A Study of Niraparib in Combination With Abiraterone Acetate and Prednisone Versus Abiraterone Acetate and Prednisone for Treatment of Participants With Metastatic Prostate Cancer
Public ClinicalTrials.gov record NCT03748641. 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 in Subjects With Metastatic Prostate Cancer
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
The purpose of this study is to evaluate the effectiveness of niraparib in combination with abiraterone acetate plus prednisone (AAP) compared to AAP and placebo.
Study identification
- NCT ID
- NCT03748641
- Recruitment status
- Active, not recruiting
- Study type
- Interventional
- Phase
- Phase 3
- Enrollment
- 765 participants
Conditions and interventions
Conditions
Interventions
- Niraparib Drug
- Abiraterone Acetate Drug
- Prednisone Drug
- Placebo Drug
- New Formulation of Niraparib and Abiraterone Acetate (AA) Drug
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
- Jan 25, 2019 (Actual)
- Primary completion
- Oct 8, 2021 (Actual)
- Completion
- Dec 31, 2027 (Estimated)
- Last update posted
- Sep 25, 2026
2019 – 2027
United States locations
- U.S. sites
- 47
- U.S. states
- 29
- U.S. cities
- 43
| 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 | — |
| Arkansas Urology | Little Rock | Arkansas | 72211 | — |
| Kaiser Permanente | Riverside | California | 92505 | — |
| San Bernardino Urological Associates | San Bernardino | California | 92404 | — |
| University of California San Francisco | San Francisco | California | 94158 | — |
| Sansum Clinic Pharm | Santa Barbara | California | 93105 | — |
| The Urology Center of Colorado | Denver | Colorado | 80211 | — |
| Colorado Clinical Research | Lakewood | Colorado | 80228 | — |
| VA Connecticut Healthcare | West Haven | Connecticut | 06516 | — |
| Bay Pines VA Healthcare System | Bay Pines | Florida | 33744 | — |
| Advanced Urology Institute | Daytona Beach | Florida | 32114 | — |
| University of Florida Health Jacksonville | Jacksonville | Florida | 32209 | — |
| Mayo Clinic - Division Of Hematology/oncology | Jacksonville | Florida | 32224 | — |
| Veterans Affairs Medical Ctr | Hines | Illinois | 60141 | — |
| Fort Wayne Medical Oncology and Hematology | Fort Wayne | Indiana | 46825 | — |
| First Urology | Jeffersonville | Indiana | 47130 | — |
| University of Kansas Medical Center | Kansas City | Kansas | 66160 | — |
| Norton Healthcare | Louisville | Kentucky | 40202 | — |
| Ochsner Clinic Foundation | New Orleans | Louisiana | 70121 | — |
| Rcca Md, Llc | Bethesda | Maryland | 20817 | — |
| Chesapeake Urology Research Associates | Towson | Maryland | 21204 | — |
| Massachusetts General | Boston | Massachusetts | 02114 | — |
| Michigan Institute of Urology | Troy | Michigan | 48084 | — |
| Kansas City Veterans Affairs Medical Center | Kansas City | Missouri | 64128 | — |
| Adult Pediatric Urology & Urogynecology, P.C | Omaha | Nebraska | 68114 | — |
| Nebraska Cancer Specialists | Omaha | Nebraska | 68130 | — |
| Comprehensive Cancer Centers of Nevada | Las Vegas | Nevada | 89169 | — |
| Delaware Valley Urology, LLC | Mount Laurel | New Jersey | 08054 | — |
| New York Oncology Hematology | Albany | New York | 12208 | — |
| Icahn School of Medicine at Mount Sinai - The Derald H. Ruttenberg | New York | New York | 10029 | — |
| Memorial Sloan Kettering Cancer Center | New York | New York | 10065 | — |
| Upstate Cancer Center | Syracuse | New York | 13210 | — |
| Helios Clinical Research, LLC | Middleburg Heights | Ohio | 44130 | — |
| Oregon Urology Institute | Springfield | Oregon | 97477 | — |
| MidLantic Urology | Bala-Cynwyd | Pennsylvania | 19004 | — |
| Lancaster Urology | Lancaster | Pennsylvania | 17604 | — |
| VA Pittsburgh | Pittsburgh | Pennsylvania | 15240 | — |
| Carolina Urologic Research Center | Myrtle Beach | South Carolina | 29572 | — |
| Urology Associates | Nashville | Tennessee | 37209 | — |
| Houston Metro Urology | Houston | Texas | 77027 | — |
| University of Texas MD Anderson Cancer Center | Houston | Texas | 77030 | — |
| Utah Cancer Specialists | Salt Lake City | Utah | 84106 | — |
| Salem VA Medical Center | Salem | Virginia | 80113 | — |
| Urology of Virginia, PLCC | Virginia Beach | Virginia | 23462 | — |
| NorthWest Medical Specialties, PLLC | 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 271 non-U.S. sites.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT03748641, 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 25, 2026 · Synced Oct 19, 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 NCT03748641 live on ClinicalTrials.gov.