PET\u002FCT scan","ADT and 18F-flotufolastat-guided focal SBRT microboost","androgen deprivation therapy and 18F-flotufolastat-guided focal SBRT microboost","neoadjuvant ADT","neoadjuvant androgen deprivation therapy","neoadjuvant ADT prior to SBRT","18F-flotufolastat-PET\u002FCT scans for intermediate and high risk prostate cancer","2026-05-27",{"date":74,"type":37},"2026-05-29",{"date":76,"type":37},"2026-04-29",{"date":78,"type":20},"2027-12-15",{"name":80,"class":44},"Martin T. King, MD, PhD",4,{"id":83,"slug":84,"hasResults":11,"nctId":85,"briefTitle":86,"officialTitle":87,"acronym":88,"eligibilityCriteria":89,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":90,"targetDuration":4,"studyType":21,"phases":92,"briefSummary":94,"conditions":95,"keywords":96,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":76,"lastUpdatePostDateStruct":102,"startDateStruct":104,"completionDateStruct":106,"leadSponsor":108,"locationsCount":45},"100607518","phase-iii-adaptive-adaptive-stereostactic-body-radiotherapy-sbrt-with-dose-escalation-for-high-risk-prostate-cancer-100607518","NCT07189598","Phase III Adaptive Adaptive Stereostactic Body Radiotherapy (SBRT) With Dose Escalation for High-Risk Prostate Cancer","Phase III Study of Adaptive Stereostactic Body Radiotherapy With Dose-escalation on the Dominant Intraprostatic Lesion for High-risk Prostate Cancer: ORION Trial Protocol","ORION","Inclusion Criteria:\n\n* Male.\n* Age ≥ 18 years\n* ECOG (Eastern Cooperative Oncology Group) performance status 0-2\n* Histologically proven prostate adenocarcinoma, not previously treated\n* High-risk or very high-risk according to the National Comprehensive Cancer Network (NCCN) :\n\n  * T3a \u002F T3b (proximal extension only),\n  * and\u002For ISUP (International Society of Urological Pathology) grade 4-5,\n  * and\u002For PSA (Prostate-Specific Antigen) 20ng\u002FmL\n* Non-metastatic, as proven by Prostate Specific Membrane Antigen (PSMA) positron emission tomography\u002Fcomputed tomography (PET\u002FCT) and pelvic MRI (Magnetic Resonance Imaging) less than 2 months before starting hormone therapy\n* Normal testosterone levels prior to hormone therapy\n* Ability to give consent for inclusion in the study\n* Acceptance of treatment and monitoring modalities\n\nExclusion Criteria:\n\n* Presence of nodal or distant metastases\n* Stage T4.\n* Prostate volume \\> 80 cm3.\n* IPSS \\>19\u002F35.\n* Previous local treatment of prostate adenocarcinoma (HIFU (High-Intensity Focused Ultrasound), cryotherapy)\n* Previous TransUrethral Resection of the prostate (PTUR)).\n* Previous pelvic radiotherapy.\n* Chronic inflammatory bowel disease.\n* Active cardiovascular comorbidities (e.g. myocardial infarction or ischemic stroke within the last 6 months).",{"count":91,"type":20},390,[93],"NA","The aim of this clinical trial is to evaluate the efficacy of adaptive prostate Stereotatic Body RadioTherapy (SBRT), which integrates both Whole Pelvic RadioTherapy (WPRT) and dose escalation on the Dominant Intraprostatic Lesion (DIL), compared with standard radiotherapy. This will be assessed using a 5-year cost-utility analysis based on data from the clinical trial and the National Health Data System (NHDS).",[60],[97,98,99,100,101],"phase III","stereotactic body radiotherapy","prostate cancer","high-risk","randomized clinical trial",{"date":103,"type":37},"2026-04-30",{"date":105,"type":37},"2026-03-02",{"date":107,"type":20},"2033-04-01",{"name":109,"class":44},"Center Eugene Marquis",{"id":111,"slug":112,"hasResults":11,"nctId":113,"briefTitle":114,"officialTitle":115,"acronym":116,"eligibilityCriteria":117,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":118,"targetDuration":4,"studyType":120,"phases":4,"briefSummary":121,"conditions":122,"keywords":126,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":128,"lastUpdatePostDateStruct":129,"startDateStruct":131,"completionDateStruct":133,"leadSponsor":135,"locationsCount":137},"100635522","serial-psma-pet-for-therapy-monitoring-in-clinically-significant-prostate-cancer-100635522","NCT07553780","Serial PSMA PET for Therapy Monitoring in Clinically Significant Prostate Cancer","Serial PSMA PET for Treatment Response Monitoring in Newly Diagnosed Clinically Significant, Treatment-Naïve Prostate Cancer - A Prospective, Multicenter Study","PSMA-TM","Inclusion Criteria\n\n1. Newly diagnosed, histologically confirmed prostate cancer with Gleason score ≥7 (clinically significant prostate cancer).\n2. Planned to receive curative-intent therapy (radical prostatectomy or radiotherapy) or systemic therapy (androgen deprivation therapy, chemotherapy, or combination).\n3. Undergo baseline PSMA PET\u002FCT imaging prior to any prostate cancer-related treatment.\n4. Age ≥18 years.\n5. Willing and able to comply with the follow-up schedule, including the second PSMA PET\u002FCT scan.\n6. Provide written informed consent.\n\nExclusion Criteria\n\n1. Any prior prostate cancer treatment (including hormonal therapy, radiotherapy, chemotherapy, or surgery) before baseline PSMA PET\u002FCT.\n2. Contraindications to PSMA PET\u002FCT imaging (e.g., known severe allergic reaction to radiotracer components, inability to lie flat for the duration of the scan).\n3. Other active malignancy within the past two years, excluding non-melanoma skin cancer.\n4. Severe comorbidities or conditions that, in the opinion of the investigator, could interfere with study compliance or pose a significant risk to the patient.\n5. Unable or unwilling to provide informed consent.",{"count":119,"type":20},110,"OBSERVATIONAL","This prospective, multicenter study aims to evaluate the clinical utility of serial PSMA PET for therapy monitoring in patients with newly diagnosed clinically significant prostate cancer.\n\nClinically significant prostate cancer is defined as Gleason score ≥7.Patients will undergo baseline PSMA PET\u002FCT prior to any treatment. A second PSMA PET\u002FCT will be performed either at PSA recurrence (PSA rise ≥2 ng\u002FmL above nadir after radiotherapy or biochemical progression per PCWG3 criteria) or at a fixed time window of 12-24 months after treatment completion for those without biochemical recurrence.\n\nPrimary Outcome:\n\n1\\. Absolute and relative change in SUVmax from baseline to follow-up PSMA PET, correlated with treatment response categories (complete response, partial response, stable disease, progressive disease) defined by a composite reference standard (PSA kinetics, conventional imaging, clinical outcomes).\n\n\\[Time Frame: Baseline and follow-up (up to 24 months)\\]\n\nSecondary Outcomes:\n\n1. Absolute and relative change in the number of PSMA-avid lesions (primary tumor, nodal, bone metastases) as a supportive exploratory endpoint.\n2. Proportion of patients with treatment strategy change following serial PSMA PET.\n3. Agreement between PSMA PET response (≥30% decrease in SUVmax) and PSA50 response (≥50% PSA decline) using Cohen's kappa.\n4. Agreement between PSMA PET response and PSA90 response (≥90% PSA decline).\n5. Prognostic value of baseline and follow-up PSMA PET parameters for progression-free survival (PFS).\n6. Prognostic value of baseline and follow-up PSMA PET parameters for time to castration resistance (ADT-treated patients only).\n7. Subgroup analyses by treatment type (radiotherapy, ADT, chemotherapy), baseline disease burden (oligometastatic vs. polymetastatic), and Gleason grade group (≤7 vs. ≥8).\n8. Inter-reader agreement for PSMA-avid lesion counts. \\[Time Frame: Up to 2 years, except inter-reader agreement at baseline\\]\n\nNeed:\n\nCurrent treatment response evaluation relies on PSA changes and conventional imaging, which lack sensitivity and accuracy for early assessment. PSMA PET has demonstrated superior sensitivity for detecting prostate cancer lesions, but its role in longitudinal therapy monitoring remains undefined, with no specific regulatory approval for this indication. Prospective data on serial PSMA PET to guide treatment decisions in patients with clinically significant prostate cancer (Gleason score ≥7) are urgently needed.