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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/study/NCT06594926
Registration number
NCT06594926
Ethics application status
Date submitted
23/05/2024
Date registered
19/09/2024
Date last updated
2/04/2025
Titles & IDs
Public title
Working Out M0 Bipolar Androgen Therapy
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Scientific title
Evaluating the Efficacy of Bipolar Androgen Therapy in Extending Metastasis-free Survival in Patients With M0 Castrate-resistant Prostate Cancer With PSA Progression But Not Radiological or Clinical Progression on Darolutamide
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Secondary ID [1]
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ANZUP 2201
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Universal Trial Number (UTN)
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Trial acronym
WOMBAT
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Prostate Cancer
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Condition category
Condition code
Cancer
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Prostate
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Treatment: Drugs - Testosterone Enanthate
Experimental: Testosterone enthanate - 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 (+3 days) except for cycle 1. 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.
Treatment: Drugs: Testosterone Enanthate
Testosterone enanthate is a depot formulation used in Australia typically for androgen replacement in people with confirmed testosterone deficiency.
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Intervention code [1]
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Treatment: Drugs
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Metastases free survival
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Assessment method [1]
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Based on PCWG3 criteria (appendix 2) and/or RECIST1.1 (appendix 1) on CT and WBBS imaging.
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Timepoint [1]
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From date of commencing Bipolar Androgen Therapy (BAT) until first documented evidence of metastatic disease or date of death, assessed every 8 weeks, on average 4 years
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Secondary outcome [1]
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Safety and tolerability of BAT + darolutamide
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Assessment method [1]
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The safety and tolerability of BAT + darolutamide (Incidence and grade of AEs by NCI CTCAE v5.0 Common Terminology Criteria for Adverse Events will be used to grade and classify adverse events after each cycle. Adverse events will be reported as all grade, grade 3-4, grade 5 and Adverse events of special interest (related to bipolar androgen therapy).
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Timepoint [1]
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Continuously throughout the study, from time of commencing BAT until 30 days after last dose of treatment
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Secondary outcome [2]
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The effect of BAT + darolutamide on Health-related Quality of Life QLQ-C30
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Assessment method [2]
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Using the European Organisation for Research Treatment of Cancer (EORTC) quality of life (QOL) questionnaire QLQ-C30. QLQ-C30 uses 28 questions about overall QOL with each question answerable using a scale from 1 (not at all) to 4 (very much). Overall scores can be from a minimum of 28 indicating a better QOL and higher scores with a maximum of 112 indicating lower overall QOL. It has two summary questions which asks participants to rank, 1) overall health and 2) overall QOL on scale from 1: very poor, to 7; excellent.
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Timepoint [2]
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During screening and then every 2 weeks upon commencement of BAT for 8 weeks and then every 4 weeks until last dose of treatment, on average 2 years.
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Secondary outcome [3]
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The effect of BAT + darolutamide on Health-related Quality of Life QLQ-PR25
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Assessment method [3]
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Using the European Organisation for Research Treatment of Cancer (EORTC) quality of life (QOL) questionnaire QLQ-PR25. QLQ-PR25 is a supplement to QLQ-C30 and designed to assess symptoms related to prostate cancer, treatment, and aspects of life related to prostate cancer.QLQ-PR25 uses 25 questions about overall QOL with each question answerable using a scale from 1 (not at all) to 4 (very much). Overall scores can be from a minimum of 25 indicating a better QOL and higher scores with a maximum of 100 indicating lower overall QOL.
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Timepoint [3]
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During screening and then every 2 weeks upon commencement of BAT for 8 weeks and then every 4 weeks until last dose of treatment, on average 2 years.
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Secondary outcome [4]
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PSA response rate to BAT + darolutamide
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Assessment method [4]
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By testing PSA level in blood. PSA response rate is defined as a PSA reduction of \>=50% from baseline as per PCWG3 criteria
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Timepoint [4]
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During screening and then every 2 weeks from the time of commencing BAT for first 8 weeks and then every 4 weeks until last dose of treatment, on average 2 years
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Secondary outcome [5]
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Time to PSA progression on BAT + darolutamide
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Assessment method [5]
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By testing PSA level in blood. PSA progression is defined as a PSA increase of \>=25% from baseline or nadir, confirmed on subsequent test \>=1 week later as per PCWG3)
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Timepoint [5]
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During screening and then every 2 weeks from the time of commencing BAT for first 8 weeks and then every 4 weeks until last dose of treatment, on average 2 years
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Secondary outcome [6]
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PSA and hormone kinetics in response to BAT + darolutamide. This will be assessed as a composite outcome.
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Assessment method [6]
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Blood tests assessing change in PSA, testosterone, oestradiol, Dihydrotestosterone (DHT), Dehydroepiandrosterone (DHEA), sex hormone-binding globulin (SBHG)
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Timepoint [6]
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Every 2 weeks for first 24 weeks from the time of commencing BAT
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Secondary outcome [7]
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The effect of BAT + darolutamide on metabolic and bone turnover markers and bone mineral density. This will be assessed as a composite outcome.
