Actively Recruiting
Working Out M0 Bipolar Androgen Therapy
Led by Australian and New Zealand Urogenital and Prostate Cancer Trials Group · Updated on 2026-04-24
69
Participants Needed
12
Research Sites
228 weeks
Total Duration
On this page
Sponsors
A
Australian and New Zealand Urogenital and Prostate Cancer Trials Group
Lead Sponsor
B
Bayer
Collaborating Sponsor
AI-Summary
What this Trial Is About
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)
CONDITIONS
Official Title
Working Out M0 Bipolar Androgen Therapy
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Histologically confirmed adenocarcinoma of the prostate
- 18 years of age or older
- ECOG performance status 0-1
- PSA progression on darolutamide with three rising PSA levels at least 1 week apart and castrate testosterone level (<1.7 nmol/L)
- No metastatic disease (M0) on conventional imaging (whole body bone scan and CT scan)
- Previous PSMA PET M1 disease now M0 CRPC after >18 months of ADT + darolutamide allowed
- Pelvic lymph nodes up to 2cm in short-axis permitted
- PSA greater than 1.0 ng/mL during screening
- Serum testosterone less than 1.7 nmol/L and on LHRH agonist or antagonist
- Adequate bone marrow function (platelets > 100 x 10^9/L, ANC > 1.5 x 10^9/L, hemoglobin > 90)
- Adequate liver function (ALT or AST < 2.5 x ULN, bilirubin < 1.5 x ULN)
- Adequate renal function (creatinine < 1.5 x ULN)
- Willingness and ability to comply with study requirements including treatment and timing
You will not qualify if you...
- Life expectancy less than 3 months
- Neuroendocrine or small cell prostate cancer on any prior tissue sample
- Metastatic prostate cancer on conventional imaging (except pelvic nodes up to 2cm)
- Current or prior treatment with enzalutamide, abiraterone, apalutamide, or chemotherapy (except prior docetaxel with criteria)
- Current or prior significant cardiac or thromboembolic risk including recent myocardial infarction, unstable angina, uncontrolled cardiac disease, or significant uncontrolled hypertension
- Other malignancy within 2 years except treated skin or non-muscle invasive bladder cancer or other malignancies disease-free for 2 years
- Concurrent illness that could prevent safe participation
- Planned drug interactions that cannot be managed prior to registration
- Radiation therapy within 4 weeks prior to study (with exceptions for SBRT to PSMA PET only disease)
AI-Screening
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Trial Site Locations
Total: 12 locations
1
The Canberra Hospital
Garran, Australian Capital Territory, Australia, 2605
Actively Recruiting
2
The Border Cancer Hospital
Albury, New South Wales, Australia, 2640
Terminated
3
St Vincents Hospital
Darlinghurst, New South Wales, Australia, 2010
Actively Recruiting
4
GenesisCare North Shore
St Leonards, New South Wales, Australia, 2065
Actively Recruiting
5
Sydney Adventist Hospital
Wahroonga, New South Wales, Australia, 2076
Actively Recruiting
6
ICON Cancer Centre
Chermside, Queensland, Australia, 4032
Actively Recruiting
7
Mater Misericordiae Ltd - QLD
South Brisbane, Queensland, Australia, 4101
Actively Recruiting
8
Royal Adelaide Hospital
Adelaide, South Australia, Australia, 5000
Actively Recruiting
9
Grampians Health
Ballarat, Victoria, Australia, 3350
Actively Recruiting
10
Eastern Health - Box Hill
Box Hill, Victoria, Australia, 3128
Actively Recruiting
11
Cabrini Health
Malvern, Victoria, Australia, 3144
Actively Recruiting
12
Northeast Health Wangaratta
Wangaratta, Victoria, Australia, 3677
Actively Recruiting
Research Team
A
Antoinette Fontela, BSc
CONTACT
J
Jennifer Thompson, BSc
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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