\n\nInclusion Criteria:\n\n1. Newly diagnosed, histologically confirmed clinically significant prostate cancer with Gleason score ≥7.\n2. Planned curative-intent or systemic therapy.\n3. Baseline PSMA PET performed prior to any treatment.\n4. Age ≥18 years.\n5. Written informed consent.\n\nExclusion Criteria:\n\n1. Prior prostate cancer treatment before baseline PSMA PET.\n2. Contraindication to PSMA PET imaging.\n3. Other active malignancy within past two years (excluding non-melanoma skin cancer).\n4. Unable to comply with follow-up schedule.",[27,123,124,125],"PSMA PET","Treatment Response","Therapy Monitoring",[26,123,124,125,127],"High-Risk","2026-04-20",{"date":130,"type":37},"2026-04-28",{"date":132,"type":37},"2021-03-07",{"date":134,"type":20},"2028-12-31",{"name":136,"class":44},"Xijing Hospital",9,{"id":139,"slug":140,"hasResults":11,"nctId":141,"briefTitle":142,"officialTitle":143,"acronym":144,"eligibilityCriteria":145,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":146,"targetDuration":4,"studyType":21,"phases":148,"briefSummary":150,"conditions":151,"keywords":155,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":157,"lastUpdatePostDateStruct":158,"startDateStruct":160,"completionDateStruct":162,"leadSponsor":164,"locationsCount":45},"100597119","phase-1-comparison-of-177lu-psma-617-and-225ac-psma-617-100597119","NCT07054346","Comparison of 177Lu-PSMA-617 and 225Ac-PSMA-617","Comparison of 177Lu-PSMA-617 and 225Ac-PSMA-617 in a Prostatectomy Model (LUTACT Trial)","LUTACT","Inclusion Criteria:\n\n1. Histologically confirmed prostate adenocarcinoma.\n2. Willing to undergo prostatectomy with or without lymph node dissection, and candidate for prostatectomy as determined by urologic oncology.\n3. High-risk disease as defined as meeting 1 or more of the 3 following criteria:\n\n   1. Gleason score of 4+5 disease or higher.\n   2. Pelvic nodal metastases on PSMA PET.\n   3. Extracapsular extension or seminal vesicle invasion on MRI.\n4. No evidence of distant metastatic disease as determined by PSMA PET. Nodal disease below the iliac bifurcation (clinical stage N1) is allowed.\n5. Maximum Standardized Uptake Value (SUVmax) in the primary tumor greater than 10 on PSMA PET using Gallium-68 (68Ga)-PSMA-11 or piflufolastat F 18 (18F-DCFPyL).\n6. Target tumor in the prostate measuring greater than 1.5 cm on MRI.\n7. Age ≥18 years.\n8. Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2 (Karnofsky ≥ 60%),\n9. Demonstrates adequate organ function as defined below:\n\n   1. Platelets ≥100,000\u002FmcL, independent of transfusions or growth factors within 3 months of treatment start.\n   2. Hemoglobin ≥10 g\u002FdL, independent of transfusions or growth factors within 3 months of treatment start.\n   3. Absolute Neutrophil Count (ANC) ≥1,500\u002Fmicroliter (mcL).\n   4. Creatinine clearance Glomerular filtration rate (GFR) ≥ 60 mL\u002Fmin\u002F1.73 m\\^2 , calculated using the Cockcroft-Gault equation.\n   5. Albumin ≥2.5 g\u002FdL.\n   6. Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) ≤3.0 x ULN.\n   7. Total bilirubin (TBIL) ≤2 x the institutional upper limit of normal (ULN). For participants with known Gilbert's Syndrome ≤3 x ULN is permitted.\n10. Ability to understand and the willingness to sign a written informed consent document.\n11. Participants must provide consent to comply to recommended radioprotection precautions during study.\n12. Participants must use adequate contraception and not donate sperm while on study drug and for at least 14 weeks after the last study treatment.\n\nExclusion Criteria:\n\n1. Has received prior prostate cancer therapy.\n\n   a. Prior 5-alpha reductase inhibitors (e.g. finasteride, dutasteride) allowed if discontinued at least 3 weeks prior to treatment start.\n2. Has participated in a study of an investigational therapeutic product and received study treatment or used an investigational device within four weeks of the first dose of treatment.\n3. Dry mouth that impacts the eating of food (i. e. requiring mouthwash prior to eating).\n4. Concurrent serious (as determined by the principal investigator) medical conditions including but not limited to New York Heart Association class III or IV congestive heart failure, history of congenital prolonged QT syndrome, uncontrolled infection, known active hepatitis B or C or other significant co-morbid conditions that in the opinion of the investigator would impair study participation or cooperation.\n5. Diagnosed with other malignancies that are expected to alter life expectancy or may interfere with disease assessment. However, participants with a prior history of malignancy that has been adequately treated and who have been disease free, treatment free for more than 3 years prior to randomization, or participants with adequately treated non-melanoma skin cancer, superficial bladder cancer are eligible.\n6. Individuals with a prior or concurrent malignancy whose natural history or treatment has the potential to interfere with the safety or efficacy assessment of the investigational regimen.\n7. Prior external beam radiation therapy (EBRT) to the prostate or prostate bed.\n\nAdditional exclusion criteria applicable only to participants undergoing intraarterial administration of PSMA RLT:\n\n1. Severe allergy to iodinated contrast.\n2. Severe atherosclerosis from prior CT imaging study, or greater than 10 pack-year smoking history if no prior imaging available.",{"count":147,"type":20},45,[149],"PHASE1","There is evidence that Actinium-225 Prostate-Specific Membrane Antigen (225Ac-PSMA) has a potentially higher level of efficacy than 177 Lutetium Prostate-Specific Membrane Antigen (177Lu-PSMA) as a radioligand therapy. This single center, pilot study will compare differences in the mechanisms of actinium-225 and lutetium-177 radioligand therapies (RLT) in participants with high or very high risk localized or locoregional prostate cancer planning on undergoing a prostatectomy.",[26,152,27,153,154],"Prostate Cancer (Diagnosis)","Localized Prostate Carcinoma","Very High Risk Prostate Carcinoma",[156],"Radioligand Therapy","2026-03-26",{"date":159,"type":37},"2026-04-01",{"date":161,"type":37},"2025-07-08",{"date":163,"type":20},"2028-04-30",{"name":165,"class":44},"Thomas Hope",{"id":167,"slug":168,"hasResults":11,"nctId":169,"briefTitle":170,"officialTitle":171,"acronym":172,"eligibilityCriteria":173,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":174,"targetDuration":4,"studyType":21,"phases":176,"briefSummary":177,"conditions":178,"keywords":180,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":188,"lastUpdatePostDateStruct":189,"startDateStruct":191,"completionDateStruct":193,"leadSponsor":195,"locationsCount":198},"100484856","phase-2-a-single-arm-phase-ii-study-of-neoadjuvant-intensified-androgen-deprivation-leuprolide-and-abiraterone-acetate-in-combination-with-akt-inhibition-capivasertib-for-high-risk-localized-prostate-cancer-with-pten-loss-100484856","NCT05593497","A Single-Arm Phase II Study of Neoadjuvant Intensified Androgen Deprivation (Leuprolide and Abiraterone Acetate) in Combination With AKT Inhibition (Capivasertib) for High-Risk Localized Prostate Cancer With PTEN Loss","Precision Neoadjuvant Therapy for High Risk Localized Prostate Cancer With PTEN Loss","SNARE","Inclusion Criteria:\n\n1. Informed Consent: provision of signed informed consent, which includes compliance with the requirements and restrictions listed in the informed consent form (ICF) and in this protocol.