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New treatment option for Prostate Cancer
Official title Working Out M0 Bipolar Androgen Therapy
ClinicalTrials.gov ID: NCT06594926
What this study is testing
What is Testosterone Enanthate?
Testosterone Enanthate is an investigational medicine, given as an injection into a muscle, being studied as a potential treatment for prostate cancer.
Also referred to as Primoteston Depot.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 2: a mid-size study of how well it works
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older, men only
You may be able to join if
- 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...
- AJCC stage M0 on conventional imaging.
You likely can't join if
- 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...
- Current or prior treatment with enzalutamide, abiraterone, apalutamide, or cytotoxic chemotherapy. Patients with pelvic nodal metastases (below the...
- Current or pre-existing cardiac or thromboembolic risk factors, including but not limited to: i. Prior myocardial infarction, or unstable angina...
- Another malignancy diagnosis within 2 years before registration. Participants with a history of treated carcinoma in situ, basal cell carcinoma of...
See the full eligibility criteria
- 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...
- 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.
- 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...
- 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...
- 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...
- 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...
The study team makes the final eligibility decision.
Where it's taking place
- Garran, Australian Capital Territory, Australia
- Albury, New South Wales, Australia
- Darlinghurst, New South Wales, Australia
- St Leonards, New South Wales, Australia
- Wahroonga, New South Wales, Australia
- Chermside, Queensland, Australia
- South Brisbane, Queensland, Australia
- Adelaide, South Australia, Australia
- Ballarat, Victoria, Australia
- Box Hill, Victoria, Australia
- Malvern, Victoria, Australia
- Wangaratta, Victoria, Australia
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling male, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Garran, Australian Capital Territory, Australia; Albury, New South Wales, Australia; Darlinghurst, New South Wales, Australia; St Leonards, New South Wales, Australia; Wahroonga, New South Wales, Australia; Chermside, Queensland, Australia and 6 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.