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Study on the Effectiveness of Apalutamide in Men with 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 condition known as Castration-Resistant Prostate Cancer, which is a type of prostate cancer that does not respond to treatments that lower testosterone. The study is testing a medication called Apalutamide, also known by its code name JNJ-56021927, to see if it can help men with this type of cancer. The trial will compare the effects of Apalutamide to a placebo, which is a substance with no active medication, to determine if Apalutamide can improve the time patients live without their cancer spreading, known as metastasis-free survival.

Participants in the study will receive either Apalutamide or a placebo, along with standard treatments such as Androgen Deprivation Therapy, which is a treatment that reduces male hormones in the body. Some participants may also receive other medications like ZYTIGA (abiraterone acetate) and PREDNISONE, which are used to manage prostate cancer. The study will last for a period of up to 48 months, during which participants will take the study medication orally in the form of film-coated tablets.

The purpose of this study is to evaluate the safety and effectiveness of Apalutamide in delaying the spread of prostate cancer in men who are at high risk of developing metastases. The trial aims to provide valuable information on whether Apalutamide can offer a better outcome for patients with castration-resistant prostate cancer compared to those who do not receive the active medication. Participants will be monitored regularly to assess their health and the progression of their cancer throughout the study period.

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

    Joining the study

    Upon joining the study, participation is confirmed through a signed and dated informed consent document. This indicates understanding of all pertinent aspects of the trial.

  2. Step 2

    Randomization

    Participants are randomly assigned to receive either the study drug Apalutamide or a placebo. This process is double-blind, meaning neither the participant nor the researchers know which treatment is being administered.

  3. Step 3

    Treatment administration

    The study drug Apalutamide is administered orally in the form of film-coated tablets. The dosage and frequency are determined by the study protocol.

    Participants may also receive ZYTIGA (abiraterone acetate) and PREDNISONE as part of the treatment regimen. ZYTIGA is available in 500 mg and 250 mg tablets, and PREDNISONE is administered orally.

  4. Step 4

    Monitoring and assessments

    Regular visits are scheduled to monitor health status, treatment effects, and disease progression. This includes laboratory tests, radiographic assessments, and completion of patient-reported outcomes questionnaires.

  5. Step 5

    Follow-up

    Long-term follow-up visits are conducted to assess the primary endpoint of Metastasis-Free Survival (MFS) and secondary endpoints such as time to metastasis, progression-free survival, and overall survival.

Who can join the trial?

12 criteria

  • Must have a confirmed diagnosis of prostate cancer that is resistant to castration, which means the cancer continues to grow even when testosterone levels are low.
  • Must be at high risk for the cancer spreading, shown by a PSA doubling time (PSADT) of 10 months or less. PSA is a protein made by the prostate, and its levels are used to monitor prostate cancer.
  • Must be 18 years of age or older.
  • Must have a performance status of 0 or 1 on the Eastern Cooperative Oncology Group (ECOG) scale, which means the patient is fully active or has some symptoms but does not need bed rest.
  • Must have testosterone levels below 50 ng/dL, achieved either through surgery or medication. If using medication, it must have been started at least 4 weeks before joining the study and continued throughout the study.
  • If receiving treatment to prevent bone loss, such as certain medications for osteoporosis, the patient must have been on a stable dose for at least 4 weeks before joining the study.
  • If previously treated with first-generation anti-androgens (medications that block male hormones), there must be a 4-week break before joining the study, and the cancer must still be progressing.
  • Must have stopped using certain medications, like 5-alpha reductase inhibitors or estrogens, and any other cancer treatments, at least 4 weeks before joining the study.
  • Must have recovered from any side effects of previous treatments or surgeries to a mild level or back to normal before joining the study.
  • Must have adequate organ function, which includes specific levels of liver enzymes, bilirubin, creatinine, neutrophils, platelets, and hemoglobin.
  • Must have signed a consent form indicating understanding of the trial details.
  • Must be willing and able to follow the study schedule, take the study medication, complete questionnaires, and attend follow-up visits.

Who cannot join the trial?

4 criteria

  • Patients who do not have **Castration-Resistant Prostate Cancer** cannot participate. This is a type of prostate cancer that continues to grow even when the amount of male hormones in the body is reduced to very low levels.
  • Only men can participate in this study. Women are not eligible.
  • Participants must be within a specific age range, typically adults and older adults.
  • Individuals who are considered part of a vulnerable population, such as those unable to give informed consent, are not eligible.
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Investigated drugs

Apalutamide is a medication used in the treatment of prostate cancer. It works by blocking the action of male hormones that can promote the growth of cancer cells. In this clinical trial, Apalutamide is being tested to see if it can help men with a specific type of prostate cancer, known as non-metastatic castration-resistant prostate cancer, live longer without the cancer spreading.

What is already known about the treatment

Apalutamide – Apalutamide is administered orally in tablet form. It is currently being studied in clinical trials for its effectiveness in treating non-metastatic castration-resistant prostate cancer (NM-CRPC). The main therapeutic indication for Apalutamide is to improve metastasis-free survival in men with high-risk NM-CRPC. At the molecular level, Apalutamide works by inhibiting the action of androgens, which are male hormones that can promote the growth of prostate cancer cells. It is classified as an androgen receptor inhibitor, which helps to slow down or stop the progression of prostate cancer.

Investigated diseases

Castration-Resistant Prostate Cancer – This is a type of prostate cancer that continues to grow even when the amount of testosterone in the body is reduced to very low levels. It typically occurs after treatments that lower testosterone, such as surgery or medication, have been used. The disease is characterized by the cancer's ability to progress despite the suppression of male hormones that usually fuel its growth. Over time, the cancer may spread to other parts of the body, such as bones or lymph nodes. Symptoms can include difficulty urinating, pain in the back or pelvis, and fatigue. The progression of the disease can vary, with some individuals experiencing a slow increase in symptoms, while others may notice more rapid changes.
Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2023-509221-47-00Protocol codeARN-509-003Estimated enrolment74 patientsSponsorAragon Pharmaceuticals Inc.

sourced from the EU Clinical Trials Register and site verification

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