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-MutatedProstatic Neoplasms (mCSPC)
Public ClinicalTrials.gov record NCT04497844. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
A Phase 3 Randomized, Placebo-controlled, Double-blind 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)
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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).
Study identification
- NCT ID
- NCT04497844
- Recruitment status
- Active, not recruiting
- Study type
- Interventional
- Phase
- Phase 3
- Enrollment
- 696 participants
Conditions and interventions
Conditions
Interventions
- Niraparib+ Abiraterone acetate fixed dose combination (FDC) Combination Product
- Abiraterone acetate (AA) Drug
- Prednisone Drug
- Placebo FDC Drug
- Placebo AA Drug
Combination Product · Drug
Eligibility (public fields only)
- Age range
- 18 Years and older
- Sex
- Male
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Sep 23, 2020 (Actual)
- Primary completion
- Jan 7, 2025 (Actual)
- Completion
- Nov 1, 2027 (Estimated)
- Last update posted
- Sep 28, 2026
2020 – 2027
United States locations
- U.S. sites
- 53
- U.S. states
- 23
- U.S. cities
- 48
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Urology Centers Of Alabama | Homewood | Alabama | 35209 | — |
| Mayo Clinic Arizona | Phoenix | Arizona | 85054 | — |
| Urological Associates of Southern Arizona, P.C. | Tucson | Arizona | 85741 | — |
| Greater Los Angeles VA Healthcare System | Los Angeles | California | 90073 | — |
| University of California Irvine Medical Center Chao Family Comprehensive Cancer Center | Orange | California | 92868 | — |
| San Bernardino Urological Associates | San Bernardino | California | 92404 | — |
| University of San Francisco California | San Francisco | California | 94158 | — |
| Rocky Mountain Cancer Centers | Colorado Springs | Colorado | 80907 | — |
| AdventHealth Medical Group Urology of Denver | Denver | Colorado | 80210 | — |
| Colorado Clinical Research | Lakewood | Colorado | 80228 | — |
| Eastern Connecticut Hematology & Oncology Assoc. | Norwich | Connecticut | 06360 | — |
| Advanced Urology Institute | Daytona Beach | Florida | 32114 | — |
| Holy Cross Hospital - Michael and Dianne Bienes Comprehensive Cancer Center | Fort Lauderdale | Florida | 33308 | — |
| University of Florida Health Jacksonville | Jacksonville | Florida | 32209 | — |
| Cancer Specialists of North Florida | Jacksonville | Florida | 32256 | — |
| Urology of Indiana | Greenwood | Indiana | 46143 | — |
| First Urology | Jeffersonville | Indiana | 47130 | — |
| Ochsner Clinic Foundation | New Orleans | Louisiana | 70121 | — |
| Baltimore VA Medical Center | Baltimore | Maryland | 21201 | — |
| Maryland Oncology Hematology, PA | Columbia | Maryland | 21044 | — |
| Chesapeake Urology Associates | Towson | Maryland | 21204 | — |
| Michigan Institute of Urology | Troy | Michigan | 48084 | — |
| Mosaic Life Care | Saint Joseph | Missouri | 64507 | — |
| St. Louis VA Medical Center | St Louis | Missouri | 63109 | — |
| GU Research Network | Omaha | Nebraska | 68130 | — |
| New York Oncology Hematology | Albany | New York | 12206 | — |
| Manhattan VAMC | New York | New York | 10010 | — |
| Mount Sinai | New York | New York | 10029 | — |
| Memorial Sloan Kettering Cancer Center | New York | New York | 10065 | — |
| Associated Medical Professionals | Syracuse | New York | 13210 | — |
| Montefiore Medical Center | The Bronx | New York | 10461 | — |
| Durham VAMC | Durham | North Carolina | 27705 | — |
| Stephenson Cancer Center | Oklahoma City | Oklahoma | 73104 | — |
| VA Portland Health Care System | Portland | Oregon | 97239 | — |
| Oregon Oncology Specialists | Salem | Oregon | 97301 | — |
| Keystone Urology Specialists | Lancaster | Pennsylvania | 17604 | — |
| Philadelphia VA Medical Center | Philadelphia | Pennsylvania | 19104 | — |
| University of Pennsylvania | Philadelphia | Pennsylvania | 19104 | — |
| University of Pittsburgh Medical Center (UPMC) | Pittsburgh | Pennsylvania | 15232 | — |
| Ralph H. Johnson Veterans Affairs Medical Center | Charleston | South Carolina | 29401 | — |
| Prisma Health | Seneca | South Carolina | 29672 | — |
| Urology Associates | Nashville | Tennessee | 37209 | — |
| Texas Oncology-Austin | Austin | Texas | 78731 | — |
| Texas Oncology - Northeast | Denton | Texas | 76201 | — |
| Houston Metro Urology | Houston | Texas | 77027 | — |
| Texas Oncology P A | New Braunfels | Texas | 78130 | — |
| Texas Oncology - Northeast 1 | Tyler | Texas | 75702 | — |
| University of Utah Huntsman Cancer Institute | Salt Lake City | Utah | 84112 | — |
| Virginia Oncology Associates | Norfolk | Virginia | 23502 | — |
| Virginia Commonwealth University - Massey Cancer Center | Richmond | Virginia | 23298 | — |
| VA Puget Sound Healthcare System | Seattle | Washington | 98108 | — |
| Fred Hutchinson Cancer Research Center | Seattle | Washington | 98109 | — |
| MultiCare Health System | Tacoma | Washington | 98405 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
Non-U.S. locations
This page focuses on the U.S. directory. The official record also lists 334 non-U.S. sites.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT04497844, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Sep 28, 2026 · Synced Oct 25, 2026
Related: full search, browse by condition, browse by drug or therapy, browse by sponsor, browse by U.S. city.
Open the official record
The complete public registry record, listed eligibility criteria, and available contact information for NCT04497844 live on ClinicalTrials.gov.