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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

Titles & IDs
Public title
Working Out M0 Bipolar Androgen Therapy
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
Secondary ID [1] 0 0
ANZUP 2201
Universal Trial Number (UTN)
Trial acronym
WOMBAT
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Prostate Cancer 0 0
Condition category
Condition code
Cancer 0 0 0 0
Prostate

Intervention/exposure
Study type
Interventional
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.
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Metastases free survival
Timepoint [1] 0 0
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
Secondary outcome [1] 0 0
Safety and tolerability of BAT + darolutamide
Timepoint [1] 0 0
Continuously throughout the study, from time of commencing BAT until 30 days after last dose of treatment
Secondary outcome [2] 0 0
The effect of BAT + darolutamide on Health-related Quality of Life QLQ-C30
Timepoint [2] 0 0
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.
Secondary outcome [3] 0 0
The effect of BAT + darolutamide on Health-related Quality of Life QLQ-PR25
Timepoint [3] 0 0
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.
Secondary outcome [4] 0 0
PSA response rate to BAT + darolutamide
Timepoint [4] 0 0
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
Secondary outcome [5] 0 0
Time to PSA progression on BAT + darolutamide
Timepoint [5] 0 0
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
Secondary outcome [6] 0 0
PSA and hormone kinetics in response to BAT + darolutamide. This will be assessed as a composite outcome.
Timepoint [6] 0 0
Every 2 weeks for first 24 weeks from the time of commencing BAT
Secondary outcome [7] 0 0
The effect of BAT + darolutamide on metabolic and bone turnover markers and bone mineral density. This will be assessed as a composite outcome.
Timepoint [7] 0 0
Serum/plasma/urine - at screening and at 6 and 12 months on treatment. Bone densitometry imaging - at screening and 12 months on treatment.

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. PSA >2 ng/mL during screening
6. Serum testosterone <1.7nmol/L and on an LHRH agonist/antagonist
7. Adequate bone marrow function (platelets > 100 x 109/L, ANC > 1.5 x 109/L, Hb >90)
8. Adequate liver function (ALT or AST < 2.5 x ULN, bilirubin < 1.5 x ULN)
9. Adequate renal function (creatinine <1.5 x ULN) 10. Willingness and ability to comply with study requirements, including treatment and timing of treatment.
Minimum age
18 Years
Maximum age
No limit
Sex
Males
Can healthy volunteers participate?
No
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). Metastatic prostate cancer evident only on PSMA PET (without correlation on CT and bone scan or on the CT component of a PET/CT) is not an exclusion.
4. Current or prior treatment with enzalutamide, abiraterone, apalutamide, or cytotoxic chemotherapy. Ketoconazole and cyproterone are also excluded. 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 5 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. Participants with a history of other malignancies are eligible if they have been continuously disease-free for at least 5 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).

Study design
Purpose of the study
Treatment
Allocation to intervention
Not applicable
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Phase 2
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
14/08/2024
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
31/12/2028
Actual
Sample size
Target
69
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW,QLD,SA,VIC
Recruitment hospital [1] 0 0
St Vincents Hospital - Darlinghurst
Recruitment hospital [2] 0 0
GenesisCare North Shore - St Leonards
Recruitment hospital [3] 0 0
Sydney Adventist Hospital - Wahroonga
Recruitment hospital [4] 0 0
ICON Cancer Centre - Chermside
Recruitment hospital [5] 0 0
Royal Adelaide Hospital - Adelaide
Recruitment hospital [6] 0 0
Grampians Health - Ballarat
Recruitment hospital [7] 0 0
Cabrini Health - Malvern
Recruitment postcode(s) [1] 0 0
2010 - Darlinghurst
Recruitment postcode(s) [2] 0 0
2065 - St Leonards
Recruitment postcode(s) [3] 0 0
2076 - Wahroonga
Recruitment postcode(s) [4] 0 0
4032 - Chermside
Recruitment postcode(s) [5] 0 0
5000 - Adelaide
Recruitment postcode(s) [6] 0 0
3350 - Ballarat
Recruitment postcode(s) [7] 0 0
3144 - Malvern

Funding & Sponsors
Primary sponsor type
Other
Name
Australian and New Zealand Urogenital and Prostate Cancer Trials Group
Address
Country
Other collaborator category [1] 0 0
Commercial sector/industry
Name [1] 0 0
Bayer
Address [1] 0 0
Country [1] 0 0
Other collaborator category [2] 0 0
Other
Name [2] 0 0
The George Institute
Address [2] 0 0
Country [2] 0 0
Other collaborator category [3] 0 0
Other
Name [3] 0 0
HMRI
Address [3] 0 0
Country [3] 0 0

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Anthony Joshua
Address 0 0
St Vincent's Hospital, Sydney
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Antoinette Fontela, BSc
Address 0 0
Country 0 0
Phone 0 0
+61 2 9046 8954
Fax 0 0
Email 0 0
Trials@anzup.org.au
Contact person for scientific queries

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


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