High-Risk Biochemically Relapsed Prostate Cancer Treatment Study
The purpose of this study is to study androgen annihilation in high-risk biochemically relapsed prostate cancer and to collect data.
In order to participate you must meet the following criteria:
- Have histologically confirmed prostate adenocarcinoma.
- Have had prior radical prostatectomy.
- Have biochemically recurrent prostate cancer with PSA doubling time ≤ 9 months at the time of study entry. Calculation of PSA doubling time should include the use of all available PSA values obtained within past 12 months prior to randomization, with a minimum of 3 values separated by at least 2 weeks apart. PSA values obtained prior to localized therapy will be excluded. PSA doubling time to be estimated using Memorial Sloan Kettering Cancer Center online calculator.
- Have had prior adjuvant or salvage radiation or are not a candidate for radiation based upon clinical assessment of disease characteristics and patient co-morbidities.
You will be excluded from the study if any of the following criteria apply to you:
- Have had prior androgen deprivation therapy (ADT) and/or first generation anti-androgen (e.g. bicalutamide, nilutamide, flutamide) for biochemically recurrent prostate cancer. Prior ADT and/or first generation anti-androgen in the (neo)adjuvant and/or salvage setting before, during, and/or following radiation or surgery is allowed provided last effective dose of ADT and/or first-generation anti-androgen is > 9 months prior to date of randomization and total duration of prior therapy is ≤ 36 months.
- Have had prior treatment with CYP17 inhibitor (e.g. ketoconazole, abiraterone acetate, galeterone) or second generation androgen receptor antagonist including apalutamide or enzalutamide.
- Have had prior chemotherapy for prostate cancer except if administered in neoadjuvant or adjuvant setting.
- Have used a 5-alpha reductase inhibitor within 42 days prior to randomization.
This is a partial list of inclusion and exclusion criteria.