Prostate CancerPhase 2WOMBATNCT06594926
Working Out M0 Bipolar Androgen Therapy
A Phase 2 study testing Testosterone Enanthate in people with Prostate Cancer, run by Australian and New Zealand Urogenital and Prostate Cancer Trials Group at 12 sites in Australia.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older, men only
- Conditions the study is for
- Prostate Cancer
- What is being tested?
- Testosterone Enanthate
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 69 participants
- Where
- 12 sitesAustralia
- Study dates
- 14 Aug 2024to 31 Dec 2028
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
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- 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.
Who cannot join
- 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:
- 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.
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- 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).
Trial locations and contacts
12 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Jennifer Thompson, BSc contact
12 sites in 1 country
Australia12 sites, 11 recruiting
- Recruiting
Royal Adelaide Hospital
Adelaide, South Australia, 5000
Sonya Stephens, sonya.stephens@sa.gov.au
Thean Hsiang Tan
- Terminated
The Border Cancer Hospital
Albury, New South Wales, 2640
- Recruiting
Grampians Health
Ballarat, Victoria, 3350
Belinda Mende, Belinda.Mende@gh.org.au
Sharad Sharma
- Recruiting
Eastern Health - Box Hill
Box Hill, Victoria, 3128
Sue Cranmer, 0390949529, sue.cranmer@monash.edu
Karen Lim, 0390949529, karen.lim@monash.edu
- Recruiting
ICON Cancer Centre
Chermside, Queensland, 4032
Jesse Peet, jesse.peet@icon.team
Jeffrey Goh
- Recruiting
St Vincents Hospital
Darlinghurst, New South Wales, 2010
Angelina Lay, angelina.lay@svha.org.au
Anthony Joshua, MBBS FRACP
- Recruiting
The Canberra Hospital
Garran, Australian Capital Territory, 2605
Monika Tencic, +61251244102, monika.tencic@act.gov.au
Olga Krepysheva, +6125124 3688, olga.krepysheva@act.gov.au
- Recruiting
Cabrini Health
Malvern, Victoria, 3144
Dina Cherfi, DCherfi@cabrini.com.au
David Pook
- Recruiting
Mater Misericordiae Ltd - QLD
South Brisbane, Queensland, 4101
Claire Jackson, +6173163 6342, Claire.Jackson1@mater.org.au
Dan Krytskyi, +6273163 6313, dan.krytskyi@mater.org.au
- Recruiting
GenesisCare North Shore
St Leonards, New South Wales, 2065
Suzi Jakicic, Suzi.Jakicic@genesiscare.com
Laurence Krieger
- Recruiting
Sydney Adventist Hospital
Wahroonga, New South Wales, 2076
Gloria Jeong, 029480 6285, gloria.jeong@sah.org.au
Gavin Marx
- Recruiting
Northeast Health Wangaratta
Wangaratta, Victoria, 3677
Nicole Humphreys, +6135722 5521, nicole.humphreys@nhw.org.au
Kay Xu
About this study
Official 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
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.
Read more
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)
Read 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, with no evidence of metastatic disease (M0) on conventional imaging [Whole Body Bone Scan (WBBS) and Computed Tomography (CT) scan at screening] and prostate specific antigen (PSA) only progression on darolutamide may be eligible.
Study participants will receive cyclical treatment with intramuscular (IM) testosterone, darolutamide and ongoing medical/surgical castration. This will be delivered in 56-day cycles until evidence of metastatic disease on conventional imaging unless treated beyond progression. Participants will be asked to provide blood samples, complete questionnaires and undergo scans during their treatment.
It is hoped that findings from this study will help develop new treatment pathways for those with non-metastatic castration-resistant prostate cancer.
