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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 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.
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).
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 |
Interested in This Trial?
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, categorized as Phase 3. The registered enrollment target is 496 participants, a figure that helps gauge the scale of data the investigators plan to collect, above the 380-participant average among 15 other Metastatic Castration-Resistant Prostate Cancer (mCRPC) trials with a reported enrollment target (31% higher). The listed sponsor is Jiangsu HengRui Medicine Co., which has 8 total studies on file at ClinicalTrials.gov.
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 reports 20 study locations spanning 16 distinct geographic areas - top geographies include 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.
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