A Study of Niraparib in Combination With Abiraterone Acetate and Prednisone Versus Abiraterone Acetate and Prednisone for the Treatment of Participants With Deleterious Germline or Somatic Homologous Recombination Repair (HRR) Gene-Mutated Metastatic Castration-Sensitive Prostate Cancer (mCSPC)
Running, not enrolling · Phase 3 · Has a placebo group
Conditions studied: Metastatic Castration-sensitive Prostate Cancer
In brief
The purpose of the study is to determine if the combination of niraparib with Abiraterone Acetate (AA) plus prednisone compared with AA plus prednisone in participants with deleterious germline or somatic Homologous Recombination Repair (HRR) gene-mutated Metastatic Castration-Sensitive Prostate Cancer (mCSPC) provides superior efficacy in improving radiographic progression-free survival (rPFS).
Key facts
- Study ID
- NCT04497844
- Run by
- Janssen Research & Development, LLC
- People needed
- 696
- Starts
- 2020-09-23
- Expected to finish
- 2027-11-01
- Last updated by the study team
- 2026-07-06
Who can join
Age: 18 and older. Sex: male. Healthy volunteers: not accepted.
You may qualify if…
- Pathological diagnosis of prostate adenocarcinoma
- Must have appropriate deleterious homologous recombination repair (HRR) gene alteration
- Metastatic disease as documented by conventional imaging with computed tomography (CT) or magnetic resonance imaging (MRI) (for soft tissue lesions) or 99mTc bone scan (for bone lesions). Participants with a single bone lesion on Technetium-99m (99mTc) bone scan with no other non-nodal metastatic disease must have confirmation of bone metastasis by CT or MRI. Participants with lymph node-only disease are not eligible
- Androgen deprivation therapy (either medical or surgical castration) must have been started >=14 days prior to randomization and participants be willing to continue androgen deprivation therapy (ADT) through the treatment phase
- Other allowed prior therapy for metastatic castration-sensitive prostate cancer (mCSPC): (a) maximum of 1 course of radiation and 1 surgical intervention for symptomatic control of prostate cancer (example, uncontrolled pain, impending spinal cord compression or obstructive symptoms). Participants with radiation or surgical interventions to all known sites of metastatic disease will be excluded from trial participation. Radiation must be completed prior to randomization (b) Up to a maximum of 6 months of ADT prior to randomization; (c) Up to a maximum of 45 days of abiraterone acetate + prednisone (AA-P) prior to randomization (d) Up to a maximum of 2 weeks of ketoconazole for prostate cancer prior to randomization
You may not qualify if…
- Prior treatment with a poly (adenosine diphosphate-ribose) polymerase inhibitor (PARP inhibitor)
- History of adrenal dysfunction
- Long-term use of systemically administered corticosteroids (greater than [>] 5 milligrams [mg] of prednisone or the equivalent) during the study is not allowed. Short-term use (<=4 weeks, including taper) and locally administered steroids (for example, inhaled, topical, ophthalmic, and intra-articular) are allowed, if clinically indicated
- History or current diagnosis of myelodysplastic syndrome (MDS)/ acute myeloid leukemia (AML)
Where it is running
- Mayo Clinic Arizona — Phoenix, Arizona, United States
- Urological Associates of Southern Arizona, P.C. — Tucson, Arizona, United States
- Greater Los Angeles VA Healthcare System — Los Angeles, California, United States
- University of California Irvine Medical Center Chao Family Comprehensive Cancer Center — Orange, California, United States
- San Bernardino Urological Associates — San Bernardino, California, United States
- University of San Francisco California — San Francisco, California, United States
- Rocky Mountain Cancer Centers — Colorado Springs, Colorado, United States
- AdventHealth Medical Group Urology of Denver — Denver, Colorado, United States
- Colorado Clinical Research — Lakewood, Colorado, United States
- Eastern Connecticut Hematology & Oncology Assoc. — Norwich, Connecticut, United States
- Advanced Urology Institute — Daytona Beach, Florida, United States
- Holy Cross Hospital - Michael and Dianne Bienes Comprehensive Cancer Center — Fort Lauderdale, Florida, United States
- University of Florida Health Jacksonville — Jacksonville, Florida, United States
- Cancer Specialists of North Florida — Jacksonville, Florida, United States
- Urology of Indiana — Greenwood, Indiana, United States
- First Urology — Jeffersonville, Indiana, United States
- Ochsner Clinic Foundation — New Orleans, Louisiana, United States
- Baltimore VA Medical Center — Baltimore, Maryland, United States
- Maryland Oncology Hematology, PA — Columbia, Maryland, United States
- Chesapeake Urology Associates — Towson, Maryland, United States
- Michigan Institute of Urology — Troy, Michigan, United States
- Mosaic Life Care — Saint Joseph, Missouri, United States
- St. Louis VA Medical Center — St Louis, Missouri, United States
- GU Research Network — Omaha, Nebraska, United States
- Urology Centers Of Alabama — Homewood, Alabama, United States
Full record on ClinicalTrials.gov
Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.