\n2. Age greater than or equal to 18 years. Members of all races and ethnic groups will be included.\n3. Participants must have histologically confirmed non-metastatic adenocarcinoma of the prostate\n4. (a) Any one of the following three high risk features:\n\n   * Gleason sum \\>7 (ISUP Grade Group \\>3)\n   * Clinical stage T3 (resectable), per AJCC Cancer Staging Manual, 8th ed.\n   * PSA \\> 20 ng\u002Fml oSubjects who meet high risk criteria solely by PSA (i.e., stage \\\u003CT3 AND Gleason sum less than or equal to 7) must have a progression-free probability after radical prostatectomy that is less than or equal to 50% at 5 years as estimated by the Memorial Sloan Kettering (MSK) pre-radical prostatectomy nomogram: https:\u002F\u002Fwww.mskcc.org\u002Fnomograms\u002Fprostate\u002Fpre\\_op (b) Subjects not meeting high risk criteria that have the following combination may be screened for inclusion:\n   * Gleason score 4+3=7 (ISUP Grade Group 3) AND\n   * Estimated progression-free probability after radical prostatectomy that is less than or equal to 50% at 5 years by MSK nomogram\n5. No definitive evidence of metastasis on nuclear bone scan (required on all subjects)\n6. No evidence of lymph nodes \\> 2 cm in diameter on pelvic CT scan (scan only required in patients with a PSA \\> 20 ng\u002Fml)\n7. Prostatectomy with extended lymph node dissection planned as primary therapy.\n\n   * The subject had a discussion with a clinician about other options, such as radiotherapy, and elected to undergo surgical treatment.\n   * The subject has been offered consultation with radiation oncology and declined consultation or radiation treatment, or determined it was not in best medical interest\n8. Be willing to provide tissue from a diagnostic biopsy core or excisional biopsy of a tumor lesion obtained up to 6 months\u002F180 days prior to initiation of treatment on Day 1. Subjects for whom samples cannot be provided (e.g., inaccessible or subject safety concern) may submit an older archived specimen only upon agreement from the Sponsor-Investigator.\n9. Tumor tissue must be provided for biomarker analysis. PTEN IHC staining must be less than or equal to 10% as determined by the central lab. If insufficient tumor tissue content is provided for analysis, acquisition of additional archived tumor tissue (block and \u002For slides) for the biomarker analysis is required.\n10. Have a performance status of 0 or 1 on the ECOG Performance Scale with no deterioration over the previous 2 weeks prior to baseline or day of first dosing.\n11. Life expectancy of greater than 10 years per the treating physician.\n12. Minimum body weight of 45 kg with minimum Body Mass Index (BMI) of 18.5\n13. Non-sterile men who are not totally sexually abstinent (i.e., refraining from heterosexual intercourse during the entire period of risk associated with study interventions) and intend to be sexually active with a women of childbearing potential partner must use a condom upon entering the study and until 16 weeks after the last dose of capivasertib. Contraception should be considered in females' partners of men taking capivasertib who are of childbearing potential\n14. Able and willing to swallow and retain oral medication\n15. Demonstrate adequate organ function as defined by laboratory parameters including ANC, platelets, hemoglobin, transaminases, albumin, hemoglobin A1C, CrCl or eGFR, PTT and INR (unless anticoagulated, then therapeutic range is acceptable). All screening labs should be performed within 30 days of treatment initiation\n\nExclusion Criteria:\n\n1. As judged by the investigator, any evidence of diseases (such as severe or uncontrolled systemic diseases, including uncontrolled hypertension, renal transplant and active bleeding diseases, uncontrolled pulmonary, renal, or hepatic dysfunction, uncontrolled infection, cardiac disease) which, in the investigator's opinion, makes it undesirable for the participant to participate in the study or that would jeopardize compliance with the protocol.\n2. Any other disease, physical examination finding, or clinical laboratory finding that, in the investigator's opinion, gives reasonable suspicion of a disease or condition that contraindicates the use of an investigational drug, may affect the interpretation of the results, render the patient at high risk from treatment complications or interferes with obtaining informed consent.\n3. Known to have active hepatitis infection, positive hepatitis C antibody, hepatitis B virus surface antigen or hepatitis B virus core antibody, at screening. Known to have human immunodeficiency virus (HIV) with a CD4+ T-cell count \\\u003C 350 cells\u002FuL or a history of an acquired immunodeficiency syndrome (AIDS)-defining opportunistic infection within the past 12 months. Known to have active tuberculosis infection (clinical evaluation that may include clinical history, physical examination and radiographic findings, or tuberculosis testing in line with local practice).\n\n   Known history of drug or alcohol abuse within 6 months of screening.\n4. Prior prostate cancer treatment including:\n\n   * Anti-androgen therapy including orchiectomy, LHRH therapy, abiraterone, ketoconazole, estrogen therapy (Short-term ADT allowed, less than or equal to 2 months)\n   * Radiation (external beam or brachytherapy)\n   * Cytotoxic chemotherapy\n   * Focal or ablative therapy\n   * Any experimental therapy for treatment of prostate cancer.\n5. History of another primary malignancy except for malignancy treated with curative intent with no known active disease greater than or equal to 5 years before the first dose of study intervention and of low potential risk for recurrence. Exceptions include basal cell carcinoma of the skin and squamous cell carcinoma of the skin that has undergone potentially curative therapy\n6. Any of the following cardiac criteria:\n\n   * Mean resting corrected QT interval (QTc) \\> 470 msec obtained from 3 consecutive ECGs\n   * Any clinically important abnormalities in rhythm, conduction or morphology of resting ECG (e.g., complete left bundle branch block, third-degree heart block)\n   * Medical history significant for arrhythmia (e.g., multifocal premature ventricular contractions, bigeminy, trigeminy, ventricular tachycardia), which is symptomatic or requires treatment (CTCAE Grade 3), symptomatic or uncontrolled atrial fibrillation despite treatment, or asymptomatic sustained ventricular tachycardia. Participants with atrial fibrillation controlled by medication or arrhythmias controlled by pacemakers may be permitted to enter the study\n   * Any factors that increase the risk of QTc prolongation or risk of arrhythmic events such as heart failure, hypokalemia, potential for torsades de pointes, congenital long QT syndrome, family history of long QT syndrome or unexplained sudden death under 40 years of age, or any concomitant medication known to prolong the QT interval\n   * Clinically significant heart disease as evidenced by myocardial infarction, or arterial thrombotic events in the past 6 months, severe or unstable angina, or NYHA or Class II to IV heart failure or cardiac ejection fraction measurement of \\\u003C 50%\n   * Experience of any of the following procedures or conditions in the preceding 6 months: coronary artery bypass graft, angioplasty, vascular stent, myocardial infarction, angina pectoris, congestive heart failure NYHA Grade less than or equal to 2\n   * Uncontrolled hypotension - systolic blood pressure (SBP) \\\u003C90 mmHg and\u002For diastolic blood pressure (DBP) \\\u003C50 mmHg\n   * Uncontrolled hypertension (SBP greater than or equal to 160 mmHg or DBP greater than or equal to 95 mmHg).