Working Out M0 Bipolar Androgen Therapy

  • Recruiting
  • Treatment
  • Interventional
  • Drug
  • PHASE2
  • Australian and New Zealand Urogenital and Prostate Cancer Trials Group
  • 18 Years -


Study Purpose

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)

Intervention

Drug : Testosterone Enanthate


Eligibility Requirements

info icon Histologically confirmed adenocarcinoma of the prostate

info icon ≥18 years of age

info icon ECOG performance status 0-1

info icon 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).

info icon AJCC stage M0 on conventional imaging. 1. 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. 2. Nodes up to 2cm in short-axis in pelvis are permitted

info icon PSA \>1.0 ng/mL during screening

info icon Serum testosterone \<1.7nmol/L and on an LHRH agonist/antagonist

info icon Adequate bone marrow function (platelets \> 100 x 109/L, ANC \> 1.5 x 109/L, Hb \>90)

info icon Adequate liver function (ALT or AST \< 2.5 x ULN, bilirubin \< 1.5 x ULN)

info icon Adequate renal function (creatinine \<1.5 x ULN)

info icon Willingness and ability to comply with study requirements, including treatment and timing of treatment.

info icon Life expectancy \<3 months.

info icon Neuroendocrine or small cell prostate cancer on any prior diagnostic tissue sample.

info icon 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).

info icon Current or prior treatment with enzalutamide, abiraterone, apalutamide, or cytotoxic chemotherapy. Prior first generation ARSI such as bicalutamide, flutamide, nilutamide are permitted.

info icon Current or pre-existing cardiac or thromboembolic risk factors, including but not limited to:

info icon 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.

info icon 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.

info icon 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.

info icon Concurrent illness that could preclude the participant's ability to participate in the study and follow protocol with reasonable safety.

info icon Planned ongoing drug Interactions as per protocol section 5.2.4 that are considered unable to be managed prior to study registration.

info icon 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).

Recruiting status

Recruiting

Estimated enrollment

69

 
Study start date

Aug 14, 2024

Study end date

Dec 31, 2028

Last updated

Mar 23, 2025

Primary purpose

Treatment

Design

Interventional

Intervention

Drug

Study phase

PHASE2

Allocation

Na

 

Sponsor:

Australian and New Zealand Urogenital and Prostate Cancer Trials Group

Collaborator:

Bayer

The George Institute

HMRI

Investigator:

Anthony Joshua

NCT06594926

Clinic Location Investigator Distance RECRUITING STATUS Contact