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NCT06971211RecruitingPhase 2

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

An Open, Single Arm, Multicenter Clinical Study on the First-line Treatment of Metastatic Castration Resistant Prostate Cancer With Radiotherapy Combined With Fuzuloparib and Abiraterone Acetate Tablets(Ⅱ)

Source: ClinicalTrials.gov · Last updated 14 May 2025 · Not updated for over 12 months - ask the site whether it is still open

Brief summary (registry, in English)

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.

Status (registry)
Recruiting
Phase (registry)
Phase 2
Study type
Interventional
Enrollment
40 (estimated)
First submitted
18 Apr 2025
Start date
27 Nov 2024
Primary completion date
30 Oct 2027
Lead sponsor
Jianbin Bi
NCT number
NCT06971211

What you commit to

  • Study type: Interventional · Phase 2
  • Planned participants: 40
  • From 27 Nov 2024 to the primary completion date, 30 Oct 2027
  • 1 site in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • Previously received any PARPi treatment for prostate cancer (including but not limited to Olaparib, Nilaparib, Terazopanib, Lucaparib, etc.)
  • Other clinical trial drug treatments and major surgeries received within the 4 weeks prior to randomization in this study
  • There are factors such as inability to swallow, chronic diarrhea and intestinal obstruction, or other factors that affect medication intake and absorption
  • Have a history of epilepsy or have experienced a disease that can trigger epileptic seizures within the 12 months prior to randomization (including a history of transient ischemic attacks, stroke, traumatic brain injury with consciousness disorders requiring hospitalization)
  • Patients with other malignant tumors within the past 3 years prior to randomization (excluding in situ cancer that has completely resolved and malignant tumors judged by researchers to have slow progression)

Other illness

  • Active heart disease within the first 6 months of randomization, including severe/unstable angina, myocardial infarction, symptomatic congestive heart failure (heart function class III or IV), and drug-induced ventricular arrhythmias
  • Individuals with active HBV and HCV infection (HBsAg positive and virus copy number ≥ 500 IU/mL, HCV antibody positive and HCV RNA above the detection limit of the analytical method)
  • Individuals with a known history of allergies to Fluzopanib and Abiraterone nanocrystals and their components

Lab values

  • Individuals with a history of congenital immunodeficiency or organ transplantation, or HIV positive subjects who meet one or more of the following criteria: Not receiving highly effective antiretroviral therapy; Change antiretroviral therapy within 6 months prior to the start of screening; • Undertaking antiretroviral therapy that may interfere with the investigational drug (please consult the sponsor before enrollment); CD4 count\<350/mm3 during screening; Opportunistic infections that meet the definition of acquired immunodeficiency syndrome occurred within the 12 months prior to the start of screening

Other

  • The researchers determined that participants with ejaculation ability and sexual activity were unwilling to take the contraceptive measures specified in the protocol during the entire study treatment period and within 3 months after the last dose

Who the study is looking for

  • Age ≥ 18 years old, male
  • ECOG score is 0 or 1
  • Untreated first-line metastatic castration resistant prostate cancer patients
  • Allow the use of a new endocrine drug treatment once during hormone sensitive stages
  • The organ function level must meet the following requirements (no blood transfusion or hematopoietic growth factor therapy received within 2 weeks before blood routine screening): ANC ≥ 1.5 × 109/L PLT≥100×109/L; • Hb≥90 g/L; • TBIL ≤ 1.5 × ULN (excluding subjects with Gilbert syndrome) • ALT and AST ≤ 2.5 × ULN; • Cr≤1.5×ULN; • LVEF≥50%; • QTcF≤450 ms。
  • If the partner is a subject with fertility, they should undergo surgical sterilization or agree to receive it during and at the end of the trial period
  • Sign a written informed consent form and expect good compliance with the research protocol

Age in the registry: 18 years to - · Sex: Male · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (1)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
The First Affiliated Hospital of China Medical University
Coordinator of this site? Confirm its status
ShenyangChinaRecruiting

This page is information, not medical advice. Discuss any trial with your doctor.