\n   * Cardiac ejection fraction outside institutional range of normal or \\\u003C50% (whichever is higher) as measured by echocardiogram (or multiple-gated acquisition \\[MUGA\\] scan if an echocardiogram cannot be performed or is inconclusive).\n7. Clinically significant abnormalities of glucose metabolism as defined by any of the following:\n\n   * Patients with diabetes mellitus type 1 or diabetes mellitus type 2 requiring insulin treatment\n   * HbA1c greater than or equal to 8.0% (63.9 mmol\u002Fmol)\n8. Refractory nausea and vomiting, chronic gastrointestinal disease, inability to swallow the formulated product, or previous significant bowel resection that would preclude adequate absorption, distribution, metabolism, or excretion of capivasertib and abiraterone.\n9. Has known psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the trial.\n10. Previous allogeneic bone marrow transplant or solid organ transplant\n11. Received major surgery within 6 weeks prior to screening, or significant traumatic injury within 4 weeks of the first dose of study intervention or an anticipated need for major surgery during the study except for prostatectomy; they must have recovered adequately from the toxicity and\u002For complications from the intervention prior to starting therapy.\n12. Is currently participating and receiving study therapy, or has participated in a study of an investigational agent or study drugs within 30 days or 5 half-lives (whichever is longer) of the first dose of study treatment\n13. Has had a prior anti-cancer monoclonal antibody (mAb) within 30 days prior to study Day 1 or who has not recovered (i.e., less than or equal to Grade 1 or at baseline) from adverse events due to agents administered more than 30 days earlier.\n14. Has had prior chemotherapy, immunotherapy, targeted small molecule therapy, immunosuppressant medication (other than corticosteroids), or radiation therapy within 30 days prior to study Day 1, or who has not recovered (i.e., less than or equal to Grade 1 or at baseline) from adverse events due to a previously administered agent.\n\n    Note: Subjects with less than or equal to Grade 2 neuropathy are an exception to this criterion and may qualify for the study if ECOG 0-1.\n\n    Note: A longer washout may be required for drugs with a long half-life (e.g., 30 days or 5 half-lives, whichever is longer)\n15. Treatment with any of the following:\n\n    * Nitrosourea or mitomycin C within 6 weeks of the first dose of study treatment\n    * Potent inhibitors or inducers of CYP3A4 within 2 weeks before the start of study treatment (3 weeks for St John's wort), or sensitive substrates of CYP3A4, CYP2C9 and\u002For CYP2D6 with a narrow therapeutic window within 1 week before the start of study treatment\n    * Drugs known to prolong the QT interval within 5 half-lives of the first dose of study treatment\n    * Any concomitant medication that may interfere with abiraterone safety and efficacy based on the prescribing information of abiraterone and local clinical guidelines\n16. History of hypersensitivity to active or inactive excipients of capivasertib, abiraterone, or drugs with a similar chemical structure or class.\n17. Any restriction or contraindication based on the local prescribing information that would prohibit the use of abiraterone and leuprolide.\n18. Is unable to undergo research related biopsy as this is necessary to complete translational study objectives.\n19. Judgment by the investigator that the participant should not participate in the study if the participant is unlikely to comply with study procedures, restrictions and requirements.",{"count":175,"type":20},30,[23],"The purpose of this study is to learn about how an investigational drug intervention completed before doing prostate surgery (specifically, radical prostatectomy with lymph node dissection) may help in treatment of high risk localized prostate cancers that are most resistant to standard treatments. This is a phase II research study. For this study, capivasertib, the study drug, will be taken with intensified androgen deprivation drugs (iADT; abiraterone and leuprolide) prior to radical prostatectomy. This study drug treatment will be evaluated to see if it is effective in shrinking and destroying prostate cancer tumors prior to surgery and to further evaluate its safety prior to prostate cancer surgery.",[179],"High-Risk Prostate Cancer",[181,99,182,183,184,185,186,187],"veterans","PTEN protein","prostatectomy","neoadjuvant therapy","abiraterone acetate","capivasertib","leuprolide","2026-03-23",{"date":190,"type":37},"2026-03-27",{"date":192,"type":37},"2024-05-31",{"date":194,"type":20},"2027-08-01",{"name":196,"class":197},"VA Office of Research and Development","FED",6,{"id":200,"slug":201,"hasResults":11,"nctId":202,"briefTitle":203,"officialTitle":204,"acronym":4,"eligibilityCriteria":205,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":206,"targetDuration":4,"studyType":21,"phases":208,"briefSummary":210,"conditions":211,"keywords":212,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":216,"lastUpdatePostDateStruct":217,"startDateStruct":219,"completionDateStruct":221,"leadSponsor":223,"locationsCount":45},"100584343","early-phase-1-a-platform-study-of-epigenetic-therapy-before-prostatectomy-in-men-with-prostate-cancer-100584343","NCT06888102","A Platform Study of Epigenetic Therapy Before Prostatectomy in Men With Prostate Cancer","IIT2023-10-Posadas-PC-Net : A Platform Study of Epigenetic Therapy Before Prostatectomy in Men With Prostate Cancer","Inclusion Criteria\n\n* Men electing to undergo radical prostatectomy with preoperative tissue available.\n* Age ≥18 years\n* Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 0 or 1\n* Adequate organ function defined by:\n\n  * AST and ALT \\\u003C 2.5 x ULN\n  * Total bilirubin \\\u003C 1.5 x ULN\n  * Platelets \\> 90 x 1000\u002FμL\n  * Hemoglobin (Hgb) \\> 8.5 g\u002FdL\n  * Serum Creatinine (Cr) \\\u003C1.5 x ULN or eGFR \\> 30 mL\u002Fmin\n* People with partners of childbearing potential in circumstances that may result in the pregnancy, must have had a successful vasectomy (with medically confirmed lack of sperm that are alive) OR must either practice complete abstinence or agree to use adequate contraception (latex or synthetic condom during sexual contact with a female of childbearing potential) from the start of study treatment until 3 months following last dose of study intervention. Subjects should not donate sperm on study, during interruptions in treatment and for 3 months following completion of study drug treatment.\n* Written informed consent obtained from subject and ability for subject to comply with the requirements of the study.\n\nExclusion Criteria\n\n* Active intercurrent illness or malignancy requiring therapy outside of prostate cancer.