Study on ONCT-534 for Treating Advanced Prostate Cancer

Inclusion Criteria

• Men aged 18 or older.
• Diagnosed with advanced prostate cancer that has spread and is resistant to hormone therapy.
• Cancer must have returned or not responded after at least one hormone therapy.
• Must have at least one tumor that can be measured by scans or tests.
• Must be in good general health with a life expectancy of at least 6 months.
• Must agree to continue hormone therapy or have had surgery to remove the testicles.
• Must have stopped other cancer treatments at least 2 weeks before starting the study.
• Must have a PSA level of 10 ng/mL or higher, or 2 ng/mL with a 50% increase from the lowest level on previous therapy.
• Must have low testosterone levels.
• Must have good kidney, liver, and lung function.
• Must agree to use effective birth control during the study and for 3 months after.

Exclusion Criteria

• Have a type of prostate cancer with small cell or neuroendocrine features.
• Have cancer that has spread to the brain or spinal cord.
• Are receiving other cancer treatments, except for ongoing hormone therapy.
• Are taking certain medications that affect liver enzymes.
• Have had major surgery within 30 days before starting the study.
• Have untreated bone fractures or risk of fractures.
• Have spinal cord compression.
• Have a history of seizures.
• Have active infections like HIV, hepatitis B, or hepatitis C.
• Have other serious illnesses that could interfere with the study.
• Have abnormal heart rhythms or a history of certain heart conditions.
• Have had a fever or infection requiring antibiotics within a week before starting the study.
• Have another significant cancer that could affect study results.
• Are unable to follow the study protocol or attend follow-up visits.
• Have any condition that the study doctor believes could affect participation.