Actively Recruiting

Phase 2
Age: 18Years +
MALE
NCT06971211

Radiotherapy Combined With Fluzopanib and Abiraterone Acetate Tablets (II) Treatment for mCRPC

Led by Jianbin Bi · Updated on 2025-05-14

40

Participants Needed

1

Research Sites

178 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

This study is an open label, single arm, multicenter clinical trial. The aim of this study is to evaluate the efficacy, safety, and quality of life of radiotherapy combined with Fuzuloparib and Abiraterone Acetate Tablets（Ⅱ） as first-line treatment for castration resistant prostate cancer patients. The study aims to enroll 40 eligible subjects with PSA response rate (PSA 50) as the primary endpoint.

CONDITIONS

Official Title

Radiotherapy Combined With Fluzopanib and Abiraterone Acetate Tablets (II) Treatment for mCRPC

Who Can Participate

Age: 18Years +
MALE

Eligibility Criteria

Eligible

You may qualify if you...

  • Male aged 18 years or older
  • ECOG performance status 0 or 1
  • Untreated first-line metastatic castration-resistant prostate cancer
  • Allowed one new endocrine drug treatment during hormone sensitive stage
  • Adequate organ function: ANC ≥ 1.5 × 10^9/L, platelets ≥ 100 × 10^9/L, hemoglobin ≥ 90 g/L, total bilirubin ≤ 1.5 × ULN (excluding Gilbert syndrome), ALT and AST ≤ 2.5 × ULN, creatinine ≤ 1.5 × ULN, left ventricular ejection fraction ≥ 50%, QTcF ≤ 450 ms
  • If partner is fertile, must undergo or agree to surgical sterilization during and after trial
  • Signed informed consent and expected good protocol compliance
Not Eligible

You will not qualify if you...

  • Previous treatment with any PARP inhibitor for prostate cancer
  • Use of other clinical trial drugs or major surgery within 4 weeks before study
  • Difficulty swallowing, chronic diarrhea, intestinal obstruction, or other issues affecting medication absorption
  • History of epilepsy or seizure-triggering conditions in past 12 months, including transient ischemic attacks, stroke, traumatic brain injury with consciousness disturbance
  • Active heart disease within 6 months, including severe/unstable angina, myocardial infarction, symptomatic congestive heart failure (class III or IV), drug-induced ventricular arrhythmias
  • Active hepatitis B or C infection with specified viral load
  • Known allergies to fluzopanib, abiraterone nanocrystals, or their components
  • History of congenital immunodeficiency, organ transplantation, or HIV positive with specific conditions
  • Other malignant tumors within past 3 years (excluding resolved in situ cancers or slow progressing tumors)
  • Unwillingness to use specified contraceptive measures during study and 3 months after last dose

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

The First Affiliated Hospital of China Medical University

Shenyang, Liaoning, China, 110001

Actively Recruiting

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Research Team

J

Jianbin Bi, Doctor

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NA

Model

SINGLE_GROUP

Primary Purpose

TREATMENT

Number of Arms

1

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