- Conditions
- Prostate Cancer
- Being tested
- Testosterone Enanthate
- Keywords
- darolutamide, testosterone, bipolar androgen therapy
- Medical subject headings
- Prostatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Testosterone EnanthateDrug
Also called Primoteston Depot
Testosterone enanthate is a depot formulation used in Australia typically for androgen replacement in people with confirmed testosterone deficiency.
| Study group | Role | What they receive |
|---|---|---|
| Testosterone enthanate | Experimental | 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. Receives: Drug: Testosterone Enanthate |
What is being measured
The primary outcome is the main question the study is designed to answer.
Metastases free survival
Based on PCWG3 criteria (appendix 2) and/or RECIST1.1 (appendix 1) on CT and WBBS imaging.
Measured: 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 outcomes (7)
Safety and tolerability of BAT + darolutamide
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).
Measured: Continuously throughout the study, from time of commencing BAT until 30 days after last dose of treatment
The effect of BAT + darolutamide on Health-related Quality of Life QLQ-C30
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.
Measured: 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.
The effect of BAT + darolutamide on Health-related Quality of Life QLQ-PR25
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.
Measured: 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.
PSA response rate to BAT + darolutamide
By testing PSA level in blood. PSA response rate is defined as a PSA reduction of >=50% from baseline as per PCWG3 criteria
Measured: 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
Time to PSA progression on BAT + darolutamide
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)
Measured: 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
PSA and hormone kinetics in response to BAT + darolutamide. This will be assessed as a composite outcome.
Blood tests assessing change in PSA, testosterone, oestradiol, Dihydrotestosterone (DHT), Dehydroepiandrosterone (DHEA), sex hormone-binding globulin (SBHG)
Measured: Every 2 weeks for first 24 weeks from the time of commencing BAT
The effect of BAT + darolutamide on metabolic and bone turnover markers and bone mineral density. This will be assessed as a composite outcome.
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.
Measured: Serum/plasma/urine - at screening and at 6 and 12 months on treatment. Bone densitometry imaging - at screening and 12 months on treatment.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Sep 2024
- Study start14 Aug 2024
- Primary completion31 Dec 2026 (estimated)
- Study completion31 Dec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Prostate CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- This is a single-arm phase 2 prospective, interventional study to assess the efficacy and safety of cyclical testosterone and darolutamide in non-metastatic castration-resistant prostate cancer.
- Masking
- None (open label)
- Enrolment
- 69 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Australian and New Zealand Urogenital and Prostate Cancer Trials Group
- Sponsor type
- University, hospital or other
- Collaborators
- Bayer, The George Institute, HMRI
- Responsible party
- Sponsor
- Investigators
- Anthony Joshua, Study chair, St Vincent's Hospital, Sydney
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06594926
- Sponsor's protocol ID
- ANZUP 2201
- Acronym
- WOMBAT
- Status last verified
- Apr 2026
- First submitted
- 23 May 2024
- Last updated
- 24 Apr 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Talmor B, Harris CA, Gianacas C, Pook D, Tan TH, Davis ID, Krieger L, Marx G, Anton A, Sharma S, Goh JC, Xu K, Pranavan G, Dhillon HM, Antonarakis ES, Denmeade SR, Horvath L, Oakes SR, Allen R, Fontela A, Reich E, Crumbaker M, Hurwitz J, Joshua AM. WOMBAT (ANZUP 2201): A Phase 2, Single-arm Study of Bipolar Androgen Therapy in Patients with Nonmetastatic Castration-resistant Prostate Cancer with Prostate-specific Antigen Progression on Darolutamide. Eur Urol Oncol. 2026 Apr;9(2):472-478. doi: 10.1016/j.euo.2026.02.004. Epub 2026 Feb 21.
PubMed 41724634
Study at a glance
From the registry record, last updated by the sponsor on 24 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official 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
- ClinicalTrials.gov ID
- NCT06594926
- Acronym / sponsor ID
- WOMBAT / ANZUP 2201
- Conditions
- Prostate Cancer
- Keywords
- darolutamide, testosterone, bipolar androgen therapy
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 69 participants (estimated)
- Lead sponsor
- Australian and New Zealand Urogenital and Prostate Cancer Trials GroupUniversity, hospital or other
- Collaborators
- Bayer, The George Institute, HMRI
- Study start
- 14 Aug 2024 (actual)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 31 Dec 2028 (estimated)
- First posted
- 19 Sep 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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)
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, with no evidence of metastatic disease (M0) on conventional imaging [Whole Body Bone Scan (WBBS) and Computed Tomography (CT) scan at screening] and prostate specific antigen (PSA) only progression on darolutamide may be eligible.
