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:

• Men aged 18 or older
• People who have been diagnosed with a specific high-grade prostate cancer (Gleason score of 8 or higher), confirmed by a biopsy showing cancer in at least 3 tissue samples, with at least one sample containing 8 mm or more of high-grade cancer — and the biopsy must be reviewed at MD Anderson Cancer Center
• People whose cancer has not spread to other parts of the body, as confirmed by bone scan and CT or MRI imaging taken within the past 60 days
• People whose cancer is localised or locally advanced and whose surgeon considers surgery to be possible, including removal of the prostate and nearby lymph nodes
• People who have not received any prior treatment for prostate cancer (a procedure called TURP is the one exception allowed)
• People with a general health status rated as fully active or able to carry out light work (ECOG performance score of 0 or 1)
• People whose blood counts and organ function meet minimum levels, including red blood cells, white blood cells, platelets, kidney function, and liver function (specific values will be checked by the trial site)
• People who are willing and able to attend clinic visits and follow all study procedures
• People who agree to use a condom during sexual activity while on the study drug and for 3 months after the last dose, and to avoid donating sperm during this time
• People who agree to provide a signed consent form and agree to participate in a separate laboratory study at MD Anderson Cancer Center (protocol PA13-0291)

Who may not be able to join:

• People who have previously received any hormone therapy for prostate cancer, such as anti-androgens, certain medications, or surgical removal of the testicles (note: 5-alpha reductase inhibitors are permitted)
• People currently taking part in another interventional clinical trial
• People taking high-dose corticosteroid medications (above the equivalent of 10 mg of prednisone per day) or other immune-suppressing drugs within the 14 days before starting treatment — topical, inhaled, nasal spray, or eye drop steroids are allowed
• People with a history of autoimmune disease (exceptions may apply for certain conditions such as vitiligo, resolved childhood eczema, or a well-managed thyroid condition — confirm with trial site)
• People with a known active infection requiring ongoing treatment, such as active hepatitis or a serious fungal infection; people with HIV may be eligible if their infection is well-controlled (confirm with trial site)
• People with a significant heart or cardiovascular condition, including a heart attack or unstable chest pain within the past 6 months, serious heart rhythm problems, blood clots, stroke within the past 6 months, advanced heart failure, or inflammation of the heart or its surrounding lining
• People with certain implants or medical devices, including artificial heart valves, artificial joints placed within the past 12 months, or a history of serious complications related to any implant that cannot be removed
• People who have had another cancer within the past 2 years (exceptions may apply for certain skin cancers or cancers fully in remission — confirm with trial site)
• People who have had major surgery within 14 days before the first dose of the study drug
• People who have had brain or nerve-related conditions such as encephalitis, meningitis, a significant neurodegenerative disease, or uncontrolled seizures in the year before starting the study
• People with a known history of serious lung inflammation (interstitial lung disease or non-infectious pneumonitis) in the past 5 years
• People who have received a live vaccine within 4 weeks of the planned start of treatment
• People who have had an organ transplant at any time, or a stem cell transplant within the past 12 weeks
• People whose overall medical, psychological, or social circumstances are considered by the trial investigators to make participation unsuitable

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