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Study identifier: NCT06594926 Synced from ClinicalTrials.gov · July 28, 2026
● Recruiting

Working Out M0 Bipolar Androgen Therapy

Condition: Prostate Cancer  ·  Sponsor: Australian and New Zealand Urogenital and Prostate Cancer Trials Group

PhasePhase 2
Planned participants69
Who can joinMale, 18 Years to no upper limit
Healthy volunteersNo

About this study

The WOMBAT study will test if BAT can prolong the time it takes for nmCRPC prostate cancer to become detectable in other areas of the body (metastatic disease). Approximately 69 participants over the age of 18 with castrate resistant prostate cancer, no evidence of metastatic disease (M0) on conventional imaging (WBBS and CT scan at screening) and PSA only progression on darolutamide will be enrolled from approximately 8 sites within Australia. Participants will receive continuous androgen deprivation therapy with LHRH agonists/antagonists. The study intervention will be IM testosterone enthanate, injected on day 1 of each 56-day cycle. Concurrent darolutamide will be taken at a dose of 600mg BD on days 29-56 of each cycle. Both LHRH and agonist/antagonist and darolutamide are supplied through the PBS as standard of care medications. Administration of both testosterone and darolutamide will continue until disease progression, beyond disease progression, unacceptable toxicity, death, withdrawal of consent or study Sponsor termination of the study. Primary objective (endpoint) is to determine the metastasis-free survival (time from commencing BAT to evidence of metastases or death)

This description comes directly from the study's public registry record.

Talk to the study team

Antoinette Fontela, BSc  ·  +61 2 9046 8954  ·  Trials@anzup.org.au

Jennifer Thompson, BSc  ·  jennifer.thompson@anzup.org.au

Always discuss trial participation with your own doctor first.

Locations (12)

The Canberra HospitalGarran, Australian Capital Territory, AustraliaRecruiting
The Border Cancer HospitalAlbury, New South Wales, AustraliaTerminated
St Vincents HospitalDarlinghurst, New South Wales, AustraliaRecruiting
GenesisCare North ShoreSt Leonards, New South Wales, AustraliaRecruiting
Sydney Adventist HospitalWahroonga, New South Wales, AustraliaRecruiting
ICON Cancer CentreChermside, Queensland, AustraliaRecruiting
Mater Misericordiae Ltd - QLDSouth Brisbane, Queensland, AustraliaRecruiting
Royal Adelaide HospitalAdelaide, South Australia, AustraliaRecruiting
Grampians HealthBallarat, Victoria, AustraliaRecruiting
Eastern Health - Box HillBox Hill, Victoria, AustraliaRecruiting
Cabrini HealthMalvern, Victoria, AustraliaRecruiting
Northeast Health WangarattaWangaratta, Victoria, AustraliaRecruiting

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Source record: clinicaltrials.gov/study/NCT06594926