Phase 2 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 adenocarcinoma (a specific type of prostate cancer) confirmed by a tissue sample taken within the past 270 days.
• People whose prostate cancer is classified as "unfavorable intermediate risk," meaning it meets all of the following: at least one intermediate risk factor (a PSA blood test result between 10–20, a certain tumor stage found on exam or imaging, or a Gleason score of 7), plus at least one "unfavorable" feature such as more than one of those risk factors, a Gleason score of 4+3, or cancer found in 50% or more of the biopsy samples taken.
• People whose cancer staging tests show no spread to the bones or lymph nodes, based on scans done within the past 120 days.
• People aged 18 or older.
• People with a general health and activity level rated as fully active or able to carry out light physical activity (ECOG score of 0 or 1), assessed within the past 120 days.
• People with testosterone levels above 50 ng/dL (meaning hormone levels have not been suppressed), measured within the past 120 days.
• People whose recent blood tests (within 120 days) show acceptable levels of white blood cells, red blood cells, and platelets.
• People whose kidneys are functioning at an acceptable level, based on a calculation from recent blood tests (within 120 days).
• People whose liver function blood tests are within acceptable ranges, measured within the past 120 days.
• People living with HIV who are on effective treatment and have had an undetectable viral load within the past 6 months (HIV testing is not required to be considered).
• People with a history of hepatitis B who are on treatment and have an undetectable viral load, or who are immune to hepatitis B.
• People with a history of hepatitis C who have been successfully treated and cured, or who are currently on treatment with an undetectable viral load.
• People who are willing and able to provide written consent to participate before the study begins.

Who may not be able to join:

• People who have previously had surgery to remove the prostate, or any procedure intended to destroy prostate cancer tissue (such as cryotherapy or high-intensity focused ultrasound).
• People whose cancer has clearly spread to other parts of the body (metastatic disease).
• People who have had another type of cancer (other than certain common skin cancers) within the past 3 years.
• People who have previously received radiation treatment to the prostate or pelvis area that would overlap with the radiation fields used in this trial.
• People who have previously had both testicles surgically removed.
• People who have previously received hormone therapy for prostate cancer, including LHRH drugs or anti-androgen medications.
• People currently taking testosterone replacement therapy, unless it was stopped at least 1 year before joining (confirm with trial site regarding prior 5-alpha-reductase inhibitor use).
• People with serious, uncontrolled heart conditions, including unstable chest pain, irregular heart rhythms, or moderate-to-severe heart failure.
• People with any other health condition that, in the opinion of the trial doctor, would prevent safe participation.
• People with significant urinary blockage symptoms thought to be related to prostate cancer or an enlarged prostate.
• People who are unable to complete physical tests such as a treadmill exercise test, walking assessment, or grip strength test.
• People who are unable to have an MRI scan — for example, due to severe claustrophobia, certain metal implants, body size limitations, or an allergy to the contrast dye used in MRI.
• People with significant uncontrolled bowel conditions (such as Crohn's disease or ulcerative colitis) or uncontrolled metabolic conditions (such as diabetes or high cholesterol).
• People with active inflammatory or immune-related conditions currently being treated with steroids or other immune-suppressing medications.
• People who are unable to swallow pills.
• People whose cancer is considered high risk, which includes a Gleason score of 8–10, a PSA level above 20, or cancer that has clearly grown beyond the prostate based on physical exam or imaging.

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