Phase
Condition
Prostate Cancer, Early, Recurrent
Prostate Disorders
Urologic Cancer
Treatment
Intensity-modulated radiation therapy (IMRT) in combination with fluzoparib, abiraterone acetate tablets (II), and prednisone.
Clinical Study ID
Ages > 18 Male
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
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 transfusionor hematopoietic growth factor therapy received within 2 weeks before blood routinescreening): 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 surgicalsterilization 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 researchprotocol
Exclusion
Exclusion Criteria:
Previously received any PARPi treatment for prostate cancer (including but notlimited to Olaparib, Nilaparib, Terazopanib, Lucaparib, etc.)
Other clinical trial drug treatments and major surgeries received within the 4 weeksprior to randomization in this study
There are factors such as inability to swallow, chronic diarrhea and intestinalobstruction, or other factors that affect medication intake and absorption
Have a history of epilepsy or have experienced a disease that can trigger epilepticseizures within the 12 months prior to randomization (including a history oftransient ischemic attacks, stroke, traumatic brain injury with consciousnessdisorders requiring hospitalization)
Active heart disease within the first 6 months of randomization, includingsevere/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 theanalytical method)
Individuals with a known history of allergies to Fluzopanib and Abirateronenanocrystals and their components
Individuals with a history of congenital immunodeficiency or organ transplantation,or HIV positive subjects who meet one or more of the following criteria: Notreceiving highly effective antiretroviral therapy; Change antiretroviral therapywithin 6 months prior to the start of screening; • Undertaking antiretroviraltherapy that may interfere with the investigational drug (please consult the sponsorbefore enrollment); CD4 count<350/mm3 during screening; Opportunistic infectionsthat meet the definition of acquired immunodeficiency syndrome occurred within the 12 months prior to the start of screening
Patients with other malignant tumors within the past 3 years prior to randomization (excluding in situ cancer that has completely resolved and malignant tumors judgedby researchers to have slow progression)
The researchers determined that participants with ejaculation ability and sexualactivity were unwilling to take the contraceptive measures specified in the protocolduring the entire study treatment period and within 3 months after the last dose
Study Design
Study Description
Connect with a study center
The First Affiliated Hospital of China Medical University
Shenyang, Liaoning 110001
ChinaActive - Recruiting

Not the study for you?
Let us help you find the best match. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.