A031201: Phase III Trial of Enzalutamide versus Enzalutamide, Abiraterone and Prednisone For Castration Resistant Metastatic Prostate Cancer
Cancer Genitourinary/ Prostate
- Progressive castration-resistant metastatic prostate cancer with histologically or cytologically confirmed adenocarcinoma of the prostate without neuroendocrine differentiation or small cell features;
- Patients must have progressive disease at study entry defined as one or more of the following three criteria that occurred while the patient was on androgen deprivation therapy.
- PSA progression defined by a minimum of two rising PSA levels with an interval of = 1 week between each determination. Patients who received an anti-androgen must have progression documented by a minimum of two rising PSA levels with an interval of = 1 week between each determination such that at least the second of these rises is = 4 weeks since last flutamide or = 6 weeks since last bicalutamide or nilutamide. The PSA value at the screening should be = 2 µg/L (2 ng/mL)?
- Soft tissue disease progression defined by the protocol
- Bone disease progression defined by the Prostate Cancer Working Group 2 (PCWG2) with two or more new lesions on bone scan.