OncoMatch/Clinical Trials/NCT06594926
Working Out M0 Bipolar Androgen Therapy
Is NCT06594926 recruiting? Yes, currently enrolling (May 2026). This Phase 2 trial studies Testosterone Enanthate for prostate cancer.
Treatment: Testosterone Enanthate — 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)
Check if I qualifyExtracted eligibility criteria
Cancer type
Prostate Cancer
Disease stage
Excluded: Stage METASTATIC PROSTATE CANCER ON CONVENTIONAL IMAGING
AJCC stage M0 on conventional imaging. Metastatic prostate cancer on conventional imaging (WBBS or CT scan) at any point in disease course [excluded]
Performance status
ECOG 0–1(Restricted strenuous activity)
Prior therapy
Must have received: androgen receptor signaling inhibitor (darolutamide) — on therapy at time of progression
PSA progression while on darolutamide
Must have received: androgen deprivation therapy — hormone-sensitive setting
Previous PSMA PET only M1 disease in the hormone-sensitive setting that is now M0 CRPC on conventional imaging following >18 months of ADT + darolutamide are eligible
Cannot have received: androgen receptor signaling inhibitor (enzalutamide, abiraterone, apalutamide)
Current or prior treatment with enzalutamide, abiraterone, apalutamide
Cannot have received: cytotoxic chemotherapy
Exception: Patients with pelvic nodal metastases (below the aortic bifurcation) <2cm in short axis at original diagnosis who ceased cytotoxic chemotherapy (docetaxel) at least 12 months prior to C1D1 are eligible
Current or prior treatment with cytotoxic chemotherapy
Lab requirements
Blood counts
platelets > 100 x 10^9/l, anc > 1.5 x 10^9/l, hb >90
Kidney function
creatinine <1.5 x uln
Liver function
alt or ast < 2.5 x uln, bilirubin < 1.5 x uln
Structured fields extracted by AI. May contain errors — verify against the official protocol.
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