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Updated May 2026 · ClinicalTrials.gov

RECRUITINGPhase 2INTERVENTIONAL

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)

Radiotherapy Combined With Fluzopanib and Abiraterone Acetate Tablets (II) Treatment for mCRPC (NCT06971211) is a Phase 2 interventional studying Metastatic Castration-resistant Prostate Cancer, sponsored by Jianbin Bi. RECRUITING as of the most recent ClinicalTrials.gov update. Talk to your doctor before contacting the trial site.

Important: This information is not medical advice. Talk to your doctor about whether a clinical trial is right for you.

About This Trial

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.

What Stage of Research Is This?

Phase 2 trials evaluate whether a treatment actually works against Metastatic Castration-resistant Prostate Cancer and continue monitoring side effects. Phase 2 enrolls larger groups (typically 100–300 patients) and produces the first real efficacy signal. A successful Phase 2 readout is what unlocks the much larger Phase 3 confirmatory trials needed for FDA approval.

This trial is currently recruiting participants. The sponsor has registered the study with ClinicalTrials.gov as actively enrolling, which means new applicants who meet the eligibility criteria can be considered for screening. Trial status can change between updates — confirm current recruiting status with the study contact before traveling for a screening visit.

With a target enrollment of 40 participants, this is a small study — typical of early-phase research, rare-disease trials, or pilot studies designed to generate preliminary signal before a larger study is launched.

Who May Be Eligible (Plain English)

Who May Qualify: 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): white blood cell count (ANC) at least 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 willing to sign a consent form form and expect good compliance with the research protocol Who Should NOT Join This Trial: 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 ...See full criteria on ClinicalTrials.gov Always talk to your doctor about whether this trial is right for you.

These are translations of the protocol\'s inclusion and exclusion criteria, simplified for patients and caregivers. The original clinical text appears below. Eligibility is ultimately confirmed by the trial site\'s screening process — this summary is a starting point for a conversation with your doctor, not a final determination.

Original Eligibility Criteria

View original clinical language
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

Treatments Being Tested

DRUG

Intensity-modulated radiation therapy (IMRT) in combination with fluzoparib, abiraterone acetate tablets (II), and prednisone.

Induction therapy, fluzoparib (150mg BID orally), abiraterone acetate tablets (II) (300mg QD orally), and prednisone (5mg BID orally). IMRT was administered as follows: For patients with low metastatic burden tumors: Prostate ± pelvic lymph node radiation + metastatic lesion radiation.For patients with non-low metastatic burden tumors: Prostate±pelvic lymph node radiation.IMRT dosage:Prostate: 70 Gy in 28 fractions (2.5 Gy/fraction, 5 fractions per week).Pelvic lymph nodes: 50.4 Gy in 28 fractions (1.8 Gy/fraction, 5 fractions per week).Fluzoparib and abiraterone acetate (II) were administered concurrently with radiotherapy. Maintenance treatment,patients received the same doses of fluzoparib,abiraterone acetate (II), and prednisone. Each treatment cycle lasted 28 days.

Locations (1)

Trial sites listed on ClinicalTrials.gov for this study. Site activation status can vary — confirm with the specific site before traveling for a screening visit.

The First Affiliated Hospital of China Medical University
Shenyang, Liaoning, China

How to Talk to Your Doctor About This Trial

Bring the printable summary of this trial — including the NCT ID (NCT06971211), the sponsor (Jianbin Bi), and the key eligibility criteria — to your next appointment. Your doctor can review the inclusion and exclusion criteria against your medical history, lab values, and current treatments to assess whether you are likely to qualify. They can also help you weigh whether trial participation makes sense alongside your existing care plan.

Useful questions to walk through together: What does the trial protocol require beyond standard care? How long is the active treatment phase, and how long is follow-up? Are there study visits at sites I can reach? Who pays for the trial-specific procedures, and who pays for standard-of-care portions? See our 25 questions to ask about clinical trials guide for a more complete checklist.

Authoritative Sources

The official record for this trial lives on ClinicalTrials.gov — the federal registry maintained by the National Library of Medicine at NIH. For background on how this trial fits into the FDA approval pathway, see the FDA drug approval process. For oncology-specific guidance for patients considering trials, the National Cancer Institute publishes patient-oriented overviews. International trial registries are aggregated by the WHO ICTRP.

Frequently Asked Questions

What is the NCT06971211 clinical trial studying?

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. The full protocol is registered on ClinicalTrials.gov and includes the primary outcome measures, eligibility criteria, and study endpoints.

Who can participate in NCT06971211?

Eligibility for this trial depends on the specific inclusion and exclusion criteria set by the sponsor. The plain-English summary above translates the most important criteria into accessible language; the official clinical text is preserved in the collapsible section underneath. Whether you fit any specific trial is a medical decision your doctor needs to confirm — bring the trial information to your treating physician for a full review against your medical history.

How do I contact the trial site for NCT06971211?

Contact information registered with ClinicalTrials.gov is shown in the sidebar of this page. Before reaching out, confirm with your treating physician that this trial is appropriate for your situation. The trial site will then walk you through the screening process to determine final eligibility.

Is participating in a clinical trial safe?

Clinical trials in the United States are regulated by the FDA and overseen by Institutional Review Boards (IRBs) that review the protocol for safety. Risk varies by trial — Phase 1 studies test new treatments in humans for the first time, while Phase 3 trials use treatments that have already passed earlier safety screening. The informed consent document for any specific trial details the known risks and what to expect. Discuss those risks with your physician before deciding whether to participate.

Where can I verify the data on this page?

Every detail on this page comes directly from the ClinicalTrials.gov API. Click "View on ClinicalTrials.gov" in the sidebar to see the official, unmodified record. The federal record is always authoritative; this page is a structured presentation with a plain-English eligibility translation. For background on how clinical trials are regulated, see the FDA drug approval process documentation.

How This Page Is Built

Every field on this page is pulled directly from the ClinicalTrials.gov API v2 — no estimates, no proxies. The plain-English eligibility translation is generated from the original protocol text and reviewed for fidelity to the underlying clinical criteria. The original clinical text remains visible in the collapsible section above so users and clinicians can verify the translation. Read the full methodology for the data pipeline and known limitations.

Source: ClinicalTrials.gov API v2 record for NCT06971211. Maintained by the National Library of Medicine at NIH. Public domain. Cite as: "TrialFinderData. NCT06971211. Data: ClinicalTrials.gov."

Medical disclaimer: This page is informational, not medical advice. Talk to your doctor about whether a clinical trial is right for you.

Last updated 2026-05-08 · Data from ClinicalTrials.gov.