WOMBAT

 Prostate — Recruiting

WOMBAT
Hormone therapy is a cancer treatment that slows or stops the growth of cancer by blocking the chemical (hormone) it uses to grow. Testosterone is the male sex hormone, and prostate cancer cells often rely on testosterone for their survival and growth. Treatments to reduce testosterone, also known as androgen deprivation therapy (ADT), are frequently used to treat prostate cancer. ADT can cause side effects related to the low levels of testosterone. Prostate cancer cells can work out ways to grow despite low levels of testosterone. This often shows up as an increase in the number produced from a blood test called prostate-specific antigen (PSA). If the PSA number rises without any sign of cancer on scans, the situation is known as “non-metastatic” castrate resistant prostate cancer (nmCRPC). The current standard treatment for nmCRPC is to continue ADT and to add in other treatments to block leftover effects of testosterone action. One such treatment is darolutamide, which is known to delay the time until spread of prostate cancer can be seen on scans. Bipolar Androgen Therapy (BAT) is an experimental treatment for nmCRPC where people receive standard treatment with darolutamide and ADT, and also receive cycles of treatment with testosterone injections. BAT might “resensitise” prostate cancer cells that were otherwise becoming resistant to standard treatment. 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).
If you think this trial might be right for you, please ask your doctor.
If you think this trial might be right for you, please ask your doctor.
Trial Title
Working Out M0 Bipolar Androgen Therapy (WOMBAT)
Cancer Type
Prostate
Trial Status
Recruiting
Protocol Number
ANZUP 2201
Study Chair
Prof Anthony Joshua (Study Chair) and Dr. Megan Crumbaker (Co-study Chair)
Study Objective

To determine the utility of the addition of bipolar androgen therapy (BAT) to intermittent darolutamide upon PSA progression on darolutamide alone for nmCRPC as measured by metastasis free survival (time from commencing BAT to evidence of metastasis or death) and to determine if this treatment is worthy of further study.

Patient Population
WOMBAT will recruit adults with M0 castrate resistant prostate cancer with PSA progression but not radiological progression on darolutamide (as per conventional imaging criteria)
Primary Outcome

To determine the metastasis free survival (time from commencing BAT to evidence of metastasis or death) (as per RECIST 1.1 or PCWG3 criteria)

Recruitment Target
69 participants
Acknowledgements
The WOMBAT trial is an investigator-initiated trial sponsored and led by ANZUP. This trial has received funding from Bayer. This trial is a collaboration between ANZUP and The George Institute for Global Health.
Detailed Information
Participating Centres
NSW
Sydney Adventist Hospital
GenesisCare Northern Cancer Institute St Leonard's

SA
Royal Adelaide Hospital - Central Adelaide Local Health Network Inc.