A Randomized, Open-Label, Phase 2 Trial Of Sipuleucel-T With Concurrent Versus Sequential Administration Of Abiraterone Acetate Plus Prednisone In Men With Metastatic Castrate Resistant Prostate Cancer
ID Number 12-0634Principal Investigator(s)
Simon J. Hall
Department(s) or Division(s)
This Phase II study will examine the impact of administration of sipuleucel-T followed by abiraterone plus prednisone versus administration of both therapies at the same time for men with minimally symptomatic castrate resistant metastatic prostate cancer. This study is important in examining the effect of prednisone on the immune system's ability to take up sipuleucel-t and make it an active therapy. All subjects will be scheduled to receive three infusions of sipuleucel-T as well as a total of 26 weeks of therapy with abiraterone acetate plus prednisone either concurrently with or following administration of sipuleucel-T. All subjects will be followed for 3 years from registration/randomization, with an anticipated 6-month enrollment period.
Cynthia Knauer RN, CRC
Recruiting Patients: No