A phase 2, randomized, 3-arm study of abiraterone acetate alone, abiraterone acetate plus degarelix, a GnRH antagonist, and degarelix alone for patients with prostate cancer with a rising PSA or a rising PSA and nodal disease following definitive radical prostatectomy (PCCTC LOI#c11-092)
Johns Hopkins Kimmel Cancer Center in Baltimore
Sibley Memorial Hospital
This research is being done to evaluate abiraterone acetate and prednisone in combination with degarelix (a gonadotropin-releasing hormone antagonist), as a possible treatment for prostate specific antigen (PSA) recurrent prostate cancer as compared to abiraterone acetate alone and degarelix alone. This will be the first time these drugs will be used together.
Must be 18 years of age or older, must have undergone a radical prostatectomy, must have achieved an undetectable PSA after radical prostatectomy, must have confirmed prostate cancer with progressive disease with rising PSA and a PSA doubling time of less than/or equal to 9 months OR rising PSA and metastatic disease limited to the presence of pelvic and/or retroperitoneal nodes less than 2cm, must be in good physical shape, must have good blood/kidney/liver function, able to swallow a large pill whole, able to take a pill on an empty stomach, must not have received any prior chemotherapy or hormonal therapy, must not have any known brain metastasis or other metastasis other than mentioned as allowable, cannot have uncontrolled hypertension.
Patient will be assigned to 1 of 3 groups: Group 1 will receive Abiraterone acetate and predinisone, Group 2 will receive Abiraterone acetate plus degarelix and prednisione, Group 3 will receive Degarelix alone. Abiraterone is an oral pill that is taken once daily either 1 hour before a meal or 2 hours after a meal. The dose will be 1000 mg which will be given as four 250 mg tablets. These patients will also receive prednisone 5 mg once daily to be taken with food. Patients who are assigned to receive Degarelix will be given 2 subcutaneous shots of 120 mg each on the 1st day of the first cycle and then a single shot of 80 mg every 28 days (1 cycles). Each cycle is 28 days long (4 weeks). Treatment may last for 8 cycles (32 weeks). For patients receiving abiraterone acetate, a follow-up visit on day 15 of cycles 1/2/3 must be done. Otherwise, visits are only every cycle once on study treatment. PSA's will be done at the beginning of every cycle.
05/25/2016 05:03 AM