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

Running, not enrolling · Phase 3 · Has a placebo group

Conditions studied: Metastatic Castration-Resistant Prostate Cancer (mCRPC)

In brief

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).

Key facts

Study ID

NCT04691804

Run by

Jiangsu HengRui Medicine Co., Ltd.

People needed

496

Starts

2021-03-18

Expected to finish

2026-12-31

Last updated by the study team

2024-12-31

Who can join

Age: 18 and older. Sex: male. Healthy volunteers: not accepted.

You may qualify if…

• Able and willing to provide a written informed consent
• A score of 0 to 1 for ECOG performance status
• Age of ≥ 18 years old
• Prostate adenocarcinoma confirmed
• Disease progression of metastatic prostate cancer while the subject was on androgen deprivation therapy.
• The functional level of the organs must meet the requirements
• Blood and tumor tissue samples are provided during screening to determine the DRD status

You may not qualify if…

• Prior treatment with any PARP inhibitor
• Have received any systemic anti-tumor treatment during the mCRPC stage or non-metastatic CRPC stage
• Have used any CYP3A4 inducers or inhibitors within 14 days prior to the first dose
• Plan to receive any other anti-tumor treatment
• Presence of radiologically confirmed tumor lesions in the brain
• Contraindications to the use of Prednisone
• History of uncontrolled pituitary or adrenal dysfunction
• Uncontrolled hypertension
• Presence of active heart diseases
• Human immunodeficiency virus-positive
• Presence of dysphagia, chronic diarrhea, intestinal obstruction, or other factors affecting drug intake and absorption
• Active HBV or HCV infection
• Presence of concomitant diseases

Where it is running

• Urological Associates of Southern Arizona PC — Tucson, Arizona, United States
• Desert Hematology Oncology Medical Group Inc — Rancho Mirage, California, United States
• San Bernardino Urological Associates Medical Group — San Bernardino, California, United States
• UF College of Medicine - Jacksonville — Jacksonville, Florida, United States
• Hematology Oncology Clinic — Baton Rouge, Louisiana, United States
• VA Maryland Health Care System — Baltimore, Maryland, United States
• Johns Hopkins — Baltimore, Maryland, United States
• Henry Ford Health System — Detroit, Michigan, United States
• GU Research Network LLC — Omaha, Nebraska, United States
• John Theurer Cancer Center — Hackensack, New Jersey, United States
• Weill Cornell Medicine — New York, New York, United States
• Messino Cancer Centers — Asheville, North Carolina, United States
• Gabrail Cancer Center Research — Canton, Ohio, United States
• Carolina Urologic Research Center, LLC — Myrtle Beach, South Carolina, United States
• Tennessee Oncology — Chattanooga, Tennessee, United States
• Center for Onology and Blood Disorders — Houston, Texas, United States
• Bendigo Health — Bendigo, Australia
• Concord Repatriation General Hospital — Concord, Australia
• St Vincents Hospital Melbourne — Fitzroy, Australia
• Gosford Hospital — Gosford, Australia
• Ashford Cancer Centre Research — Kurralta Park, Australia
• The Alfred Hospital — Melbourne, Australia
• Western Health — St Albans, Australia
• Macquarie University — Sydney, Australia
• Alaska Oncology and Hematology LLC — Anchorage, Alaska, United States

Full record on ClinicalTrials.gov

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