Study on Fuzuloparib with Abiraterone and Prednisone for First-Line Treatment of Metastatic Castration-Resistant Prostate Cancer

Sponsor: Jiangsu HengRui Medicine Co., Ltd.

Sponsor score: 0
Inactive

ClinicalTrials ID:NCT04691804

Provider View

This clinical trial is testing whether the drug Fuzuloparib, when combined with Abiraterone and Prednisone, is more effective than a placebo combined with these drugs as a first treatment for patients with metastatic castration-resistant prostate cancer.

Patient Parameters

Program Overview

The purpose of this study is to find out if the combination of Fuzuloparib with Abiraterone and Prednisone (AA-P) is better at controlling metastatic castration-resistant prostate cancer (mCRPC) compared to a placebo with AA-P. The study will look at how long patients live without their cancer getting worse, using scans to measure this. There are two groups in the study: one includes all patients regardless of their DNA repair status, and the other includes patients with specific DNA repair issues.

Eligibility Criteria

Inclusion Criteria

  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 Criteria

  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

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