Status:
RECRUITING
Working Out M0 Bipolar Androgen Therapy
Lead Sponsor:
Australian and New Zealand Urogenital and Prostate Cancer Trials Group
Collaborating Sponsors:
Bayer
The George Institute
Conditions:
Prostate Cancer
Eligibility:
MALE
18+ years
Phase:
PHASE2
Brief Summary
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...
Detailed Description
This is a study to assess the efficacy and safety of cyclical testosterone and darolutamide in non-metastatic castration-resistant prostate cancer. Adults with castrate resistant prostate cancer, wit...
Eligibility Criteria
Inclusion
- Histologically confirmed adenocarcinoma of the prostate
- ≥18 years of age
- ECOG performance status 0-1
- PSA progression while on darolutamide defined as three rising PSA (1 baseline and 2 consecutive rises) levels at least 1 week apart despite castrate testosterone level (\<1.7nmol/L). Patients with a minor subsequent PSA fall, provided there was no intervening therapy since the three consecutive rises, are eligible
- AJCC stage M0 on conventional imaging.
- 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.
- Nodes up to 2cm in short-axis in pelvis are permitted
- PSA \>1.0 ng/mL during screening
- Serum testosterone \<1.7nmol/L and on an LHRH agonist/antagonist
- Adequate bone marrow function (platelets \> 100 x 109/L, ANC \> 1.5 x 109/L, Hb \>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 of treatment.
Exclusion
- Life expectancy \<3 months.
- Neuroendocrine or small cell prostate cancer on any prior diagnostic tissue sample.
- Metastatic prostate cancer on conventional imaging (WBBS or CT scan) at any point in disease course (except for pathological nodes up to 2cm in short axis in the pelvis).
- Current or prior treatment with enzalutamide, abiraterone, apalutamide, or cytotoxic chemotherapy. 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. Prior first generation ARSI such as bicalutamide, flutamide, nilutamide are permitted.
- Current or pre-existing cardiac or thromboembolic risk factors, including but not limited to:
- i. Prior myocardial infarction, or unstable angina within 24 months of study entry, ii. Uncontrolled or symptomatic cardiac disease including, but not limited to angina, dyspnoea on exertion, orthopnoea; cardiac failure (NYHA classification 3-4) or uncontrolled arrhythmias.
- iii. Significant co-morbidities that increase cardiovascular risk, including significant hypertension (Baseline systolic BP\>160 or diastolic BP\>100 despite optimal treatment) that are uncontrolled, as assessed by the treating oncologist.
- Another malignancy diagnosis within 2 years before registration. Participants with a history of treated carcinoma in situ, basal cell carcinoma of the skin, squamous cell carcinoma of the skin, or non-muscle invasive urothelial carcinoma of the bladder are eligible if malignancy has been treated with curative intent. Participants with a history of other malignancies are eligible if they have been continuously disease-free for at least 2 years after definitive primary treatment or the chance of recurrence is sufficiently low as to be very unlikely to affect study outcomes according to the treating local oncologist.
- Concurrent illness that could preclude the participant's ability to participate in the study and follow protocol with reasonable safety.
- Planned ongoing drug Interactions as per protocol section 5.2.4 that are considered unable to be managed prior to study registration.
- Radiation therapy within the previous 4 weeks (participants are permitted to have SBRT to PSMA PET only disease prior to study enrolment if they continue on darolutamide. Note that if the metastases are visible on conventional imaging at the time of radiation treatment the participant is not eligible).
Key Trial Info
Start Date :
August 14 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 31 2028
Estimated Enrollment :
69 Patients enrolled
Trial Details
Trial ID
NCT06594926
Start Date
August 14 2024
End Date
December 31 2028
Last Update
November 26 2025
Active Locations (12)
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1
The Canberra Hospital
Garran, Australian Capital Territory, Australia, 2605
2
The Border Cancer Hospital
Albury, New South Wales, Australia, 2640
3
St Vincents Hospital
Darlinghurst, New South Wales, Australia, 2010
4
GenesisCare North Shore
St Leonards, New South Wales, Australia, 2065