Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
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
NCT04691804 · View on ClinicalTrials.gov ↗
Study Summary
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).
Conditions Studied
Interventions
- DRUG Fuzuloparib , Abiraterone acetate and Prednisone
- DRUG Fuzuloparib Placebo, Abiraterone acetate and Prednisone
Study Locations (20)
Other
- Bendigo Health — Bendigo
- Concord Repatriation General Hospital — Concord
- St Vincents Hospital Melbourne — Fitzroy
California
- Desert Hematology Oncology Medical Group Inc — Rancho Mirage
- San Bernardino Urological Associates Medical Group — San Bernardino
Maryland
- VA Maryland Health Care System — Baltimore
- Johns Hopkins — Baltimore
Alaska
- Alaska Oncology and Hematology LLC — Anchorage
Arizona
- Urological Associates of Southern Arizona PC — Tucson
Florida
- UF College of Medicine - Jacksonville — Jacksonville
Louisiana
- Hematology Oncology Clinic — Baton Rouge
Michigan
- Henry Ford Health System — Detroit
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 496 participants |
| Start Date | 2021-03-18 |
| Est. Completion | 2026-12-31 |
| Phase | Phase 3 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT04691804
The ClinicalTrials.gov registry entry for NCT04691804 describes a study currently listed as active not recruiting. It is categorized as Phase 3, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 496 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Jiangsu HengRui Medicine Co., which has 4 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
The record links to 1 condition, with Metastatic Castration-Resistant Prostate Cancer (mCRPC) appearing as the primary indexed condition, and to 2 interventions — of which Fuzuloparib , Abiraterone acetate and Prednisone is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT04691804 reports 20 study locations spanning 16 distinct geographic areas — top geographies include Other, California, Maryland. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
Frequently Asked Questions
What is clinical trial NCT04691804 about?
NCT04691804 is a clinical study titled "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". 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 Fuzulo...
What is the current status of trial NCT04691804?
This trial is currently active not recruiting. It is a Phase 3 study. The enrollment target is 496 participants. The study started on 2021-03-18. Estimated completion is 2026-12-31.
What conditions does trial NCT04691804 study?
This clinical trial studies the following conditions: Metastatic Castration-Resistant Prostate Cancer (mCRPC). These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT04691804?
The interventions under investigation include: Fuzuloparib , Abiraterone acetate and Prednisone (DRUG), Fuzuloparib Placebo, Abiraterone acetate and Prednisone (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT04691804?
This trial is sponsored by Jiangsu HengRui Medicine Co., which has 4 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
Where is trial NCT04691804 being conducted?
This trial has 20 study locations across Alaska, Arizona, California, Florida, Louisiana. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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