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 Cancer
Active, not recruitingInterventional · Phase 3NCT03767244 ↗A Randomized, Double-blind, Placebo-controlled, Phase 3 Study of Apalutamide in Subjects With High-risk, Localized or Locally Advanced Prostate Cancer Who Are Candidates for Radical ProstatectomyJim C. HuPIInterventionDrug: Apalutamide · Drug: Androgen Deprivation Therapy (ADT) · Drug: PlaceboDatesJun 2019 – Dec 2026 (est.)SponsorJanssen Research & Development, LLCProstatic Neoplasms
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 3NCT04647526 ↗A Phase 3, Open-Label, Randomized Study Evaluating Metastatic Castrate Resistant Prostate Cancer Treatment Using PSMA [Lu-177]-PNT2002 Therapy After Second-line Hormonal Treatment (SPLASH)Scott T. TagawaPIInterventionDrug: [Lu-177]-PNT2002 · Drug: Abiraterone · Drug: EnzalutamideDatesFeb 2021 – Nov 2023· Results postedSponsorPOINT Biopharma Inc.Metastatic Castration-Resistant Prostate Cancer
Active, not recruitingInterventional · Phase 3NCT04720157 ↗An Open-label, Randomized, Phase III Study Comparing 177Lu-PSMA-617 in Combination With Standard of Care, Versus Standard of Care Alone, in Adult Male Patients With Metastatic Hormone Sensitive Prostate Cancer (mHSPC)Scott T. TagawaPIInterventionDrug: 177Lu-PSMA-617 · Drug: 68Ga-PSMA-11 · Drug: ARDT · Drug: ADTDatesJun 2021 – Jan 2025· Results postedSponsorNovartis Pharmaceuticals CorporationProstatic Neoplasms
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
RecruitingInterventional · Phase 3NCT06855277 ↗A Phase III, Open-label, Multi-center, Randomized Study Comparing AAA817+ARPI Versus Standard of Care in Adult Participants With PSMA-positive Metastatic Castration Resistant Prostate CancerScott T. TagawaPIInterventionDrug: AAA817 · Drug: ARPI · Drug: Standard of CareDatesJul 2025 – Sep 2028 (est.)SponsorNovartis Pharma AGProstate Cancer
Active, not recruitingInterventional · Phase 3NCT07052214 ↗A Single Arm, Multicenter, Prospective, Open Label, Longitudinal Phase 3 Study of Prostate Specific Membrane Antigen (PSMA) Positron Emission Tomography (PET) Combined With Magnetic Resonance Imaging (MRI) Compared to Standard of Care (SOC) for the Detection of Prostate Cancer (PCa).Joseph Reginald OsbornePIInterventionDrug: 68Ga-PSMA-11DatesAug 2025 – Jan 2027 (est.)SponsorTelix Pharmaceuticals (Innovations) Pty Ltd.PCAProstate CancerProstatic Neoplasm+6 more