\n* Other anti-cancer therapy (chemotherapy, hormonal therapy, radiation therapy, surgery, immunotherapy, biologic therapy, or tumor embolization)\n* Currently participating in a study using an investigational, medicinal anti-cancer agent within 4 weeks prior to first dose of epigenetic therapy.",{"count":207,"type":20},20,[209],"EARLY_PHASE1","This is an open-label, non-randomized, exploratory platform protocol designed to assess the safety and antitumor activity of epigenetic therapies in participants with localized prostate cancer who are undergoing radical prostatectomy. The epigenetic therapy is intended to increase the sensitivity of the underlying tumor to the patient's immune system. The platform study will evaluate safety, biomarkers, and clinical activity of an epigenetic therapy. The particular details relevant to each module within this platform study will be provided as appendices to the core protocol.",[27],[213,214,215],"Epigenetic Therapy","PD-L1","radical prostatectomy","2026-02-02",{"date":218,"type":37},"2026-02-03",{"date":220,"type":20},"2026-04",{"date":222,"type":20},"2029-10",{"name":224,"class":44},"Edwin Posadas, MD",{"id":226,"slug":227,"hasResults":11,"nctId":228,"briefTitle":229,"officialTitle":229,"acronym":230,"eligibilityCriteria":231,"healthyVolunteers":11,"sex":16,"minAge":232,"maxAge":4,"enrollmentInfo":233,"targetDuration":4,"studyType":21,"phases":235,"briefSummary":236,"conditions":237,"keywords":238,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":243,"lastUpdatePostDateStruct":244,"startDateStruct":246,"completionDateStruct":248,"leadSponsor":250,"locationsCount":45},"100620410","delayed-pelvic-imaging-with-68ga-psma-petct-in-a-patient-with-high-risk-prostate-cancer-100620410","NCT07357259","Delayed Pelvic Imaging With [68]Ga-PSMA PET\u002FCT in a Patient With High-risk Prostate Cancer.","SPIR202302","Inclusion Criteria:\n\n* Newly diagnosed prostate cancer undergoing staging, or\n* Biochemical recurrence following prior radical-intent therapy (surgery and\u002For radiotherapy), or\n* High-risk prostate cancer, defined as Gleason Score ≥ 8 or PSA ≥ 20 ng\u002FmL.\n* Written informed consent and authorization for personal data processing.\n\nExclusion Criteria:\n\n* Genitourinary comorbidities that could interfere with imaging or interpretation.\n* Intermediate- or low-risk prostate cancer.\n* Delayed acquisition performed on a PET\u002FCT scanner different from the standard acquisition.\n* Additional PET\u002FCT required due to artifacts compromising diagnostic quality (e.g., urinary retention, excessive motion).\n* Patients previously enrolled who require repeat PET\u002FCT as a new visit.\n* Inability to provide informed consent or impaired decision-making capacity.\n* Known hypersensitivity to the radiopharmaceutical or its components.\n* Contraindications to PET\u002FCT (e.g., severe claustrophobia, morbid obesity, inability to cooperate).","30 Years",{"count":234,"type":20},244,[93],"Recent evidence suggests that both standard-time and delayed-time \\[⁶⁸Ga\\]Ga-PSMA PET acquisitions can reveal clinically relevant findings, and neither phase should be excluded a priori in routine practice. This study evaluates a streamlined dual-phase protocol consisting of:\n\n* A standard whole-body PET\u002FCT acquisition performed 60 minutes after radiotracer administration.\n* A delayed pelvic PET-only acquisition performed 90 minutes post-injection, reconstructed using the attenuation-correction CT (CT\u002FAC) obtained from the initial whole-body scan.\n\nBecause the prostate gland and pelvic lymph nodes exhibit minimal physiological mobility, accurate PET-CT anatomical correspondence can be maintained through careful patient repositioning, without repeating the CT scan.\n\nThe main advantage of this protocol is a reduction in patient radiation exposure, as the delayed phase does not require a second CT scan. It also reduces in-department time and maintains diagnostic quality of PET interpretation, provided that the PET-CT alignment remains acceptable.\n\nThis method may additionally enhance workflow efficiency in the Nuclear Medicine Unit by allowing early identification-based on predefined clinical parameters-of patients most likely to benefit from delayed pelvic imaging.",[27],[239,240,241,242],"PET\u002FCT","[68]Ga - PSMA","Delay CT scan","Radiation Dose Optimization","2026-01-12",{"date":245,"type":37},"2026-01-21",{"date":247,"type":37},"2025-02-03",{"date":249,"type":20},"2027-03-01",{"name":251,"class":44},"IRCCS Azienda Ospedaliero-Universitaria di Bologna",{"id":253,"slug":254,"hasResults":11,"nctId":255,"briefTitle":256,"officialTitle":257,"acronym":4,"eligibilityCriteria":258,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":259,"targetDuration":4,"studyType":21,"phases":260,"briefSummary":261,"conditions":262,"keywords":263,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":269,"lastUpdatePostDateStruct":270,"startDateStruct":272,"completionDateStruct":274,"leadSponsor":276,"locationsCount":45},"100608952","phase-1-tb-psma-it-radionuclide-before-radical-prostatectomy-in-patients-with-locally-advanced-prostate-cancer---tbeforeprost-trial-100608952","NCT07208240","Tb-PSMA-I&T Radionuclide Before Radical Prostatectomy in Patients With Locally Advanced Prostate Cancer - TbeforePROST Trial.","Tb-PSMA-I&T Radionuclide Neo-Adjuvant Treatment in Patients With Locally Advanced Prostate Cancer Before Radical Prostatectomy: TbeforePROST Trial.","Inclusion Criteria:\n\n* Male aged 18 years and older.\n* Patients with high-risk localized prostate cancer (cT3\u002F4 and\u002For Gleason score ≥ eight and\u002For prostate biopsy or PSA ≥ 20 ng\u002Fdl)\n* High PSMA expression was confirmed according to PROMISE V2 8\n* Patients should have an Eastern Cooperative Oncology Group (ECOG) performance status score of 1 or lower and a life expectancy of \\> 10 years.\n\nExclusion Criteria:\n\n* Platelet count lower than 150×103\u002Fµl\n* white blood cell count lower than 4×103\u002Fµl,\n* haemoglobin concentration lower than 12mg\u002Fdl.\n* albumin concentration lower than 3.5 g\u002Fdl.\n* glomerular filtration rate (GFR) lower than 40 mL\u002Fmin.\n* usage of nephrotoxic drugs\n* distant metastatic disease",{"count":207,"type":20},[149,23],"This is a multi-disciplinary collaboration between urologists, oncologists and nuclear medicine physicians from Beilinson hospital at Rabin Medical Center to address the major therapeutic challenge of locally advanced prostate cancer. Our aim is to evaluate the use of a novel treatment (Tb-PSMA) prior to the surgical removal of the prostate. This treatment has already shown initial promising results in patients with metastatic prostate cancer but has never been tested for locally advanced disease before surgery.",[60],[264,265,266,267,268],"High risk Prostate cancer","Radical Prostatectomy","PSMA","Theranostics","radionuclide therapy","2025-09-26",{"date":271,"type":37},"2025-10-06",{"date":273,"type":37},"2025-08-12",{"date":275,"type":20},"2028-08-12",{"name":277,"class":44},"Rabin Medical Center",{"id":279,"slug":280,"hasResults":11,"nctId":281,"briefTitle":282,"officialTitle":282,"acronym":283,"eligibilityCriteria":284,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":285,"targetDuration":4,"studyType":120,"phases":4,"briefSummary":287,"conditions":288,"keywords":4,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":289,"lastUpdatePostDateStruct":290,"startDateStruct":292,"completionDateStruct":294,"leadSponsor":296,"locationsCount":298},"100589041","prospective-observational-study-of-stereotactic-body-radiation-therapy-with-androgen-deprivation-therapy-for-organ-confined-high-risk-prostate-cancer-the-prostar-trial-100589041","NCT06949254","PRospective Observational Study of STereotactic Body rAdiation Therapy With Androgen Deprivation Therapy for Organ-confined High-risk Prostate Cancer: the PROSTAR Trial","PROSTAR","Inclusion Criteria:\n\n* Age \\> 18 years\n* ECOG performance status ≤ 2\n* Histologically proven prostate adenocarcinoma\n* High-risk group classification according to National Comprehensive Cancer Network (NCCN), defined by the presence of any one of the following high-risk factors: cT3-cT4 OR Grade Group 4 or Grade Group 5 OR PSA \\>20 ng\u002FmL\n* No pelvic nodal and distant metastases at staging with PSMA-PET\n* IPSS ≤ 15 (alpha blockers allowed)\n* Life expectancy of \\> 5 years\n* Prostate volume ≤ 100 cc\n\nExclusion Criteria:\n\n* Previous local radiation treatment of the prostate\n* Previous radiotherapy to the pelvis\n* Active Ulcerative Colitis or Crohn's Disease\n* Previous tumors unless disease free for a minimum of 5 years",{"count":286,"type":20},49,"Prostate Cancer (PCa) is the second most common malignancy and the 5th common cause of cancer-related mortality in men worldwide. The majority of patients with PCa is diagnosed with potentially curable disease and its management includes different approaches, such as surgery, Radiation Therapy (RT) and Androgen Deprivation Therapy (ADT), for exclusive use or in combination each other. Randomized clinical trials have shown that moderate hypofractionated RT (i.e., 2.5-4 Gy per fraction) has become a valid alternative to conventionally fractionated RT in patients with PCa. The rationale of hypofractionation is based on the strong radiobiological evidence of the low α\u002Fβ ratio of PCa cells (1.5-2 Gy) and the greater sensitivity to high dose per fraction. Data suggests that prostate Stereotactic Body Radiation Therapy (SBRT) is an alternative treatment strategy for localized PCa with promising results in terms of disease control and toxicity, not inferior to conventionally fractionated RT. A systematic review of over 6000 men underwent prostate SBRT on prospective studies has demonstrated that this treatment provides favorable patient's quality of life, excellent disease control, and results in minimal serious acute or late toxicity.