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Assessment method [7]
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Testing bone turnover markers via serum procollagen type I N propeptide (PINP) and plasma C-terminal cross-linking telopeptide of type I collagen (CTX). Bone densitometry imaging.
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Timepoint [7]
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Serum/plasma/urine - at screening and at 6 and 12 months on treatment. Bone densitometry imaging - at screening and 12 months on treatment.
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Eligibility
Key inclusion criteria
1. Histologically confirmed adenocarcinoma of the prostate
2. =18 years of age
3. ECOG performance status 0-1
4. 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).
5. 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
6. PSA >1.0 ng/mL during screening
7. Serum testosterone <1.7nmol/L and on an LHRH agonist/antagonist
8. Adequate bone marrow function (platelets > 100 x 109/L, ANC > 1.5 x 109/L, Hb >90)
9. Adequate liver function (ALT or AST < 2.5 x ULN, bilirubin < 1.5 x ULN)
10. Adequate renal function (creatinine <1.5 x ULN)
11. Willingness and ability to comply with study requirements, including treatment and timing of treatment.
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Minimum age
18
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Maximum age
No limit
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Sex
Males
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Can healthy volunteers participate?
No
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Key exclusion criteria
1. Life expectancy <3 months.
2. Neuroendocrine or small cell prostate cancer on any prior diagnostic tissue sample.
3. 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).
4. Current or prior treatment with enzalutamide, abiraterone, apalutamide, or cytotoxic chemotherapy. Prior first generation ARSI such as bicalutamide, flutamide, nilutamide are permitted.
5. 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.
6. 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.
7. Concurrent illness that could preclude the participant's ability to participate in the study and follow protocol with reasonable safety.
8. Planned ongoing drug Interactions as per protocol section 5.2.4 that are considered unable to be managed prior to study registration.
9. 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).
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Not applicable
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Open (masking not used)
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Who is / are masked / blinded?
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Intervention assignment
Single group
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Other design features
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Phase
Phase 2
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Recruiting
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
14/08/2024
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
31/12/2028
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Actual
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Sample size
Target
69
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Accrual to date
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Final
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Recruitment in Australia
Recruitment state(s)
NSW,QLD,SA,VIC
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Recruitment hospital [1]
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The Border Cancer Hospital - Albury
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Recruitment hospital [2]
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St Vincents Hospital - Darlinghurst
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Recruitment hospital [3]
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GenesisCare North Shore - St Leonards
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Recruitment hospital [4]
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Sydney Adventist Hospital - Wahroonga
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Recruitment hospital [5]
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ICON Cancer Centre - Chermside
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Recruitment hospital [6]
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Royal Adelaide Hospital - Adelaide
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Recruitment hospital [7]
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Grampians Health - Ballarat
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Recruitment hospital [8]
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Eastern Health - Box Hill - Box Hill
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Recruitment hospital [9]
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Cabrini Health - Malvern
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Recruitment postcode(s) [1]
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2640 - Albury
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Recruitment postcode(s) [2]
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2010 - Darlinghurst
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Recruitment postcode(s) [3]
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2065 - St Leonards
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Recruitment postcode(s) [4]
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2076 - Wahroonga
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Recruitment postcode(s) [5]
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4032 - Chermside
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Recruitment postcode(s) [6]
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5000 - Adelaide
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Recruitment postcode(s) [7]
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3350 - Ballarat
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Recruitment postcode(s) [8]
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3128 - Box Hill
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Recruitment postcode(s) [9]
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3144 - Malvern
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Funding & Sponsors
Primary sponsor type
Other
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Name
Australian and New Zealand Urogenital and Prostate Cancer Trials Group
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Address
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Country
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Other collaborator category [1]
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Commercial sector/industry
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Name [1]
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Bayer
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Address [1]
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Country [1]
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Other collaborator category [2]
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Other
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Name [2]
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The George Institute
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Address [2]
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Country [2]
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Other collaborator category [3]
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Other
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Name [3]
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HMRI
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Address [3]
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Country [3]
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Ethics approval
Ethics application status
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Summary
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 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)
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Trial website
https://clinicaltrials.gov/study/NCT06594926
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
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Anthony Joshua
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Address
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St Vincent's Hospital, Sydney
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Country
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Phone
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Fax
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Email
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Contact person for public queries
Name
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Antoinette Fontela, BSc
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Address
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Country
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Phone
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+61 2 9046 8954
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Fax
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Email
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[email protected]
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Contact person for scientific queries
Data sharing statement
What supporting documents are/will be available?
No Supporting Document Provided
Results publications and other study-related documents
No documents have been uploaded by study researchers.
Results not provided in
https://clinicaltrials.gov/study/NCT06594926
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