A Multicenter, Randomized, Double-Blind, Placebo-Controlled Phase III Study of Fuzuloparib Combined With Abiraterone Acetate and Prednisone (AA-P) Versus Placebo Combined With AA-P as First-Line Treatment in Patients With Metastatic Castration-Resistant Prostate Cancer
Public ClinicalTrials.gov record NCT04691804. 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.
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
To evaluate whether Fuzuloparib plus AA-P is superior to placebo plus AA-P as first-line treatment by assessment of radiographic progression-free survival (rPFS) in mCRPC subjects unselected for deoxyribonucleic acid (DNA) damage repair deficiencies (DRD) status (Cohort 1) to evaluate whether Fuzuloparib plus AA-P is superior to placebo plus AA-P as first-line treatment by assessment of rPFS in mCRPC subjects harboring DRD (Cohort 2).
Study identification
- NCT ID
- NCT04691804
- Recruitment status
- Active, not recruiting
- Study type
- Interventional
- Phase
- Phase 3
- Enrollment
- 496 participants
Conditions and interventions
Interventions
- Fuzuloparib , Abiraterone acetate and Prednisone Drug
- Fuzuloparib Placebo， Abiraterone acetate and Prednisone 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 17, 2021
- Primary completion
- Dec 30, 2026
- Completion
- Dec 30, 2026
- Last update posted
- Dec 30, 2024
2021 – 2026
United States locations
- U.S. sites
- 17
- U.S. states
- 15
- U.S. cities
- 16
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Alaska Oncology and Hematology LLC | Anchorage | Alaska | 99508 | — |
| Urological Associates of Southern Arizona PC | Tucson | Arizona | 85741 | — |
| Desert Hematology Oncology Medical Group Inc | Rancho Mirage | California | 92270 | — |
| San Bernardino Urological Associates Medical Group | San Bernardino | California | 92404 | — |
| UF College of Medicine - Jacksonville | Jacksonville | Florida | 32209 | — |
| Hematology Oncology Clinic | Baton Rouge | Louisiana | 70809 | — |
| VA Maryland Health Care System | Baltimore | Maryland | 21201 | — |
| Johns Hopkins | Baltimore | Maryland | 21287 | — |
| Henry Ford Health System | Detroit | Michigan | 48202 | — |
| GU Research Network LLC | Omaha | Nebraska | 68130 | — |
| John Theurer Cancer Center | Hackensack | New Jersey | 76011 | — |
| Weill Cornell Medicine | New York | New York | 10021 | — |
| Messino Cancer Centers | Asheville | North Carolina | 28806 | — |
| Gabrail Cancer Center Research | Canton | Ohio | 44718 | — |
| Carolina Urologic Research Center, LLC | Myrtle Beach | South Carolina | 29572 | — |
| Tennessee Oncology | Chattanooga | Tennessee | 37404 | — |
| Center for Onology and Blood Disorders | Houston | Texas | 77030 | — |
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 130 non-U.S. sites.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT04691804, 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 Dec 30, 2024 · Synced Sep 3, 2026
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Open the official record
The complete protocol, eligibility criteria, and contact information for NCT04691804 live on ClinicalTrials.gov.