\n\nAlmost all the published studies, investigated the role of SBRT for organ-confined low- and intermediate favorable-risk disease. However, the HYPO-RT-PC trial addressed the role of SBRT in the context of unfavorable localized PCa. In this non-inferiority, phase III multicenter trial 1200 patients with either intermediate or high risk PCa were enrolled. The aim of the study was to demonstrate that SBRT (42.7 Gy in 7 fractions, 3 days per week, for 2.5 weeks) is non-inferior to conventional fractionation (78 Gy in 39 fractions, 5 days per week for 8 weeks) regarding failure-free survival, without significant differences in late normal tissues complications. Failure-free survival at 5 years was 84% in both treatment arms; adjusted HR was 1.002, hence ultra-hypofractionation was found to be non-inferior to conventional fractionated RT (given HR limit = 1.338). These results paved the way for the use of SBRT even in patients with unfavorable PCa. One controversial issue is the role of ADT in the setting of SBRT for localized PCa: in conventionally fractionated schedules, short term (4-6 months) and long term (1.5-3 years) ADT are considered the standard of care for unfavorable intermediate and high-risk PCa, respectively. However, in a systematic review\u002Fmeta-analysis no benefit was found for ADT added to SBRT and similar results were reported also by King et al. in a retrospective study on over 1000 patients. The PACE C trial is one of three cohort of PACE that is multicenter, international phase 3 randomized controlled study. PACE C is set to explore the efficacy of SBRT in combination with ADT for patients with unfavorable intermediate and high-risk PCa and will recruit 1182 patients who will be randomized to receive either hypofractionated RT (60 Gy in 20 fractions) or SBRT delivered with 36.25 Gy in 5 fractions.\n\nIn this scenario, our study aims to evaluate the safety and efficacy of SBRT (40 Gy in 5 fractions every other day) coupled with ADT (relugolix 18-24 monthsaccording to clinical care) in patients with localized high-risk PCa.",[60],"2025-07-29",{"date":291,"type":37},"2025-07-30",{"date":293,"type":37},"2025-04-04",{"date":295,"type":20},"2032-05",{"name":297,"class":44},"Istituto Clinico Humanitas",3,{"id":300,"slug":301,"hasResults":11,"nctId":302,"briefTitle":303,"officialTitle":303,"acronym":304,"eligibilityCriteria":305,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":306,"enrollmentInfo":307,"targetDuration":4,"studyType":21,"phases":309,"briefSummary":310,"conditions":311,"keywords":312,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":317,"lastUpdatePostDateStruct":318,"startDateStruct":320,"completionDateStruct":322,"leadSponsor":324,"locationsCount":45},"100574407","phase-2-surgical-treatment-with-or-without-apalutamide-in-subjects-with-high-risk-prostate-cancer-who-are-candidates-for-radical-prostatectomy-and-staged-as-oligometastatic-with-psma-pet-100574407","NCT06758882","Surgical Treatment With or Without Apalutamide in Subjects With High Risk Prostate Cancer Who Are Candidates for Radical Prostatectomy and Staged as Oligometastatic With PSMA-PET","STAPLE","Inclusion Criteria:\n\n1. ≥ 18 years of age, \\\u003C 80 years of age\n2. Signed informed consent form (ICF) indicating that the subject understands the purpose and procedures required for the study and is willing to participate in the study; subjects must be willing and able to adhere to the prohibitions and restrictions specified in this protocol (Section 4.3)\n3. Histologically confirmed adenocarcinoma of the prostate\n4. High-risk disease defined by a total Gleason Sum Score ≥ 4+4 (=Grade Groups \\[GG\\] 4-5)\n5. Conventional imaging negative for metastases\n6. Presence of low volume metastatic disease at pre-surgery PSMA PET\u002FCT. The metastatic burden is classified according to the definition used in the CHARTEED trial applied to PSMA PET\u002FCT, where high metastatic burden was defined as four or more bone metastases with one or more outside the vertebral bodies or pelvis, or visceral metastases, or both; all other assessable patients were considered to have low metastatic burden\n7. Candidate to RP with PLND\n8. Eastern Cooperative Oncology Group (ECOG) Performance Status score of 0 or 1\n9. Adequate organ function determined by the following laboratory values:\n\n   1. Aspartate aminotransferase (AST), alanine aminotransferase (ALT) and total bilirubin within normal limits, ie, ≤ the upper limit of normal \\[ULN\\] (note that in subjects with Gilbert's syndrome, if total bilirubin is \\>1.5 X ULN, measure direct and indirect bilirubin. If direct bilirubin is ≤1.5 X ULN, the subject may be eligible);\n   2. Serum creatinine \\\u003C1.8 mg\u002FdL;\n   3. Platelets ≥75.000\u002FdL, without transfusion and\u002For growth factors within 56 days prior to RP;\n   4. Haemoglobin ≥11.0 g\u002FdL, without transfusion and\u002For growth factors within 56 days prior to RP;\n10. Able to receive ADT for at least 18 months, based on cardiovascular risk assessment and the investigator's assessment\n11. Be able to swallow whole study drug tablets\n\nExclusion Criteria:\n\n1. Distant metastasis based on conventional imaging (CT scan or bone scintigraphy). Nodal disease below the iliac bifurcation (clinical stage N1 at CT scan) is not an exclusion criterion.\n2. Prior hormonal treatment (GnRHa, agonist or antagonist)\n3. Prior bilateral orchiectomy\n4. History of prior systemic or local therapy for prostate cancer, including pelvic radiation and whole gland or focal ablative modalities for prostate cancer\n5. Use of any investigational agent ≤4 weeks prior to RP or any therapeutic procedure for prostate cancer at any time\n6. Major surgery ≤4 weeks prior to RP\n7. Any of the following within 12 months prior to first dose of study drug: severe or unstable angina, myocardial infarction, symptomatic congestive heart failure, arterial or venous thromboembolic events (eg, pulmonary embolism, cerebrovascular accident including transient ischemic attacks), or clinically significant ventricular arrhythmias or New York Heart Association Class II to IV heart disease; uncomplicated deep vein thrombosis is not considered exclusionary\n8. Human immunodeficiency virus-positive subjects with 1 or more of the following: (1) not receiving highly active antiretroviral therapy; (2) had a change in antiretroviral therapy within 6 months of the start of screening; (3) receiving antiretroviral therapy that may interfere with study drug (consult Sponsor for review of medication prior to enrolment); (4) CD4 count \\\u003C350 at screening; (5) AIDS-defining opportunistic infection within 6 months of start of screening; (6) active or