The COSMYC Trial for Metastatic Castration-resistant Prostate Cancer
This study is looking for men with prostate cancer that has spread (metastatic) and is no longer responding to hormone therapy (castration-resistant). Researchers want to see if a combination of ZEN-3694 and testosterone cypionate (called BATZEN), followed by ZEN-3694 and enzalutamide (called ZENZA), can shrink tumors. They also want to know if starting with BATZEN makes the ZENZA combination work better. You would need to have prostate cancer confirmed by a biopsy and be on continuous hormone therapy. The study aims to measure how long you live without your cancer getting worse (progression-free survival) over two years.
- Study design
- This is an interventional study planning to enroll 50 participants. It is an open-label study, meaning both you and your doctors will know which treatments you are receiving.
- What's involved
- Not specified in the trial record.
- Compensation
- Not stated in the trial record.
- Follow-up
- The primary goals of the study are measured at 2 years, suggesting follow-up for at least that long.
AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.
The COSMYC Trial (COmbined Suppression of MYC)
At a glance
Conditions
Where it's being run
1 sites across 1 statesStudy leadership
- Samuel Denmeade, MD · PRINCIPAL_INVESTIGATOR · Johns Hopkins University
Who to contact
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What this trial measures
- Clinical/radiographic progression free survival (PFS) with BATZEN2 years
Median time from the first date of BATZEN to the date of first documented radiological progression per RECIST 1.1 for soft tissue or per Prostate Cancer Working Group 3 (PCWG3) for bone lesions, the development of symptoms or complications attributable to cancer progression, or death, whichever occurs first.
- Prostate specific antigen (PSA)-Progression free survival (PFS) with ZENZA2 years
PSA-PFS on ZENZA is the median time from start of ZENZA to time of PSA progression according to PCWG3 criteria ,or censored at the last date of PSA assessment for patients without PSA progression.