Study participants will receive cyclical treatment with intramuscular (IM) testosterone, darolutamide and ongoing medical/surgical castration. This will be delivered in 56-day cycles until evidence of metastatic disease on conventional imaging unless treated beyond progression. Participants will be asked to provide blood samples, complete questionnaires and undergo scans during their treatment.
It is hoped that findings from this study will help develop new treatment pathways for those with non-metastatic castration-resistant prostate cancer.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- This is a single-arm phase 2 prospective, interventional study to assess the efficacy and safety of cyclical testosterone and darolutamide in non-metastatic castration-resistant prostate cancer.
| Arm | Type | Receives |
|---|---|---|
| Testosterone enthanate | Experimental | Drug: Testosterone EnanthateParticipants 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (13 listed)
- 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.
Key exclusion criteria (11 listed)
- 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:
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Testosterone EnanthateAlso: Primoteston DepotTestosterone enanthate is a depot formulation used in Australia typically for androgen replacement in people with confirmed testosterone deficiency. | Drug | Testosterone enthanate |
Primary outcome
Metastases free survival
Time frame: 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
Based on PCWG3 criteria (appendix 2) and/or RECIST1.1 (appendix 1) on CT and WBBS imaging.
7 secondary outcomes
Safety and tolerability of BAT + darolutamide
Time frame: Continuously throughout the study, from time of commencing BAT until 30 days after last dose of treatment
The effect of BAT + darolutamide on Health-related Quality of Life QLQ-C30
Time frame: 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.
The effect of BAT + darolutamide on Health-related Quality of Life QLQ-PR25
Time frame: 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.
PSA response rate to BAT + darolutamide
Time frame: 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
Time to PSA progression on BAT + darolutamide
Time frame: 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
PSA and hormone kinetics in response to BAT + darolutamide. This will be assessed as a composite outcome.
Time frame: Every 2 weeks for first 24 weeks from the time of commencing BAT
The effect of BAT + darolutamide on metabolic and bone turnover markers and bone mineral density. This will be assessed as a composite outcome.
Time frame: Serum/plasma/urine - at screening and at 6 and 12 months on treatment. Bone densitometry imaging - at screening and 12 months on treatment.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Apr 2026.
- Derived from this study: PubMed 41724634Talmor B, Harris CA, Gianacas C, Pook D, Tan TH, Davis ID, Krieger L, Marx G, Anton A, Sharma S, Goh JC, Xu K, Pranavan G, Dhillon HM, Antonarakis ES, Denmeade SR, Horvath L, Oakes SR, Allen R, Fontela A, Reich E, Crumbaker M, Hurwitz J, Joshua AM. WOMBAT (ANZUP 2201): A Phase 2, Single-arm Study of Bipolar Androgen Therapy in Patients with Nonmetastatic Castration-resistant Prostate Cancer with Prostate-specific Antigen Progression on Darolutamide. Eur Urol Oncol. 2026 Apr;9(2):472-478. doi: 10.1016/j.euo.2026.02.004. Epub 2026 Feb 21.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Jennifer Thompson, BSc contact
Anthony Joshua study chair
St Vincent's Hospital, Sydney
12 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Testosterone Enanthate in people with Prostate Cancer, run by Australian and New Zealand Urogenital and Prostate Cancer Trials Group at 12 sites in Australia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 13 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 24 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 12 sites in Australia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Antoinette Fontela, BSc (+61 2 9046 8954, Trials@anzup.org.au), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Metastases free survival (time frame: 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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06594926, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Apr 2026.