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Study on the Effectiveness and Safety of Apalutamide, Abiraterone Acetate, and Prednisone for 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 continues to grow and spread even when the amount of male hormones in the body is reduced to very low levels. The study is investigating the effectiveness and safety of a treatment combination that includes the medication JNJ-56021927, also known as apalutamide, in combination with abiraterone acetate and prednisone. These medications are being compared to the use of abiraterone acetate and prednisone alone.

The purpose of the study is to see how well the combination of these medications works in slowing down the progression of the cancer when compared to the standard treatment. Participants in the study will be randomly assigned to receive either the combination treatment or the standard treatment. The study will be conducted in a way that neither the participants nor the researchers will know which treatment each participant is receiving, which is known as a double-blind study. Some participants may receive a placebo instead of the active medication to help compare the effects.

Throughout the study, participants will take the medications in the form of tablets by mouth. The study will last for a period of up to 48 months, during which time participants will have regular check-ups and tests to monitor their health and the progression of the cancer. The main goal is to determine how long the cancer can be controlled without it getting worse, which is referred to as radiographic progression-free survival. Other aspects being studied include overall survival, the time until the need for pain medication, and the time until chemotherapy might be needed.

The research process

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

Step 1
Joining the study
Upon joining the study, participation is confirmed through random assignment to one of two groups. One group receives a combination of apalutamide, abiraterone acetate, and prednisone, while the other group receives a placebo with abiraterone acetate and prednisone.
Step 2
Medication administration
If assigned to the apalutamide group, take apalutamide as a film-coated tablet orally. The dosage and frequency are determined by the study protocol.
Take abiraterone acetate as a 250 mg tablet orally. The dosage and frequency are determined by the study protocol.
Take prednisone as a 5 mg tablet orally. The dosage and frequency are determined by the study protocol.
Step 3
Monitoring and assessments
Regular monitoring through imaging tests such as bone scans, CT scans, or MRI scans is conducted to assess the progression of the disease.
Blood tests are performed to measure prostate-specific antigen (PSA) levels and other relevant markers.
Step 4
Evaluation of progression
The primary goal is to evaluate radiographic progression-free survival (rPFS), which measures the time during which the cancer does not worsen based on imaging results.
Secondary evaluations include overall survival, time to chronic opioid use, time to initiation of cytotoxic chemotherapy, and time to pain progression.
Step 5
Completion of the study
The study is estimated to conclude by December 31, 2026. Participation continues until the study's end or until specific criteria for discontinuation are met.

Who can join the trial?

6 criteria

The patient must be a man who is at least 18 years old.
The patient must have a type of prostate cancer called adenocarcinoma.
The cancer must have spread to other parts of the body, which is known as metastatic disease. This can be shown by specific scans like a bone scan, CT scan, or MRI. If the cancer has only spread to lymph nodes, the affected lymph node must be at least 2 centimeters in size.
The patient must have castration-resistant prostate cancer, which means the cancer continues to grow even when the male hormone levels are low. This is shown by three increases in a blood test called PSA (prostate-specific antigen), with the last test showing a level of at least 2 nanograms per milliliter.
If the patient has taken certain medications called first-generation anti-androgens (like bicalutamide, flutamide, or nilutamide), they must stop taking them for at least 6 weeks before joining the study. The cancer must still be growing after stopping these medications, shown by an increase in PSA levels.
The cancer must be getting worse, shown by an increase in PSA levels, changes in soft tissues seen in scans, or changes in bones seen in scans, according to specific guidelines used in prostate cancer studies.

Who cannot join the trial?

5 criteria

Patients who have already received chemotherapy for their prostate cancer cannot participate.
Only male patients are eligible, so female patients cannot participate.
Patients with other serious health conditions that might interfere with the study cannot participate.
Patients who are unable to follow the study procedures or take the study medications as required cannot participate.
Patients who are part of a vulnerable population, meaning they might not be able to give informed consent or understand the study, cannot participate.

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Verified sites

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Amsterdam UMC
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Amsterdam, The Netherlands
Erasmus Universitair Medisch Centrum Rotterdam (Erasmus MC)
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Rotterdam, The Netherlands
Stichting Radboud University Medical Center
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Nijmegen, The Netherlands

Trial locations

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Investigated drugs

JNJ-56021927
This is an investigational medication being studied for its potential to treat metastatic castration-resistant prostate cancer (mCRPC). 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
This medication is used to treat prostate cancer by lowering the levels of certain hormones in the body that can promote the growth of cancer cells. It is often used in combination with other medications to enhance its effectiveness.
Prednisone
This is a type of steroid that is used to reduce inflammation and suppress the immune system. In the context of prostate cancer treatment, it is used alongside other medications to help manage side effects and improve treatment outcomes.
Prednisolone
Similar to prednisone, prednisolone is a steroid used to reduce inflammation and suppress the immune system. It is used in combination with other cancer treatments to help manage symptoms and improve the effectiveness of the therapy.

What is already known about the treatment

Apalutamide
This medication is administered orally and is currently being studied in clinical trials for its effectiveness in treating metastatic castration-resistant prostate cancer (mCRPC). It is often used in combination with abiraterone acetate and prednisone. Apalutamide works by blocking 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 and is being evaluated for its ability to improve radiographic progression-free survival in patients who have not undergone chemotherapy.
Abiraterone Acetate
This medication is taken orally and is used in combination with prednisone to treat metastatic castration-resistant prostate cancer (mCRPC). It is well-established in medical literature and works by inhibiting an enzyme called CYP17, which is involved in the production of androgens. By reducing androgen levels, abiraterone acetate helps slow the growth of prostate cancer cells. It is classified as a CYP17 inhibitor and is part of ongoing research to assess its effectiveness in combination therapies.
Prednisone
This medication is administered orally and is commonly used alongside other treatments for metastatic castration-resistant prostate cancer (mCRPC). Prednisone is a corticosteroid that helps reduce inflammation and suppresses the immune system, which can be beneficial in managing cancer-related symptoms. It is well-documented in medical literature and is often used to enhance the effectiveness of other cancer treatments. Prednisone is classified as a glucocorticoid and is being studied for its role in combination therapies to improve patient outcomes.

Investigated diseases

Metastatic Castration-Resistant Prostate Cancer (mCRPC) – 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 the cancer's ability to resist hormonal therapy, which is typically used to slow its progression. The disease often spreads to bones and lymph nodes, leading to symptoms such as pain and fatigue. Over time, the cancer may cause more severe symptoms as it affects additional organs. The progression of mCRPC can vary, but it generally involves increasing resistance to standard treatments.