High Dose Testosterone and Carboplatin Treatment for Men with Advanced Castration-Resistant Prostate Cancer

What this Trial Is About

Researchers are evaluating the effectiveness of bipolar androgen therapy BAT combined with carboplatin in men who have metastatic castrate-resistant prostate cancer mCRPC. This condition progresses despite low testosterone levels, and while androgen deprivation therapy ADT is standard, resistance develops over time. The study explores whether cycling testosterone levels can improve responses, particularly in men with DNA repair defects. Participants receive high dose testosterone enanthate injections of 500mg intramuscularly every 4 weeks alongside continuous LHRH therapy or after surgical removal of the testes, plus carboplatin chemotherapy dosed at AUC 5. This combination is being studied in a phase 2 trial to assess how well it works and its safety. During the study, mens prostate-specific antigen PSA levels will be monitored over one year to evaluate treatment response. Imaging and safety assessments will also occur to track disease progression and side effects. Participants must comply with scheduled visits, lab tests, and biopsies as part of the study, which is sponsored by St Vincents Hospital in Sydney.

Bipolar Androgen Therapy + Carboplatin in mCRPC