A Selective Androgen Receptor Modulator (OPK-88004) in Prostate Cancer Survivors: A Randomized Trial.

摘要: BACKGROUND Androgen deficiency is common among prostate cancer survivors, but many guidelines consider history of a contraindication for testosterone replacement. We determined the safety and efficacy selective androgen receptor modulator (OPK-88004) in symptomatic, testosterone-deficient men who had undergone radical prostatectomy low grade, organ-confined cancer. METHODS In this placebo-controlled, randomized, double-blind trial, 114 men, >19 years, organ-localized cancer, undetectable PSA ( 2 years after were randomized stages to placebo or 1, 5 15 mg OPK-88004 daily 12-weeks. Outcomes included recurrence, sexual activity, desire, erectile function, body composition, muscle strength physical function measures, mood, fatigue bone markers. RESULTS Participants on average 67.5-years severe dysfunction (mean desire domain scores 7.3, 14.6, respectively). No participant experienced recurrence erythrocytosis. was associated with dose-related increase whole (P<0.001) appendicular lean mass significantly greater decrease percent fat (p<0.001) serum alkaline phosphatase than placebo. Changes fatigue, performance, markers did not differ groups (p=0.73). CONCLUSIONS Administration OPK-8804 safe androgen-deficient increased decreased mass, improve symptoms performance.