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Study of Niraparib, Abiraterone Acetate, and Prednisone for Patients with Metastatic 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 the treatment of metastatic prostate cancer, a type of cancer that has spread from the prostate to other parts of the body. The study is comparing the effectiveness of a combination of medications: niraparib, abiraterone acetate, and prednisone, against the use of abiraterone acetate and prednisone alone. Niraparib is a medication that may help stop cancer cells from repairing themselves, while abiraterone acetate works by reducing the levels of male hormones that can promote cancer growth. Prednisone is a steroid that can help reduce inflammation and support the effectiveness of other cancer treatments.

The purpose of this study is to evaluate how well the combination of niraparib with abiraterone acetate and prednisone works compared to abiraterone acetate and prednisone with a placebo. Participants in the study will be randomly assigned to receive either the combination treatment or the standard treatment with a placebo. The study will be conducted over a period of up to 52 weeks, during which participants will receive their assigned treatment and undergo regular assessments to monitor their health and the progression of the cancer.

Throughout the study, participants will have regular check-ups and imaging tests such as MRI or computed tomography (CT) scans to track the cancer's response to the treatment. The main goal is to determine if the combination of niraparib with abiraterone acetate and prednisone can improve the time patients live without the cancer getting worse, known as radiographic progression-free survival. This study aims to provide valuable information that could lead to improved treatment options for individuals with metastatic 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 the presence of metastatic prostate cancer and ensuring testosterone levels are at or below 50 nanograms per deciliter.

    Eligibility is further confirmed through imaging tests such as bone scans, CT, or MRI to document metastatic disease.

  2. Step 2

    Treatment group assignment

    Participants are randomly assigned to one of two groups. One group receives niraparib in combination with abiraterone acetate and prednisone, while the other group receives abiraterone acetate and prednisone with a placebo.

  3. Step 3

    Medication administration

    For those receiving niraparib, the dosage is 100 mg in capsule form, taken orally.

    The combination tablet of niraparib tosylate monohydrate and abiraterone acetate is administered as a film-coated tablet, with dosages of 79.90 mg (equivalent to 50 mg base) and 500 mg, respectively.

    Participants in both groups take abiraterone acetate as a 250 mg tablet and prednisone as a 5 mg tablet, both taken orally.

  4. Step 4

    Ongoing monitoring

    Throughout the study, regular monitoring is conducted to assess the effectiveness of the treatment. This includes tracking radiographic progression-free survival, which measures the time during and after treatment that the cancer does not grow.

    Participants continue to receive their assigned medications and attend scheduled follow-up visits for assessments and monitoring.

  5. Step 5

    Study completion

    The study is estimated to conclude by February 19, 2027. Upon completion, final assessments are conducted to evaluate the overall effectiveness of the treatment.

Who can join the trial?

7 criteria

  • The patient must have **metastatic prostate cancer**, which means the cancer has spread to other parts of the body.
  • The patient must have a change in the **HRR gene**, which will be identified by specific tests required by the study.
  • The patient must have **metastatic disease** confirmed by a positive bone scan or by finding metastatic lesions on a **CT** (computed tomography) or **MRI** (magnetic resonance imaging) scan.
  • The patient must have **castrate levels of testosterone**, which means very low levels of testosterone, less than or equal to 50 nanograms per deciliter (ng/dL). This can be achieved by using a **GnRHa** (gonadotropin-releasing hormone analog) or by having had a **bilateral orchiectomy** (surgical removal of both testicles).
  • If the patient has not had a surgical removal of the testicles, they must be able to continue using a **GnRHa** during the study.
  • The patient must have a score of 3 or less on a specific question about the worst pain they have experienced in the last 24 hours, as measured by the **brief pain inventory-short form (BPI-SF)**.
  • The patient must be male.

Who cannot join the trial?

3 criteria

  • Patients who do not have metastatic prostate cancer cannot participate. This means the cancer has spread from the prostate to other parts of the body.
  • Only male patients are eligible, so female patients cannot participate.
  • Patients who are considered part of a vulnerable population are not eligible. This term refers to groups of people who might be at a higher risk of harm or exploitation.
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Investigated drugs

  • Niraparib

    is a medication being studied for its potential to treat metastatic prostate cancer. It is being tested in combination with other medications to see if it can help slow down or stop the growth of cancer cells.

  • Abiraterone Acetate

    is a medication used to treat prostate cancer. It works by decreasing the production of certain hormones 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 cancer medications.

What is already known about the treatment

  • Niraparib

    Niraparib is administered orally and is currently being studied in clinical trials for its effectiveness in treating metastatic prostate cancer. It is a PARP inhibitor, which means it works by blocking an enzyme involved in repairing damaged DNA in cancer cells, leading to cell death. This medication is classified as an antineoplastic agent and is being evaluated for its potential to enhance the effects of other cancer treatments.

  • Abiraterone Acetate

    Abiraterone Acetate is taken orally and is an established treatment for metastatic prostate cancer. It works by inhibiting an enzyme that is crucial for the production of androgens, which are hormones that can promote the growth of prostate cancer cells. This medication is classified as an androgen biosynthesis inhibitor and is often used in combination with other treatments to improve outcomes for patients.

  • Prednisone

    Prednisone is administered orally and is commonly used in combination with other medications to treat metastatic prostate cancer. It is a corticosteroid that helps reduce inflammation and suppresses the immune response, which can help manage symptoms and improve the effectiveness of cancer treatments. Prednisone is classified as an anti-inflammatory and immunosuppressant agent.

Investigated diseases

Metastatic Prostate Cancer – This is a type of cancer that begins in the prostate gland and spreads to other parts of the body, such as bones or lymph nodes. The disease progresses as cancer cells break away from the original tumor and travel through the bloodstream or lymphatic system to form new tumors in other organs. Symptoms may include difficulty urinating, bone pain, and fatigue. As the cancer spreads, it can affect the function of the organs it invades, leading to more complex symptoms. The progression of the disease can vary greatly among individuals, with some experiencing rapid spread and others having a slower progression.
Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2023-503254-12-00Protocol code64091742PCR3001Estimated enrolment753 patientsSponsorJanssen Cilag International

sourced from the EU Clinical Trials Register and site verification

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