Phase 3 Prostate Cancer Trial, Recruiting

Written by an AI model from ClinicalTrials.gov eligibility criteria and checked on a sample basis. Please confirm against the original criteria.

Who might be able to join this trial:

• People who have been diagnosed with prostate cancer confirmed through a tissue sample (biopsy or surgical specimen).
• People whose PSA level is 0.1 or higher after having their prostate surgically removed.
• People whose treating doctor has determined them to be a suitable candidate for salvage radiation therapy and hormone therapy (to lower testosterone).
• People who are older than 18 years of age at the time of signing the consent form.
• People who are reasonably active and able to care for themselves, based on a standard medical scoring scale (confirm with trial site).
• People whose blood, kidney, and liver test results fall within acceptable ranges, based on lab tests done within 90 days of joining the trial (confirm with trial site for specific values).
• People who are able to understand and follow all study procedures for the full duration of the trial, as assessed by the trial team.
• People who can understand English or Spanish, since the main outcome measure is a questionnaire available only in those two languages.
• People who are willing and able to sign a written consent form before joining the trial.

Who may not be able to join:

• People who have received testosterone-lowering treatment (such as hormone injections or blockers) after their prostate surgery, unless their testosterone levels have since recovered to above 190 ng/dL.
• People who received testosterone-lowering treatment before their prostate surgery, if a specific risk assessment tool called the ArteraAI Prostate Test is needed to determine their treatment group (this applies to people with a PSA of 0.5 or lower and no sign of cancer in the lymph nodes).
• People who have confirmed cancer spread outside the pelvis or to the bones, based on standard imaging scans.
• People who have a history of seizures, or a condition that may increase the risk of seizures — such as a stroke within the past year, a brain blood vessel abnormality, or certain benign brain tumours that may need surgery or radiation.
• People who have had serious heart or blood vessel events in the 6 months before joining — such as a heart attack, severe chest pain, heart failure, a blood clot in the lungs, a stroke, or a significant irregular heartbeat.
• People who currently have uncontrolled high blood pressure (consistently above 160/100).
• People who currently have a digestive condition that affects how the body absorbs medications.
• People who currently have an active infection such as HIV or viral hepatitis.
• People who are taking medications known to lower the seizure threshold would need to stop or switch those medications at least 4 weeks before starting treatment, if they are assigned to a treatment arm that includes a drug called apalutamide (confirm with trial site).
• People whose other cancer history or its treatment could interfere with the safety or results of this trial (confirm with trial site).

Important: Always verify eligibility with the trial site directly before applying.