Supraphysiologic Testosterone Priming Induces Darolutamide Extended Response

This study is testing whether giving men with advanced prostate cancer very high doses of testosterone (called bipolar androgen therapy or BAT) followed by a prostate cancer hormone-blocking drug (darolutamide) can improve treatment outcomes. The idea is that flooding cancer cells with testosterone first may make them more vulnerable to the hormone-blocking drug afterward. **You may be eligible if...** - You are 18 or older and have confirmed prostate cancer that has spread to other areas (metastatic) - Your PSA level is 1.0 ng/ml or higher - You have not previously received hormone-lowering therapy (ADT) for your current disease, except as part of radiation treatment completed more than 1 year ago - You have not previously received certain hormone-blocking prostate cancer drugs (abiraterone, enzalutamide, or darolutamide) for metastatic disease - Your PSA levels are rising **You may NOT be eligible if...** - You have previously received chemotherapy for prostate cancer - You have previously received certain nuclear medicine treatments (Pluvicto/lutetium) or experimental AR-targeted drugs - You have femoral or spinal bone metastases that pose fracture or spinal cord risk from testosterone exposure - You have very high blood count (hematocrit above 51%), severe sleep apnea, or uncontrolled heart failure - You are allergic to sesame or cottonseed oil - You had a heart attack within the past 5 years or have severe heart failure (Class III–IV) Talk to your doctor to see if this trial is right for you.