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Study on Apalutamide with Radiotherapy and Hormone Therapy for High-Risk Prostate Cancer Patients with Rising PSA After Surgery

Verified siteInvestigationalNo placebo

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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 high-risk biochemically-relapsed prostate cancer, which occurs when prostate cancer returns after surgery, indicated by rising PSA levels. The study is investigating the effects of a treatment combination that includes a new drug called apalutamide, which is designed to target and slow down the growth of prostate cancer. This drug will be used alongside radiotherapy and a type of hormone therapy known as an LHRH agonist, which helps to lower testosterone levels that can fuel cancer growth.

The purpose of the study is to evaluate the benefits of adding apalutamide to the existing treatment regimen for patients who have experienced a return of prostate cancer after surgery. Participants in the study will receive either the combination of apalutamide, radiotherapy, and hormone therapy or a placebo along with radiotherapy and hormone therapy. The study will monitor the participants over a period of time to assess how well the treatment works in preventing the cancer from progressing.

Throughout the study, participants will undergo regular check-ups and tests to track their health and the status of their cancer. The study aims to determine if the addition of apalutamide can improve the length of time patients remain free from cancer progression. The results will help to understand the potential benefits of this treatment combination for individuals with high-risk prostate cancer that has returned after surgery.

The research process

The trial runs in 6 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, the patient will be informed about the trial procedures and will provide written consent to participate.
The patient must meet specific health criteria, including adequate kidney and liver function, and must not have any signs of metastatic disease.
Step 2
Initial assessment
An initial assessment will be conducted to confirm eligibility, including a review of medical history and current health status.
The patient's prostate-specific antigen (PSA) levels will be measured to establish a baseline.
Step 3
Treatment phase
The patient will begin treatment with apalutamide, an androgen receptor inhibitor, taken orally as a film-coated tablet.
The dosage and frequency of apalutamide will be determined by the study protocol and monitored by the healthcare team.
In addition to apalutamide, the patient will receive a Luteinizing Hormone Releasing Hormone (LHRH) agonist to help manage hormone levels.
The patient will also undergo salvage radiotherapy (SRT) to target any remaining cancer cells.
Step 4
Monitoring and follow-up
Throughout the treatment phase, the patient will have regular follow-up visits to monitor health status and treatment effects.
PSA levels will be checked periodically to assess the response to treatment.
The patient will complete quality of life questionnaires to provide feedback on their well-being during the study.
Step 5
End of treatment evaluation
At the end of the treatment phase, a comprehensive evaluation will be conducted to assess the patient's response to the therapy.
The healthcare team will review all collected data, including PSA levels and any side effects experienced.
Step 6
Long-term follow-up
The patient will continue to be monitored for up to 10 years to evaluate long-term outcomes, including progression-free survival and overall survival.
Regular assessments will be conducted to check for any signs of cancer recurrence or progression.

Who can join the trial?

14 criteria

Patients must have signed a written informed consent form before any trial-specific procedures.
Must have adequate kidney function, which means a certain level of creatinine in the blood should be below a specific limit.
Must have adequate liver function, meaning certain liver-related blood tests should be within specific limits.
If patients have a heart condition called QTc prolongation, it should be less than 500 milliseconds. A heart specialist should assess the risks and benefits before starting treatment.
Patients must be willing and able to follow the study protocol, including attending treatments, visits, and examinations.
Patients must be part of the Social Security System.
Age must be between 18 and 80 years old.
Must have a confirmed diagnosis of prostate adenocarcinoma, treated initially with surgery to remove the prostate.
The tumor stage should be pT2, pT3, or pT4 (only if the bladder neck is involved).
Patients should not have signs of cancer spread to other parts of the body, but local or pelvic lymph node relapse is allowed.
Must have an ECOG performance status of 0 or 1, which means the patient is fully active or has some symptoms but can carry out light work.
PSA level, a marker in the blood, should be 0.2 ng/mL or higher at the time of randomization, with an increase over three consecutive tests at least one month apart.
There should be at least 3 months between the prostate surgery and the start of the study.
Must have high-risk features, such as a PSA level at relapse greater than 0.5 ng/mL, a Gleason score greater than 7, a tumor stage of pT3b, certain surgical margins, a PSA doubling time of 6 months or less, or pelvic lymph node relapse involving 5 or fewer lymph nodes.

Who cannot join the trial?

6 criteria

Patients who are not male cannot participate in the study.
Patients who do not have high-risk prostate cancer that has returned after surgery cannot participate.
Patients who have not had a radical prostatectomy, which is a surgery to remove the prostate gland, cannot participate.
Patients who are not experiencing a biochemical relapse, which means a rise in prostate-specific markers indicating cancer return, cannot participate.
Patients who are not in the specified age range cannot participate.
Patients who are part of a vulnerable population, meaning they need special protection, cannot participate.

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Verified sites

All sites with verified contact details – recruitment status may not be available; ask directly

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CHU De Martinique
Fort De France, France
Verified
Centr Georges Francois Leclerc
Dijon, France
Verified
Centre Hospitalier Departemental Vendee
La Roche sur Yon, France

Trial locations

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Investigated drugs

Apalutamide
is a medication used in this trial to help treat prostate cancer. It works by blocking the action of male hormones that can promote the growth of cancer cells. In this study, it is being tested to see if it can improve outcomes for patients who have experienced a return of prostate cancer after surgery.
LHRH Agonist
is another treatment used in the trial. This type of medication helps to lower the levels of male hormones in the body, which can slow down or stop the growth of prostate cancer cells. It is used in combination with other treatments to enhance their effectiveness.
Salvage Radiotherapy (SRT)
is a form of radiation treatment aimed at eliminating any remaining cancer cells after prostate surgery. In this trial, it is used alongside medications to see if it can help prevent the cancer from coming back or spreading.

Apalutamide

What is already known about the treatment

Apalutamide – This medication is administered orally and is used in combination with radiotherapy and a Luteinizing Hormone Releasing Hormone (LHRH) agonist. It is currently being studied in clinical trials for its effectiveness in treating high-risk prostate cancer that has returned after surgery. 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.

Investigated diseases

Prostate Adenocarcinoma – Prostate adenocarcinoma is a type of cancer that begins in the gland cells of the prostate, which is a small gland in men that produces seminal fluid. It is characterized by the uncontrolled growth of cells in the prostate gland. The disease may initially present with no symptoms, but as it progresses, it can lead to difficulties in urination, blood in the urine, or pelvic discomfort. In some cases, it may spread to nearby tissues or distant parts of the body, such as bones or lymph nodes. The progression of the disease can vary, with some cases remaining localized for many years, while others may advance more rapidly. Monitoring and management are crucial to understanding the disease's progression and impact on the patient's health.