A031201: Phase III Trial of Enzalutamide versus Enzalutamide, Abiraterone and Prednisone For Castration Resistant Metastatic Prostate Cancer

8880-CTO
Cancer Genitourinary/ Prostate
Principal Investigator: Robert A Chapman, MD

This randomized phase III trial studies enzalutamide to see how well it works compared to enzalutamide, abiraterone acetate, and prednisone in treating patients with castration-resistant metastatic prostate cancer. Androgens can cause the growth of prostate cancer cells. Drugs, such as enzalutamide, abiraterone acetate, and prednisone, may lessen the amount of androgens made by the body.

  1. Progressive castration-resistant metastatic prostate cancer with histologically or cytologically confirmed adenocarcinoma of the prostate without neuroendocrine differentiation or small cell features;
  2. 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.
    1. 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)?
    2. Soft tissue disease progression defined by the protocol
    3. Bone disease progression defined by the Prostate Cancer Working Group 2 (PCWG2) with two or more new lesions on bone scan.
Open
Tiffany Pearce
(313) 916-1784