Meanwhile in Oz, another BAT trial…the WOMBAT Trial (Working Out M0 Bipolar Androgen Therapy), represents an innovative approach to prostate cancer management. This Phase 2 trial is registered with the Australian New Zealand Clinical Trials Registry (ANZCTR) under the identification ANZUP 2201.

Recruitment is active (started in November 2024) in New South Wales, Australia, at sites including:

• • Sydney Adventist Hospital – Wahroonga
  • The Royal Adelaide Hospital – Adelaide
  • GenesisCare – North Shore – St Leonards

The trial targets 69 participants, with the final data collection projected for September 30, 2027.

The primary objective is to evaluate the efficacy of bipolar androgen therapy (BAT) in extending metastasis-free survival (MFS) in patients with M0 castration-resistant prostate cancer (CRPC). These patients exhibit rising prostate-specific antigen (PSA) levels while on darolutamide, without detectable metastases on imaging.

The trial will then assess the safety and tolerability of BAT combined with darolutamide, health-related quality of life, PSA response rates, time to PSA progression, hormone and PSA kinetics, metabolic and bone turnover markers

Participants will undergo bipolar androgen therapy (BAT), delivered in 56-day cycles, alongside standard castration therapy.

Source.