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NCT04691804 · ClinicalTrials.gov registry record · Phase 3
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
A Phase 3 study of Metastatic Castration-Resistant Prostate Cancer (mCRPC), sponsored by Jiangsu HengRui Medicine Co..
- Active
- Registry status
- Phase 3
- Development phase
- 496
- Enrollment target
- 20
- Study locations
NCT04691804: Active Phase 3 study of Metastatic Castration-Resistant Prostate Cancer (mCRPC), sponsored by Jiangsu HengRui Medicine Co..
NCT04691804 is a Phase 3 study of Metastatic Castration-Resistant Prostate Cancer (mCRPC) that is active but no longer recruiting, run by Jiangsu HengRui Medicine Co.. The registered enrollment target is 496 participants, above the 380-participant average among 15 other Metastatic Castration-Resistant Prostate Cancer (mCRPC) trials with a reported enrollment target (31% higher). The trial reports 20 study locations across 16 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04691804, a Phase 3 study of Metastatic Castration-Resistant Prostate Cancer (mCRPC), is active but no longer recruiting, sponsored by Jiangsu HengRui Medicine Co..
- ACTIVE NOT RECRUITING
- Registry status
- Phase 3
- Development phase
- 496 participants
- Enrollment target
- 20
- Study locations
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).
Primary Outcome
progression-free survival
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 |
What the registry record for NCT04691804 still lists
NCT04691804 is an interventional study that assigns participants to a tested intervention. The registered 496 participants enrollment target is mid-sized for trials with a published cap, above the 380-participant average among 15 other Metastatic Castration-Resistant Prostate Cancer (mCRPC) trials with a reported enrollment target (31% higher).
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.
NCT04691804 names 20 study sites across 16 states, led by Other, California, Maryland.
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).
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).
Who is sponsoring clinical trial NCT04691804?
This trial is sponsored by Jiangsu HengRui Medicine Co., which has 8 total clinical trials registered on ClinicalTrials.gov.
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.
Learn More About Clinical Trials
Similar trials for Metastatic Castration-Resistant Prostate Cancer (mCRPC)
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Where NCT04691804's enrollment target sits among peer trials
496 3rd of 15 higher than 13 of 15 other Metastatic Castration-Resistant Prostate Cancer (mCRPC) trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Metastatic Castration-Resistant Prostate Cancer (mCRPC) trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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