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*)
Active, not recruitingInterventional · Not applicableNCT03561220 ↗A Prospective Comparative Study of Outcomes With Proton and Photon Radiation in Prostate CancerBaoqing LiPIInterventionRadiation: Standard of Care IMRT (Photon) · Radiation: Standard of Care Proton Therapy · Radiation: Proton Arm 1: Standard Proton Therapy · Radiation: Proton Arm 2: Hypofractionated Proton TherapyDatesJul 2018 – Feb 2026SponsorUniversity of Florida Health - JacksonvilleProstate Cancer
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
Active, not recruitingInterventional · Phase 1/2NCT04194554 ↗A Multi-Center Trial of Androgen Suppression With Abiraterone aCetate, LEuprolide, PARP Inhibition and Stereotactic Body Radiotherapy (ASCLEPIuS): A Phase I/2 Trial in High Risk and Node Positive Prostate CancerScott T. TagawaPIInterventionDrug: Niraparib · Drug: Leuprolide · Drug: Abiraterone Acetate · Radiation: Stereotactic body radiotherapy (SBRT)DatesNov 2020 – May 2027 (est.)SponsorUniversity of MichiganProstate Cancer
RecruitingInterventional · Phase 2NCT04402151 ↗Single-Arm Phase II Study of PSMA PET/MR Guided Stereotactic Body Radiation Therapy With Simultaneous Integrated Boost (SBRT-SIB) for High-Intermediate and High Risk Prostate CancerSilvia Chiara FormentiPIInterventionDrug: PSMA PET/MR - Gallium-68 labeled PSMA-HBED-CC · Radiation: Stereotactic Body Radiation Therapy (SBRT)DatesJun 2020 – Dec 2027 (est.)SponsorWeill Medical College of Cornell UniversityProstate Cancer
Active, not recruitingInterventional · Phase 2NCT04422132 ↗Randomized Phase II Trial of Salvage Radiotherapy for Prostate Cancer In 4 Weeks v. 2 WeeksEmily WegPIInterventionRadiation: 5 days Radiation Therapy (32.5 Gy in 5 fractions) · Radiation: 20 days Radiation therapy (55 Gy in 20 fractions)DatesSep 2020 – Dec 2025· Results postedSponsorWeill Medical College of Cornell UniversityProstate Cancer
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
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
CompletedInterventional · Phase 1/2NCT04037254 ↗Randomized Phase II Trial of Niraparib With Standard Combination Radiotherapy and Androgen Deprivation Therapy (ADT) in High Risk Prostate Cancer (With Initial Phase I) (NADIR*) *Randomized Phase II Trial of Niraparib With Standard Combination Androgen DeprIvation Therapy (ADT) and Radiotherapy in High Risk Prostate Cancer (With Initial Phase I)David A. GreenPIInterventionBiological: Gonadotrophin Releasing Hormone · Radiation: Intensity-Modulated Radiation Therapy · Drug: NiraparibDatesOct 2019 – Jul 2024· Results postedSponsorNRG OncologyProstate AdenocarcinomaStage IIC Prostate Cancer AJCC v8Stage III Prostate Cancer AJCC v8+4 more
CompletedInterventional · Not applicableNCT04220983 ↗PRAGMA (Prostate Radio Ablation Guided by Magnetic Resonance Imaging Acquisition) in Metastatic Prostate CancerSilvia Chiara FormentiPIInterventionRadiation: MR-Guided Prostate SBRTDatesJan 2020 – Feb 2023· Results postedSponsorWeill Medical College of Cornell UniversityMetastatic Prostate Cancer
TerminatedInterventional · Phase 2NCT04984343 ↗Randomized Phase II Trial of Five or Two MRI-Guided Adaptive Radiotherapy Treatments for Prostate CancerEmily WegPIInterventionRadiation: Radiation TherapyDatesFeb 2022 – Dec 2025SponsorWeill Medical College of Cornell UniversityProstate Cancer