symptomatic viral hepatitis or chronic liver disease; ascites or bleeding disorders secondary to hepatic dysfunction\n9. History of seizure; any condition that may predispose to seizure (including, but not limited to prior stroke, transient ischemic attack or loss of consciousness ≤1 year prior to RP); presence of brain arteriovenous malformation; or intracranial masses such as schwannomas and meningiomas that are causing edema or mass effect\n10. Patients taking any prohibited medications (as reported in session 6.2 of the protocol, including medicinal products known to prolong the QT interval and\u002For drugs commonly known to cause torsade de pointes and\u002For drugs known to lower the seizure threshold within 4 weeks prior to RP) should not be included\n11. Gastrointestinal conditions affecting absorption\n12. Known or suspected contraindications or hypersensitivity to apalutamide, GnRHa or any of the components of the formulations\n13. Any condition for which, in the opinion of the investigator, participation would not be in the best interest of the subject\n14. Active malignancies (ie, progressing or requiring treatment or treatment change in the last 24 months) other than prostate cancer. The only allowed exceptions are: non-muscle invasive bladder cancer (NMIBC); skin cancer (non-melanoma or melanoma) treated within the last 24 months that is considered completely cured; breast cancer (adequately treated lobular carcinoma in situ or ductal carcinoma in situ, or history of localized breast cancer and receiving antihormonal agents and considered to have a very low risk of recurrence); malignancy that is considered cured with minimal risk of recurrence.","80 Years",{"count":308,"type":20},94,[23],"This is a phase 2, open-label, randomized study of adjuvant treatment in subjects with high-risk prostate cancer who are candidates for RP with PLND based on M0 status at conventional imaging, but staged as oligometastatic with PSMA PET\u002FCT (performed as routine practice, according to recent evidence on high-risk prostate cancer patients). Ninety-four subjects will receive apalutamide plus ADT or ADT alone after surgery. ADT is defined as medical castration (ie, gonadotropin-releasing hormone analogues \\[GnRHa, agonist or antagonist\\]). Subjects will be randomly assigned in a 1:1 ratio to receive apalutamide plus ADT or ADT alone.\n\nPatients randomized to receive ADT + apalutamide or ADT alone will begin their adjuvant treatment 4 weeks (28 to 32 days) after surgery. A first dosage of PSA and testosterone will be performed just before starting adjuvant therapy but not before 28 days from surgery. Subsequently, PSA and testosterone dosage and clinical visits will be performed after 3 months from surgery and every 3 months until completion of study. PSMA PET\u002FCT scan will be performed yearly, or in case of PSA progression. The Posttreatment Follow-up Phase will begin after 18 months of ADT and will last for 6 months, until study completion. Afterwards, patients will continue their follow-up according to the best clinical practice.",[60],[313,314,215,315,316],"oligometastatic at PSMA PET\u002FCT","apalutamide","pelvic lymph node dissection","androgen deprivation therapy (ADT)","2024-12-28",{"date":319,"type":37},"2025-01-06",{"date":321,"type":37},"2024-11-25",{"date":323,"type":20},"2026-06",{"name":325,"class":44},"Marco Oderda",{"id":327,"slug":328,"hasResults":11,"nctId":329,"briefTitle":330,"officialTitle":331,"acronym":4,"eligibilityCriteria":332,"healthyVolunteers":11,"sex":16,"minAge":4,"maxAge":4,"enrollmentInfo":333,"targetDuration":4,"studyType":21,"phases":335,"briefSummary":336,"conditions":337,"keywords":343,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":347,"lastUpdatePostDateStruct":348,"startDateStruct":350,"completionDateStruct":352,"leadSponsor":354,"locationsCount":298},"100565015","phase-2-fk-pc101-as-adjuvant-therapy-for-men-with-high-risk-prostate-cancer-100565015","NCT06636682","FK-PC101 as Adjuvant Therapy for Men With High-Risk Prostate Cancer","A Multicenter, Adaptive, Phase 2, Randomized, Open-label Study of Irradiated Autologous Cellular Vaccine in Men With High-Risk Prostate Cancer Following Prostatectomy","Inclusion Criteria:\n\n* Has localized high-risk or very high-risk prostate cancer based on the NCCN v4.2023 classification.\n* Has ≥3 prostate biopsy cores with ≥50% tumor involvement.\n* Has PSA \\>4 ng\u002FmL ≤28 days prior to enrollment.\n* Has no evidence of distant metastases based on PSMA-PET\u002FCT performed ≤28 days prior to enrollment.\n* Is a candidate for radical prostatectomy, and scheduled radical prostatectomy date must be 3 to 14 days after enrollment.\n* Has not received nor plans to receive neoadjuvant (preoperative) radiation therapy, androgen deprivation therapy (ADT), or any other anticancer therapy.\n* Has a life expectancy \\>5 years.\n\nAdditional key eligibility criteria immediately postoperative for inclusion in the randomized population include:\n\n* Stage \\>pT3a (tumor has extended outside of the prostate on one side).\n* Gleason score of 8, 9, or 10 (high\u002Fvery high) on prostatectomy specimen.\n* Subjects with pT3b or pT4 tumors with a Gleason sum 7 (4+3) are eligible.\n* Pelvic lymph node dissection (PLND) is required with either pN0 or pN1 nodal staging permitted.\n* Subjects must have negative surgical margins or microscopic-only positive surgical margins.\n\nFinal eligibility criteria at 2 months postoperative for randomization include:\n\n* FK-PC101 has been produced for the subject and meets all release specifications.\n* An undetectable PSA (\\\u003C0.04 ng\u002FmL) on the most recent test performed prior to randomization (Day -4 to -7).\n* No prior, current, or planned future postoperative or adjuvant XRT, hormonal therapy such as ADT, or any other anticancer therapy (future therapy should not be administered until evidence exists of prostate cancer disease recurrence \\[such as PSA recurrence\\]).\n* Adequate organ function based on CBC and chemistry studies within 2 weeks of Day 1 (Day -14 to -7). Specific laboratory requirements include:\n\n  * Absolute neutrophil count (ANC) \\>1000\u002FµL\n  * Platelet count \\>100,000\u002FµL.\n  * Hemoglobin \\>8.0 gm\u002FdL.\n  * Estimated glomerular filtration rate (eGFR) \\>60 mL\u002Fminute based on Cockcroft-Gault formula.\n  * Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) both \\\u003C2 × upper limit of normal (ULN).\n  * Albumin \\>3.0 gm\u002FdL.\n* Capable of giving signed informed consent, which includes compliance with the requirements and restrictions of the study.\n\nExclusion Criteria:\n\n* Has an additional active malignancy that may confound the assessment of the study endpoints. If the subject has a past cancer history (active malignancy within 2 years prior to study entry) with substantial potential for recurrence, this must be discussed with the Sponsor before study entry. Note: Subjects with the following concomitant neoplastic diagnoses are eligible: non-melanoma skin cancer and carcinomas in situ (including breast DCIS, transitional cell carcinoma\u002FNMIBC, anal carcinoma, and melanoma in situ).\n* Is eligible for and elects to receive adjuvant therapy following RP.\n* Has clinically significant cardiovascular disease (e.g., uncontrolled or any New York Heart Association \\[NYHA\\] Class 3 or 4 congestive heart failure, uncontrolled angina, history of myocardial infarction, unstable angina, pulmonary embolism or stroke within 6 months prior to study entry, uncontrolled hypertension, or clinically significant arrhythmias not controlled by medication).\n* Has uncontrolled, clinically significant pulmonary disease (e.g., chronic obstructive pulmonary disease, pulmonary hypertension) that in the opinion of the Investigator would put the subject at significant risk for pulmonary complications during the study.