This clinical trial is focused on studying treatments for high-risk localized or locally advanced prostate cancer. The study involves the use of a medication called JNJ-56021927, also known as apalutamide, which is taken as a film-coated tablet. The purpose of the study is to determine if combining apalutamide with a type of hormone therapy called a GnRH agonist can improve outcomes for patients receiving primary radiation therapy for prostate cancer.
Participants in the study will receive either the active medication or a placebo, which is a substance with no active drug, to compare the effects. The study will also involve the use of other treatments, such as androgen deprivation therapy, which is a common approach to lower male hormone levels that can fuel prostate cancer growth. The trial will monitor the participants over a period to see if the treatment helps in delaying the spread of cancer to other parts of the body, as assessed by imaging techniques like PSMA-PET scans.
The study is designed to be double-blind, meaning neither the participants nor the researchers will know who is receiving the active medication or the placebo, ensuring unbiased results. The trial will last for a specific period, and participants will be closely monitored for any changes in their condition and any side effects from the treatment. The goal is to gather information that could lead to better treatment options for those with high-risk prostate cancer.
1joining the study
Upon joining the study, eligibility is confirmed based on specific criteria such as age, planned radiation therapy, and prostate cancer diagnosis.
Participants must provide informed consent and demonstrate the ability to swallow study drug tablets.
2randomization
Participants are randomly assigned to receive either the study drug or a placebo. This process is double-blind, meaning neither the participant nor the researchers know which treatment is being administered.
3medication administration
Participants receive apalutamide in the form of a film-coated tablet, taken orally. The dosage and frequency are determined by the study protocol.
A GnRH agonist is also administered as part of the treatment regimen.
4primary radiation therapy
Participants undergo primary radiation therapy as part of their treatment for prostate cancer. This is a planned component of the study.
5monitoring and evaluation
Participants are monitored for the occurrence of metastasis using imaging techniques such as conventional imaging or PSMA-PET imaging.
The primary endpoint is the time from randomization to the first occurrence of distant metastasis or death from any cause.
6study completion
The study is estimated to conclude by August 2025. Participants will continue to be monitored until the study’s end date.
Who Can Join the Study?
Must be at least 18 years old.
Must be planning to receive primary radiation therapy for prostate cancer.
Must have a confirmed diagnosis of prostate cancer with specific conditions:
A Gleason Score of 8 or higher and a cancer stage of cT2c or higher.
Or a Gleason Score of 7, a PSA level of 20 or higher, and a cancer stage of cT2c or higher.
Must have a Charlson comorbidity index of 3 or less. This is a score that predicts the risk of death from other illnesses.
Must have an ECOG Performance Status of 0 or 1, which means being fully active or having some symptoms but being able to do light work.
Must have adequate organ function based on specific blood tests:
AST and ALT levels within normal limits. These are liver enzymes.
Total bilirubin within normal limits. This is a substance made by the liver.
Serum creatinine less than 1.5 mg/dL. This measures kidney function.
Platelets of at least 140,000/μL, which are cells that help with blood clotting.
Hemoglobin of at least 12.0 g/dL, which is a protein in red blood cells that carries oxygen.
If sexually active, must agree to use a condom and not donate sperm during the trial.
Must sign a written informed consent form, agreeing to participate in the study.
Must be able to swallow whole study drug tablets.
Who Cannot Join the Study?
Patients who are not male cannot participate in the study.
Patients who do not have high- or very-high risk, localized or locally advanced prostate cancer cannot participate.
Patients who are considered part of a vulnerable population cannot participate. A vulnerable population includes groups like children, pregnant women, or people who might not be able to make decisions for themselves.
Apalutamide is a medication used in this trial to treat prostate cancer. It works by blocking the effects of male hormones that can promote the growth of cancer cells. In this study, it is being tested to see if it can help improve outcomes for patients with high-risk prostate cancer who are also receiving radiation therapy.
GnRH Agonist is another treatment used in this trial. It helps to lower the levels of male hormones in the body, which can slow down or stop the growth of prostate cancer cells. This medication is used in combination with apalutamide to see if it can further improve the treatment results for patients undergoing radiation therapy for prostate cancer.
Prostate Cancer – Prostate cancer is a disease where cells in the prostate gland grow uncontrollably. It is often categorized by its risk level and stage, such as high-risk localized or locally advanced. In its localized form, the cancer is confined to the prostate, while locally advanced cancer has spread to nearby tissues. The progression of prostate cancer can vary, with some forms growing slowly and others more aggressively. Symptoms may include difficulty urinating, blood in urine, or pelvic discomfort, but early stages often present no symptoms. The disease’s progression is monitored through imaging and other diagnostic methods to assess the spread and impact on the body.
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