This trial is examining the effectiveness of radiation therapy with or without apalutamide (Erleada) in the treatment of stage 3-4 prostate cancer. The main outcome to be measured will be survival without cancer worsening. This trial is recruiting in Canada and the United States.
Radiation therapy uses high energy x-ray to kill tumor cells and shrink tumors. Androgens can cause the growth of prostate cancer cells. Drugs, such as apalutamide, may lessen the amount of androgens made by the body. Giving radiation therapy and apalutamide may work better at treating prostate cancer than radiation alone.
This trial is examining the effectiveness of radiation therapy with or without apalutamide in the treatment of stage 3-4 prostate cancer. The main outcome to be measured will be survival without cancer worsening. This will be assessed for up to 6 years.
Who are they looking for?
This study requires 324 patients with stage 3-4 prostate cancer. Patients must have had prostate surgery within the last 10 years. Prior androgen deprivation (reducing) therapy is allowed if it was stopped at least 3 months before the trial. Patients must have adequate blood cell counts, testosterone and liver and kidney function tests. Contraception must be used during the study, and patients cannot donate sperm while on study drug, and for 3 months following the last dose of study drug.
Patients should not have another active cancer in the two years before starting this trial. Patients should not have heart failure, uncontrolled high blood pressure or unstable angina requiring treatment. Patients with a history of heart attack within 4 months or stroke within one year will not qualify for the trial. Patients must not have a history of radiotherapy to the prostate area, a history of seizures, or serious digestive system problems. Patients must not have an active infection including HIV or viral hepatitis.
How will it work
There will be two groups in this study. One group will receive radiation therapy and a placebo. The second group of patients will receive radiation therapy and apalutamide. Treatment will last up to 6 months. After completing the treatment, patients are followed up every 3 months for 2 years, then every 6 months for 3 years, and yearly for up to 6 years.