The WOMBAT Trial (Working Out M0 Bipolar Androgen Therapy) investigates the efficacy of bipolar androgen therapy (BAT) in extending metastasis-free survival for patients with M0 castration-resistant prostate cancer (CRPC) experiencing rising PSA levels on darolutamide, without visible metastases.
This Phase 2, open-label trial targets 69 participants in New South Wales, Australia, with recruitment spanning November 2024 to August 2027.
Participants will receive testosterone enanthate (500mg, intramuscularly) in 56-day cycles, alongside darolutamide and standard castration therapy. The study also examines safety, PSA progression, quality of life, and hormone kinetics. Sponsored by Bayer and led by the ANZUP Cancer Trials Group, this innovative trial aims to redefine CRPC treatment pathways by reintroducing testosterone in controlled bursts.