Study on Bipolar Androgen Therapy and Radium-223 for Advanced Prostate Cancer

Inclusion Criteria

• Diagnosed with prostate cancer that is mostly adenocarcinoma.
• Cancer has spread to the bones, shown by a bone scan.
• Prostate cancer that continues to grow despite low testosterone levels due to hormone therapy or surgery.
• Rising PSA levels or new bone lesions indicating cancer progression.
• PSA level of at least 2.0 ng/mL.
• Must be taking bone health medications like zoledronic acid or denosumab for at least 4 weeks before joining the study.
• Good overall health with an ECOG performance status of 0 or 1.
• Little to no symptoms from the cancer (not needing strong painkillers).
• Allowed to have had one previous novel antiandrogen therapy (e.g., abiraterone, enzalutamide).
• Previous chemotherapy for hormone-sensitive prostate cancer is allowed if it was completed over a year ago.
• Adequate blood, kidney, and liver function.
• No other cancers in the past 5 years, except for certain skin cancers.
• Must provide tissue samples for genetic analysis, either from a biopsy or archived tissue.

Exclusion Criteria

• Cancer has spread to organs like the lungs, liver, or brain.
• Conditions that might need radiation or steroids for pain control, like spinal cord compression.
• Previous chemotherapy for advanced prostate cancer or any chemotherapy within the last year.
• Recent radiation therapy within the last 28 days.
• Recent treatment with certain radioactive drugs for bone metastases.
• Use of strong painkillers like morphine or oxycodone.
• Use of experimental drugs within the last 4 weeks.
• Urinary problems due to an intact prostate.
• Taking warfarin for blood thinning (other anticoagulants are allowed).
• Swelling in areas like the scrotum or legs due to lymph node disease.
• Serious uncontrolled medical conditions or infections.
• Any condition that might make testosterone therapy risky, like severe bone metastases.