Combining radiotherapy with fluzopanib and abiraterone for advanced prostate cancer

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）

This study is testing whether combining radiation therapy with two medications, fluzopanib and abiraterone, can help men with advanced prostate cancer feel better and live longer.

Quick facts

• Phase: PHASE2
• Study type: Interventional
• Enrollment: 40 (estimated)
• Ages: 18 Years and up
• Sex: Male
• Sponsor: First Hospital of China Medical University (other)
• Drugs / interventions: Radiation, prednisone
• Locations: 1 site (Shenyang, Liaoning)
• Trial ID: NCT06971211 on ClinicalTrials.gov

What this trial studies

This open-label, single-arm, multicenter clinical trial aims to evaluate the efficacy, safety, and quality of life of combining radiotherapy with fluzopanib and abiraterone acetate as a first-line treatment for patients with metastatic castration-resistant prostate cancer (mCRPC). The study will enroll 40 eligible subjects who will undergo two phases of treatment: an induction phase with intensity-modulated radiation therapy (IMRT) and a maintenance phase with continued medication. The primary endpoint is the PSA response rate, defined as the proportion of patients achieving a ≥50% decrease in PSA from baseline. Secondary endpoints include radiographic progression-free survival and time to PSA progression.

Who should consider this trial

Good fit: Ideal candidates are untreated male patients aged 18 or older with metastatic castration-resistant prostate cancer and an ECOG score of 0 or 1.

Not a fit: Patients who have previously received any PARP inhibitor treatment for prostate cancer may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment approach could improve outcomes and quality of life for patients with advanced prostate cancer.

How similar studies have performed: While this approach is innovative, similar studies combining radiotherapy with targeted therapies have shown promise in other cancer types, suggesting potential for success.

Eligibility criteria

Inclusion Criteria:

1. Age ≥ 18 years old, male
2. ECOG score is 0 or 1
3. Untreated first-line metastatic castration resistant prostate cancer patients
4. Allow the use of a new endocrine drug treatment once during hormone sensitive stages
5. 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。
6. 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
7. Sign a written informed consent form and expect good compliance with the research protocol

Exclusion Criteria:

1. Previously received any PARPi treatment for prostate cancer (including but not limited to Olaparib, Nilaparib, Terazopanib, Lucaparib, etc.)
2. Other clinical trial drug treatments and major surgeries received within the 4 weeks prior to randomization in this study
3. There are factors such as inability to swallow, chronic diarrhea and intestinal obstruction, or other factors that affect medication intake and absorption
4. 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)
5. 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
6. 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)
7. Individuals with a known history of allergies to Fluzopanib and Abiraterone nanocrystals and their components
8. 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
9. 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)
10. 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

Where this trial is running

Shenyang, Liaoning

• The First Affiliated Hospital of China Medical University — Shenyang, Liaoning, China (RECRUITING)

Study contacts

• Study coordinator: Jianbin Bi, Doctor

Conditions: Metastatic Castration-resistant Prostate Cancer, prostate cancer, fuzuloparib, abiraterone acetate, Intensity modulated radiotherapy