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A randomized, controlled phase III global trial comparing sipuleucel-T plus androgen deprivation therapy versus androgen deprivation therapy alone in men with metastatic androgen dependent (hormone sensitive) prostate cancer.

TPS188 Background: Prostate cancer is the most common cancer and the second leading cause of cancer deaths among men in North America and Western Europe. In Europe and North America between 10-25% and in Asia between 20-35% of all patients present and/or develop metastatic androgen dependent prostate cancer (mADPC). Androgen deprivation therapy (ADT) is the standard of care to treat men diagnosed with metastatic prostate cancer. Recently, sipuleucel-T was approved by the U.S. FDA for treatment of patients with asymptomatic or minimally symptomatic metastatic castrate resistant (hormone refractory) prostate cancer, based on a 4.1 month median survival benefit in a randomized, double blinded phase III study (IMPACT). The following proposed clinical trial is designed to evaluate the efficacy of sipuleucel-T in the mADPC patient population.


METHODS
Patients, diagnosed with metastatic androgen-dependent (hormone sensitive) prostate cancer (n=1684), will be enrolled in a global, randomized, open-label, multicenter trial. Patients will receive ADT to achieve castration-level testosterone and then will be randomized 1:1 to receive sipuleucel-T or continue on ADT alone. Primary endpoint of this study is overall survival. Secondary endpoints are safety, quality of life, time to castration resistance, and chemotherapy-free survival. Castration resistance will be determined by the Prostate Cancer Working Group 2 guidelines. From a subset of the study subpopulation (n=600), pharmacodynamic measures will be evaluated including serum and blood samples for cellular and humoral immune response analyses as well as circulating tumor cells (CTC). This trial will evaluate the therapeutic efficacy of sipuleucel-T in patients with mADPC while also expanding our understanding of the immunological response and clinical benefits of sipuleucel-T.