High-Risk Metachronous Oligometastatic Prostate Cancer Trial
NCT06212583 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 88
Last updated 2026-05-06
Summary
The purpose of this research study is to compare the effects, good and/or bad, of using the standard of care treatment, hormonal therapy + Stereotactic Ablative Radiation (SABR) to the metastatic lesions, compared to standard of care and addition of 6-months of niraparib/abiraterone acetate combination pills and prednisone for participants with recurrent metastatic prostate cancer.
Conditions
- Prostate Cancer
- Oligometastatic Disease
Interventions
- DRUG
-
niraparib/abiraterone acetate
Patients on Arm 2 to receive drug for 6 months
- RADIATION
-
Stereotactic ablative radiation therapy (SABR)
Both arms will receive SABR
- DRUG
-
Androgen deprivation therapy (ADT)
All ADT is provided as best prescribed for patient per their medical oncologist.
Sponsors & Collaborators
-
Janssen Scientific Affairs, LLC
collaborator INDUSTRY -
University of Maryland, Baltimore
lead OTHER
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Sex
- MALE
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2024-04-17
- Primary Completion
- 2028-12-31
- Completion
- 2029-12-31
- FDA Drug
- Yes
Countries
- United States
Study Locations
More Related Trials
-
Niraparib, Abiraterone Acetate and Prednisone for mHSPC With Deleterious Homologous Recombination Repair Alterations
NCT06392841 ·Status: WITHDRAWN ·Phase: PHASE2
-
Systemic and Tumor-Directed Therapy for Oligometastatic Prostate Cancer
NCT03298087 ·Status: COMPLETED ·Phase: PHASE2
-
Abiraterone Acetate and Prednisone With or Without Dasatinib in Treating Patients With Metastatic Hormone-Resistant Prostate Cancer
NCT01685125 ·Status: UNKNOWN ·Phase: PHASE2
-
Pembrolizumab With Androgen Deprivation Therapy and Radiotherapy for the Treatment of Patients With High Risk Localized Prostate Cancer
NCT06528210 ·Status: WITHDRAWN ·Phase: PHASE2
-
A Phase 2 Study to Evaluate Safety and Efficacy of Abiraterone in Participants With Prostate Cancer Who Have Received Docetaxel
NCT01795703 ·Status: COMPLETED ·Phase: PHASE2
-
Study of Abiraterone Acetate or Enzalutamide, Atezolizumab, GnRH Analog and Radiation Therapy in Men With Newly Diagnosed Hormone-sensitive Prostate Cancer
NCT04262154 ·Status: ACTIVE_NOT_RECRUITING ·Phase: PHASE2
-
A Multicenter Phase I/II Trial of Abiraterone Acetate + BEZ235 in Metastatic, Castration-Resistant Prostate Cancer
NCT01717898 ·Status: TERMINATED ·Phase: PHASE1/PHASE2
-
Study of Abiraterone Acetate Without Exogenous Glucocorticoids in Men With Castration-resistant Prostate Cancer
NCT02025010 ·Status: COMPLETED ·Phase: PHASE2
-
Combination Immunotherapy in Biochemically Recurrent Prostate Cancer
NCT03315871 ·Status: COMPLETED ·Phase: PHASE2
-
Study of Abiraterone Acetate Plus ADT Versus APALUTAMIDE Versus Abiraterone and APALUTAMIDE in Patients With Advanced Prostate Cancer With Non-castrate Testosterone Levels
NCT02867020 ·Status: COMPLETED ·Phase: PHASE2
-
Abiraterone Acetate, Niclosamide, and Prednisone in Treating Patients With Hormone-Resistant Prostate Cancer
NCT02807805 ·Status: ACTIVE_NOT_RECRUITING ·Phase: PHASE2
-
Mitoxantrone Following Surgery in Treating Patients With Prostate Cancer at High Risk for Recurrence
NCT00003858 ·Status: WITHDRAWN ·Phase: PHASE2
-
Adjuvant Androgen Suppression Plus Radiation Therapy for High-Risk Localized Adenocarcinoma Prostate
NCT01255891 ·Status: COMPLETED ·Phase: PHASE2
-
Docetaxel to Androgen Receptor Pathway Inhibitors in Patients With Metastatic Castration Sensitive Prostate Cancer and Suboptimal PSA Response
NCT06592924 ·Status: RECRUITING ·Phase: PHASE3
-
Finite Androgen Ablation With or Without Abiraterone Acetate and Prednisone in Treating Patients With Recurrent Prostate Cancer
NCT01786265 ·Status: ACTIVE_NOT_RECRUITING ·Phase: PHASE2
-
Abiraterone, Radiotherapy and Short-Term Androgen Deprivation in Unfavorable Localized Prostate Cancer
NCT01717053 ·Status: COMPLETED ·Phase: PHASE2
-
A Study of Androgen Annihilation in High-Risk Biochemically Relapsed Prostate Cancer
NCT03009981 ·Status: COMPLETED ·Phase: PHASE3
-
Androgen Ablation Therapy With or Without Vaccine Therapy in Treating Patients With Prostate Cancer
NCT00771017 ·Status: WITHDRAWN ·Phase: PHASE2
-
S1014 Abiraterone Acetate in Treating Patients With Prostate Cancer Who Have Undergone Initial Hormone Therapy
NCT01309672 ·Status: COMPLETED ·Phase: PHASE2
-
Standard Systemic Therapy With or Without Definitive Treatment in Treating Participants With Metastatic Prostate Cancer
NCT03678025 ·Status: RECRUITING ·Phase: PHASE3
-
Dose-Seeking Trial of PCK3145 in Asymptomatic, Castrate Metastatic Prostate Cancer Patients.
NCT00695851 ·Status: COMPLETED ·Phase: PHASE1
-
Study of Abraxane Plus Hormonal Therapy as Initial Treatment of Unresectable or Metastatic Prostate Cancer
NCT00521781 ·Status: TERMINATED ·Phase: PHASE2
-
A Study of Niraparib in Combination With Abiraterone Acetate and Prednisone Versus Abiraterone Acetate and Prednisone for Treatment of Participants With Metastatic Prostate Cancer
NCT03748641 ·Status: ACTIVE_NOT_RECRUITING ·Phase: PHASE3
-
Apalutamide, Abiraterone Acetate, and Prednisone in Treating Participants With Metastatic Castration Resistant Prostate Cancer
NCT03360721 ·Status: TERMINATED ·Phase: PHASE2
-
Multi-arm Multi-modality Therapy for Very High Risk Localized and Low Volume Metastatic Prostatic Adenocarcinoma
NCT03436654 ·Status: ACTIVE_NOT_RECRUITING ·Phase: PHASE2