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Study of Fuzuloparib, Abiraterone Acetate, and Prednisone for First-Line Treatment in Patients with Metastatic Castration-Resistant Prostate Cancer

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What is this trial about?

A plain-language summary of the goals, design and what participants do

This clinical trial is focused on studying a type of prostate cancer known as Metastatic Castration-Resistant Prostate Cancer (mCRPC). This is a form of prostate cancer that has spread to other parts of the body and continues to grow even when the amount of testosterone in the body is reduced to very low levels. The study is investigating the effectiveness of a new treatment combination that includes the drug Fuzuloparib, along with Abiraterone Acetate and Prednisone (referred to as AA-P). Fuzuloparib is being tested to see if it can improve outcomes when added to the standard treatment of AA-P.

The purpose of the study is to determine if the combination of Fuzuloparib with AA-P is more effective than a placebo combined with AA-P as a first-line treatment for patients with mCRPC. Participants in the study will be randomly assigned to receive either the Fuzuloparib combination or the placebo combination. The study is designed to be "double-blind," meaning neither the participants nor the researchers will know who is receiving the actual treatment or the placebo, to ensure unbiased results.

Throughout the study, participants will take the medications orally, as they are in the form of tablets or capsules. The study will monitor the progression of the cancer and assess the overall health and survival of the participants. The trial aims to provide valuable information on whether adding Fuzuloparib to the existing treatment can offer better outcomes for patients with this challenging form of prostate cancer.

The research process

The trial runs in 5 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Initial assessment

    Upon joining the study, an initial assessment is conducted to confirm eligibility. This includes verifying age, organ function, and disease progression.

    Blood and tumor tissue samples may be collected to determine specific genetic markers.

  2. Step 2

    Randomization

    Participants are randomly assigned to one of two groups: one receiving the study medication fuzuloparib combined with abiraterone acetate and prednisone, and the other receiving a placebo combined with the same medications.

    This process is double-blind, meaning neither the participant nor the study team knows which group the participant is in.

  3. Step 3

    Medication administration

    Participants take abiraterone acetate as a 500 mg film-coated tablet orally once daily.

    Participants take prednisone as a 5 mg tablet orally twice daily.

    Participants in the study medication group take fuzuloparib orally, while those in the placebo group take a placebo capsule.

  4. Step 4

    Ongoing monitoring

    Regular monitoring is conducted to assess the effectiveness and safety of the treatment. This includes imaging tests and blood tests.

    Participants are evaluated for disease progression and any side effects from the medications.

  5. Step 5

    End of treatment

    The study treatment continues until disease progression, unacceptable side effects, or the participant decides to withdraw.

    After the treatment ends, follow-up assessments are conducted to monitor the participant's health and gather additional data.

Who can join the trial?

12 criteria

  • Must be at least 18 years old.
  • Organs must be working well, and no blood transfusion or special blood treatments should have been done within 2 weeks before the blood test.
  • If you can ejaculate and are sexually active, you must agree to use effective birth control and not donate sperm from the first dose until 3 months after the last dose of the study treatment.
  • Must join the clinical trial voluntarily, understand it, and have signed the informed consent form.
  • Must have an ECOG performance status score of 0 to 1, which means you are fully active or have some symptoms but can still do light work.
  • Expected to live for at least 6 more months.
  • Must have prostate adenocarcinoma, a type of prostate cancer, confirmed by tests, with no signs of other specific cancer types.
  • Must have cancer that has spread to other parts of the body, shown by imaging tests.
  • The prostate cancer must have gotten worse while on treatment to lower male hormones.
  • Must be on continuous treatment with a drug that lowers male hormones or have had surgery to remove both testicles. If you haven't had the surgery, you must plan to keep taking the hormone-lowering drug before and during the study.
  • Testosterone levels must be at or below the castration level, which is 50 ng/dL or 1.73 nmol/L, during screening.
  • Must provide blood and tumor tissue samples during screening to check for DRD status. If you are in Cohort 2, you must be DRD positive, meaning you have a specific genetic feature related to DNA repair.

Who cannot join the trial?

3 criteria

  • Patients who do not have metastatic castration-resistant prostate cancer cannot participate. This is a type of prostate cancer that has spread to other parts of the body and does not respond to treatments that lower testosterone.
  • Only male patients are eligible for this study.
  • Patients who are part of a vulnerable population are not eligible. This means groups of people who might need special protection, like those who cannot make decisions for themselves.
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Investigated drugs

  • Fuzuloparib

    is a medication being studied for its potential to treat metastatic castration-resistant prostate cancer. It is being tested to see if it can help slow down the progression of the disease when used in combination with other treatments.

  • Abiraterone Acetate

    is a medication used to treat prostate cancer. It works by decreasing the production of certain hormones in the body that can promote the growth of cancer cells.

  • Prednisone

    is a type of steroid that is often used in combination with other cancer treatments. It helps reduce inflammation and can improve the effectiveness of other medications used to treat cancer.

What is already known about the treatment

  • Fuzuloparib

    This medication is administered orally and is currently being studied in clinical trials for its effectiveness in treating metastatic castration-resistant prostate cancer. It is being evaluated in combination with Abiraterone Acetate and Prednisone as a first-line treatment. Fuzuloparib works by inhibiting a specific enzyme involved in DNA repair, which can help prevent cancer cells from repairing themselves, leading to their death. It is classified as a PARP inhibitor, a type of targeted cancer therapy.

  • Abiraterone Acetate

    This medication is taken orally and is widely used in the treatment of prostate cancer, particularly in advanced stages. It is combined with Prednisone to enhance its effectiveness. Abiraterone Acetate works by blocking the production of androgens, which are hormones that can promote the growth of prostate cancer cells. It is classified as an androgen biosynthesis inhibitor.

  • Prednisone

    This medication is administered orally and is commonly used in combination with other drugs to treat various conditions, including cancer. In the context of prostate cancer, it helps reduce inflammation and manage side effects associated with cancer treatment. Prednisone is a corticosteroid, which means it mimics the effects of hormones produced by the adrenal glands.

Investigated diseases

Metastatic Castration-Resistant Prostate Cancer – This is a type of prostate cancer that continues to grow and spread to other parts of the body despite treatments that lower testosterone levels. It is characterized by cancer cells that have adapted to survive in a low-testosterone environment. The disease often progresses with the cancer spreading to bones, lymph nodes, or other organs. Patients may experience symptoms such as bone pain, urinary issues, or fatigue as the cancer advances. The progression of the disease can vary, with some individuals experiencing rapid changes while others may have a slower progression.
Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2023-509396-16-00Protocol codeSHR3162-III-305Estimated enrolment804 patientsSponsorJiangsu Hengrui Pharmaceuticals Co. Ltd.

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