OncoMatch/Clinical Trials/NCT04947254
Androgen Ablation Therapy With or Without Niraparib After Radiation Therapy for the Treatment of High-Risk Localized or Locally Advanced Prostate Cancer
Is NCT04947254 recruiting? Yes, currently enrolling (May 2026). This Phase 2 trial studies multiple treatments for prostate carcinoma.
Treatment: Abiraterone Acetate · Antiandrogen Therapy · Apalutamide · Niraparib · Prednisone — This phase II trial studies the effect of androgen ablation therapy with or without niraparib after standard of care radiation therapy in treating patients with prostate cancer that has not spread to other parts of the body (localized) or that has spread to nearby tissue or lymph nodes (locally advanced). Androgen ablation therapy (also known as hormone therapy) lowers the levels of male hormones called androgens in the body. Androgens stimulate prostate cancer cells to grow. There are 2 types of androgen ablation therapy given in this study: AAP + ADT and Apa + ADT. AAP + ADT is the treatment combination of the drugs abiraterone acetate and prednisone (AAP) given with androgen deprivation therapy (ADT, also known as androgen deprivation therapy or androgen suppression medication, which is used as standard of care to lower testosterone levels in men with high risk localized or metastatic prostate cancer). Apa + ADT is the treatment combination of the drug apalutamide (Apa) given with ADT. Androgen ablation therapy with or without niraparib after radiation therapy may help to control the disease in patients with prostate cancer.
Check if I qualifyExtracted eligibility criteria
Cancer type
Prostate Cancer
Disease stage
Required: Stage IIC, III, IIIA, IIIB, IIIC, IVA
Grade: 4-5 (gleason score)
Performance status
ECOG 0–2(Ambulatory, capable of self-care)
Prior therapy
Cannot have received: systemic treatment for prostate cancer
Exception: ADT started within 6 months of trial enrollment
Any prior systemic treatment for prostate cancer with the exception of ADT started within 6 months of trial enrollment
Cannot have received: PARP inhibitor
Any prior PARP inhibitor therapy
Cannot have received: surgery (prostatectomy)
Patients who have had prior major surgery (prostatectomy) ... for the treatment of prostate cancer
Cannot have received: radiation therapy
Patients who have had prior ... radiotherapy for the treatment of prostate cancer
Lab requirements
Blood counts
Hemoglobin ≥ 10.0 g/dL; ANC ≥ 1.5 x 10^9/L; WBC > 3 x 10^9/L; Platelet count ≥ 100 x 10^9/L; No features suggestive of MDS/AML on peripheral blood smear
Kidney function
Calculated creatinine clearance (Cockcroft-Gault Equation) ≥ 30 mL/min
Liver function
Total bilirubin ≤ 1.5 x institutional upper limit of normal (ULN) (except for patients with known Gilbert's disease). AST and ALT ≤ 2.5 x institutional ULN
Patients must have adequate organ and bone marrow function measured within 7 days prior to treatment registration as defined below: Hemoglobin ≥ 10.0 g/dL; ANC ≥ 1.5 x 10^9/L; WBC > 3 x 10^9/L; Platelet count ≥ 100 x 10^9/L; Total bilirubin ≤ 1.5 x institutional upper limit of normal (ULN) (except for patients with known Gilbert's disease). AST and ALT ≤ 2.5 x institutional ULN; Calculated creatinine clearance (Cockcroft-Gault Equation) ≥ 30 mL/min
Structured fields extracted by AI. May contain errors — verify against the official protocol.
US trial sites
- M D Anderson Cancer Center · Houston, Texas
Showing up to 5 US sites. See all sites on ClinicalTrials.gov →
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