Active, not recruitingInterventional · Phase 2NCT03371719 ↗A Phase II, Double-Blinded, Placebo-Controlled Randomized Trial of Salvage Radiotherapy With or Without Enhanced Anti-Androgen Therapy With Apalutamide in Recurrent Prostate Cancer (BALANCE*)
RecruitingInterventional · Phase 3NCT03678025 ↗Phase III Randomized Trial of Standard Systemic Therapy (SST) Versus Standard Systemic Therapy Plus Definitive Treatment (Surgery or Radiation) of the Primary Tumor in Metastatic Prostate CancerDouglas S ScherrPIInterventionDrug: Abiraterone · Drug: Bicalutamide · Drug: Degarelix · Drug: Docetaxel · Drug: Flutamide · Drug: Goserelin Acetate · Drug: Histrelin Acetate · Drug: Leuprolide Acetate · Drug: Nilutamide · Procedure: Orchiectomy · Drug: Prednisone · Other: Quality-of-Life Assessment · Radiation: Radiation Therapy · Procedure: Radical Prostatectomy · Drug: TriptorelinDatesSep 2018 – Apr 2033 (est.)SponsorSouthwest Oncology GroupCastration Levels of TestosteroneMetastatic Prostatic AdenocarcinomaStage IV Prostate Cancer AJCC v8+2 more
RecruitingInterventional · Phase 1NCT04167969 ↗Molecular Phenotyping and Image-Guided Surgical Treatment of Prostate Cancer Using Ultrasmall Silica NanoparticlesMichelle S. BradburyPIInterventionDrug: (64Cu)-NOTA-PSMAi-PEG-Cy5.5-C' dot tracer · Diagnostic test: PET/MRI/fluorescence imaging · Other: Blood and urine sampling · Procedure: laparoscopic radical prostatectomy and bilateral pelvic LN dissection or a salvage lymph node dissection · Drug: 89Zr-DFO-PSMAi-PEG-Cy5.5-C' dotsDatesFeb 2021 – Nov 2027 (est.)SponsorMemorial Sloan Kettering Cancer CenterProstate Cancer
Active, not recruitingInterventional · Phase 3NCT04455750 ↗CASPAR - A Phase III Trial of Enzalutamide and Rucaparib as a Novel Therapy in First-Line Metastatic Castration-Resistant Prostate CancerScott T. TagawaPIInterventionDrug: Enzalutamide · Drug: Rucaparib camsylate · Drug: Placebo · Drug: Leuprolide Acetate · Drug: Goserelin Acetate · Drug: Degarelix · Other: Quality-of-Life Assessment · Other: Questionnaire AdministrationDatesOct 2021 – Mar 2027 (est.)SponsorAlliance for Clinical Trials in OncologyCastration-Resistant Prostate CarcinomaMetastatic Prostate AdenocarcinomaStage IV Prostate Cancer AJCC v8+2 more
Active, not recruitingInterventional · Phase 3NCT04513717 ↗Parallel Phase III Randomized Trials for High Risk Prostate Cancer Evaluating De-Intensification for Lower Genomic Risk and Intensification of Concurrent Therapy for Higher Genomic Risk With Radiation (PREDICT-RT*)Scott T. TagawaPIInterventionDrug: Apalutamide · Drug: Bicalutamide · Procedure: Biospecimen Collection · Procedure: Bone Scan · Drug: Buserelin · Procedure: Computed Tomography · Drug: Degarelix · Drug: Flutamide · Drug: Goserelin · Drug: Histrelin · Drug: Leuprolide · Procedure: Magnetic Resonance Elastography · Procedure: Positron Emission Tomography · Other: Quality-of-Life Assessment · Other: Questionnaire Administration · Radiation: Radiation Therapy · Drug: Relugolix · Drug: TriptorelinDatesJan 2021 – Dec 2033 (est.)SponsorNRG OncologyProstate AdenocarcinomaStage III Prostate Cancer AJCC v8Stage IVA Prostate Cancer AJCC v8
Active, not recruitingInterventional · Phase 1/2NCT05067140 ↗A Phase 1/2 Open-Label, Dose-Escalation and Cohort Expansion Clinical Trial to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of ARV-766 Monotherapy and in Combination With Abiraterone in Patients With Metastatic Prostate CancerCora SternbergPIInterventionDrug: ARV-766 · Drug: Abiraterone · Drug: Corticosteroid (e.g., prednisone/prednisolone) · Other: Androgen Deprivation Therapy (ADT)DatesSep 2021 – May 2027 (est.)SponsorArvinas Androgen Receptor, IncProstate Cancer Metastatic
RecruitingInterventional · Phase 3NCT05946213 ↗The Phase III 'High Five Trial' Five Fraction Radiation For High-Risk Prostate CancerHani Lamie AshamallaPIInterventionProcedure: Biospecimen Collection · Procedure: Bone Scan · Procedure: Computed Tomography · Radiation: External Beam Radiation Therapy · Procedure: Magnetic Resonance Imaging · Procedure: Positron Emission Tomography · Other: Quality-of-Life Assessment · Other: Questionnaire Administration · Radiation: Stereotactic Body Radiation TherapyDatesDec 2023 – Mar 2036 (est.)SponsorNRG OncologyProstate AdenocarcinomaStage III Prostate Cancer AJCC v8Stage IVA Prostate Cancer AJCC v8
TerminatedObservationalNCT04293406 ↗WCM Catchment Prostate Cancer Health Impact Program (pCHIP)Joseph Reginald OsbornePIInterventionOther: Decision Navigation Intervention (DNI)DatesFeb 2021 – Apr 2024SponsorWeill Medical College of Cornell UniversityProstate Cancer
CompletedInterventional · Phase 2NCT04600336 ↗A Randomized, Double-Blind, Placebo-Controlled Phase II Study of Oxybutynin Versus Placebo for the Treatment of Hot Flashes in Men Receiving Androgen Deprivation TherapyScott T. TagawaPIInterventionDrug: Oxybutynin Chloride · Drug: Placebo Administration · Other: Quality-of-Life Assessment · Other: Questionnaire AdministrationDatesOct 2021 – Feb 2024· Results postedSponsorAlliance for Clinical Trials in OncologyProstate Carcinoma
CompletedObservationalNCT04890314 ↗Prostate Cancer - Comparative Outcomes of New Conceptual Paradigms for TreatmentJim C. HuPIInterventionOther: Patient-reported questionnaireDatesMay 2021 – Apr 2024· Results postedSponsorWeill Medical College of Cornell UniversityProstate Cancer