A Study of Niraparib Combination Therapies for the Treatment of Metastatic Castration-Resistant Prostate Cancer
Public ClinicalTrials.gov record NCT03431350. 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 1b-2 Study of Niraparib Combination Therapies for the Treatment of Metastatic Castration-Resistant Prostate Cancer
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
The purpose of this study is to: a) establish the recommended phase 2 dose (RP2D) and to evaluate the antitumor activity and safety of niraparib combination therapies (Combinations 1 and 2) and b) to determine the relative bioavailability of niraparib and abiraterone acetate (AA) in combination (Combination 3) in participants with metastatic castration-resistant prostate cancer (mCRPC).
Study identification
- NCT ID
- NCT03431350
- Recruitment status
- Active, not recruiting
- Study type
- Interventional
- Phase
- Phase 2
- Enrollment
- 136 participants
Conditions and interventions
Conditions
Interventions
- Niraparib 200 mg Drug
- Cetrelimab 240 mg Drug
- Cetrelimab 480 mg Drug
- Abiraterone acetate 1000 mg Drug
- Prednisone 5 mg 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
- Mar 1, 2018
- Primary completion
- Aug 30, 2021
- Completion
- Dec 30, 2026
- Last update posted
- Aug 27, 2026
2018 – 2026
United States locations
- U.S. sites
- 19
- U.S. states
- 14
- U.S. cities
- 18
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Urological Associates of Southern Arizona, P.C. | Tucson | Arizona | 85741 | — |
| The Urology Center of Colorado | Denver | Colorado | 80211 | — |
| Mayo Clinic - Division Of Hematology/oncology | Jacksonville | Florida | 32224 | — |
| First Urology, PSC | Jeffersonville | Indiana | 47130 | — |
| Chesapeake Urology Research Associates | Towson | Maryland | 21204 | — |
| Michigan Institute of Urology | Troy | Michigan | 48084 | — |
| New York Oncology Hematology | Albany | New York | 12208 | — |
| Memorial Sloan Kettering Cancer Center 1 | Harrison | New York | 10604 | — |
| Memorial Sloan Kettering Cancer Center | New York | New York | 10065 | — |
| Thomas Jefferson University | Philadelphia | Pennsylvania | 19107 | — |
| University of Pittsburgh Medical Center (UPMC) | Pittsburgh | Pennsylvania | 15232 | — |
| MUSC-Hollings Cancer Center | Charleston | South Carolina | 29425 | — |
| Carolina Urologic Research Center | Myrtle Beach | South Carolina | 29572 | — |
| Urology Associates | Nashville | Tennessee | 37209 | — |
| Houston Metro Urology | Houston | Texas | 77027 | — |
| The University of Texas MD Anderson Cancer Center | Houston | Texas | 77030 | — |
| Utah Cancer Specialists | Salt Lake City | Utah | 84106 | — |
| Urology of Virginia, PLCC | Virginia Beach | Virginia | 23462 | — |
| University of Wisconsin Carbone Cancer Center | Madison | Wisconsin | 5379200 | — |
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 31 non-U.S. sites.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT03431350, 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 Aug 27, 2026 · Synced Sep 2, 2026
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Open the official record
The complete protocol, eligibility criteria, and contact information for NCT03431350 live on ClinicalTrials.gov.