\n* Has known metastases, such as bone, visceral, or brain or leptomeningeal metastases.\n* Has an active autoimmune disease or Grade ≥3 pneumonitis that has required systemic treatment in the past 2 years (i.e., with use of disease-modifying agents, corticosteroids, or immunosuppressive drugs). Replacement therapy (e.g., thyroxine, insulin, or physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency) or treatment with drugs (e.g., neomercazol, carbamazole) that function to decrease the generation of thyroid hormone by a hyperfunctioning thyroid gland (e.g., in Graves' disease) is not considered a form of systemic treatment of an autoimmune disease.\n* Is currently receiving systemic steroid therapy at a prednisone equivalent dose of \\>10 mg daily for at least 1 week or other form of immunosuppressive therapy within 7 days prior to enrollment.\n* Has uncontrolled intercurrent illness including, but not limited to, uncontrolled infection, disseminated intravascular coagulation, or psychiatric illness\u002Fsocial situations that would limit compliance with study requirements.\n* Is at risk for disseminated BCG infection or has previously demonstrated an allergic response to BCG or its components.\n* Has known positive status for human immunodeficiency virus (HIV) or active or chronic Hepatitis (Hep) B or Hep C. Screening is not required.\n* Has any medical condition which in the opinion of the Investigator places the subject at an unacceptably high risk for toxicity.",{"count":334,"type":20},100,[23],"The goal of this clinical trial is to learn if the vaccine FK-PC101 works to delay or prevent the return of prostate cancer in men who have had surgery to remove their prostate cancer. It will also learn about the safety of FK-PC101. The main questions it aims to answer are:\n\nDoes FK-PC101 delay or prevent the return of prostate cancer following surgery? What medical problems do participants (subjects) have when taking FK-PC101?\n\nResearchers will compare FK-PC101 to current treatment practice to see if FK-PC101 works to prevent or delay the return of prostate cancer following surgery to remove the prostate cancer tumor.\n\nSubjects will:\n\nHave a sample of the prostate cancer tissue collected at the time of surgery to remove this tissue from the body. This tissue will then be used to create a personalized vaccine that is specific to your prostate cancer.\n\nIf randomly selected to receive the vaccine, subjects will receive the vaccine up to 7 times over a 6-month period.\n\nIn addition to the treatment visits for those randomized to receive FK-PC101, there will be up to 4 follow up visits to the clinic over a 22-month (nearly 2 year) period.\n\nFor subjects randomized to receive current treatment practice, they will be asked to attend up to 8 visits over 22 months to track if there is any detectable cancer. Should their prostate cancer return within a year following surgery, they will be eligible to receive FK-PC101, which already had been produced and thus no additional tumor tissue would need to be obtained.\n\nSubjects in both study arms will have regular blood tests and scans to test whether their prostate cancer has returned.",[338,339,340,341,26,342,27],"Prostate Cancer (Adenocarcinoma)","Prostate CA","Prostate Cancers","Prostate Cancer (Post Prostatectomy)","Prostate Cancer Patients Undergoing Radical Prostatectomy",[344,345,346,265],"Vaccine","Prostatectomy","Autologous","2024-10-17",{"date":349,"type":37},"2024-10-21",{"date":351,"type":37},"2024-10-14",{"date":353,"type":20},"2027-05-04",{"name":355,"class":356},"Cellvax Therapeutics Inc","INDUSTRY",{"id":358,"slug":359,"hasResults":11,"nctId":360,"briefTitle":361,"officialTitle":362,"acronym":4,"eligibilityCriteria":363,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":306,"enrollmentInfo":364,"targetDuration":4,"studyType":21,"phases":366,"briefSummary":367,"conditions":368,"keywords":4,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":372,"lastUpdatePostDateStruct":373,"startDateStruct":375,"completionDateStruct":377,"leadSponsor":379,"locationsCount":45},"100470525","phase-2-neoadjuvant-intense-endocrine-therapy-for-high-risk-and-locally-advanced-prostate-cancer-100470525","NCT05406999","Neoadjuvant Intense Endocrine Therapy for High Risk and Locally Advanced Prostate Cancer","A Prospective, Multi-arm, Multi-center Clinical Trial on Neoadjuvant Intense Endocrine Therapy for High Risk and Locally Advanced Prostate Cancer","Inclusion Criteria:\n\n1. All patients must have been histologically diagnosed of prostate cancer and must be eligible for radical prostatectomy.\n2. All patients must undergo thorough tumor staging and meet one of the following criteria: a) multi-parameter MRI or PSMA PET\u002FCT shows clinical staging of primary tumor ≥ T3; b) Gleason score of primary tumor ≥ 8; c)prostate specific antigen(PSA) ≥20 ng\u002Fml; d) Imaging evaluation shows regional lymph node metastases (N1).\n3. Eastern Cooperative Oncology Group (ECOG) physical condition score ≤ 1.\n4. Patients must have adequate hematologic function, hepatic function, renal function and cardiac function.\n5. Patients must participate voluntarily and sign an informed consent form(ICF), indicating that they understand the purpose and required procedures of the study, and are willing to participate in. Patients must bewilling to obey the prohibitions and restrictions specified in the research protocol.\n6. Fertile patients must be willing to use highly effective contraception during the study period and within 120 days of the last dose of treatment.\n\nExclusion Criteria:\n\n1. Patients with neuroendocrine, small cell, or sarcoma-like pathologic features are not eligible.\n2. Patients with low-risk or medium-risk, localized prostate cancer (the following conditions are met at the same time) are not eligible: a) multiparameter MRI or PSMA PET \u002F CT shows clinical staging of primary tumor \\\u003C T3; b) Gleason score of primary tumor \\\u003C 8; c) prostate specific antigen (PSA) \\\u003C20 ng\u002Fml.\n3. Patients with clinical or radiological evidence of extra-regional lymph node metastases or bone metastases or visceral metastases (any M1) are not eligible.\n4. Patients who have previously received androgen deprivation therapy (medical or surgical) or focal treatment, radiotherapy, chemotherapy for prostate cancer are not eligible.\n5. Patients with severe or uncontrolled concurrent infections are not eligible.\n6. Patients must not have New York Heart Association Class III or IV congestive heart failure at the time of screening. Patients must not have any thromboembolic event, unstable angina pectoris, myocardial infarction within 6 months prior to registration.\n7. Patients must not have uncontrolled severe hypertension, persistent uncontrolled diabetes, oxygen-dependent lung disease, chronic liver disease, or HIV infection.\n8. Patients must not have had other malignancies other than prostate cancer in the past 5 years, but cured basal cell or squamous cell skin cancers can be enrolled.\n9. Patients with mental illness, mental disability or inability to give informed consent are not eligible.",{"count":365,"type":20},900,[23],"This is a prospective, multicenter, multi-arm, non-randomized, open-label clinical trial to evaluate the efficacy and safety of neoadjuvant intense endocrine therapy for high-risk or locally advanced prostate cancer.",[369,60,370,371],"Neoadjuvant Therapy","Locally Advanced Prostate Cancer","Intense Endocrine Therapy","2022-08-12",{"date":374,"type":37},"2022-08-16",{"date":376,"type":37},"2020-02-01",{"date":378,"type":20},"2030-06-30",{"name":380,"class":44},"The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School"]