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Closed (no longer recruiting)Last updated: 18 April 2024

FUZUPRO: This phase III trial is evaluating the effectiveness of targeted therapy (fuzuloparib), compared to a placebo, in combination with hormone therapy and steroids (abiraterone acetate and prednisone [AA-P]) in people with metastatic castration-resistant prostate cancerA 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

Clinical summary

Summary

This is a randomised, triple-blind trial with an experimental arm and a placebo comparator arm. In the Experimental Arm, participants will receive Fuzuloparib plus Abiraterone acetate and Prednisone (AA-P). Fuzuloparib will be administered at a dose of 150mg, orally, twice a day. Abiraterone acetate will be administered at a dose of 1000mg, orally, once daily. Prednisone will be administered at a dose of 5mg, orally, twice a day. In the Placebo Comparator Arm, participants will receive a Fuzuloparib placebo plus AA-P. The Fuzuloparib placebo will be administered at a dose of 150mg, orally, twice a day. Abiraterone acetate will be administered at a dose of 1000mg, orally, once daily. Finally, Prednisone will be administered at a dose of 5mg, orally, twice a day.

Conditions

This trial is treating patients with metastatic castration-resistant prostate cancer.

Cancer

Urinary System Cancers Genitourinary

Age

People18+

Phase

III

Trial Acronym

FUZUPRO

More information

Trial Identifiers

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Trial sponsor

Jiangsu HengRui Medicine Co., Ltd.

Scientific Title

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

Eligibility

Inclusion

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

Exclusion

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

Inclusion

  • Your cancer has spread to other parts of the body.
  • You are able to swallow medication by mouth.

Exclusion

  • You have certain types of non-cancer medical conditions.
  • You have had certain treatments, surgical procedures or drugs.
Message

Clinical trials have complex eligibility criteria.

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