Author:

Keywords:

Adenocarcinoma of the prostate, Degarelix, Gonadotropin-releasing hormone, GnRH antagonist, GnRH blocker, Prostate cancer, Prostate-specific antigen, Testosterone, Science & Technology, Life Sciences & Biomedicine, Urology & Nephrology, OPEN-LABEL, SUSTAINED-RELEASE, LHRH AGONISTS, ANTAGONIST, TESTOSTERONE, ABARELIX, MICROPARTICLES, LEUPROLIDE, GOSERELIN, ANALOG, Aged, Aged, 80 and over, Chromobox Protein Homolog 5, Humans, Male, Middle Aged, Oligopeptides, Prostatic Neoplasms, Receptors, LHRH, Time Factors, 1103 Clinical Sciences, 3202 Clinical sciences

Abstract:

BACKGROUND: Degarelix is a gonadotropin-releasing hormone antagonist (GnRH receptor blocker) with immediate onset of action, suppressing gonadotropins, testosterone, and prostate-specific antigen (PSA) in prostate cancer. OBJECTIVE: To determine the efficacy and safety of initial doses of 200mg or 240mg of degarelix and thereafter monthly subcutaneous maintenance doses of 80mg, 120mg, or 160mg of degarelix for the treatment of prostate cancer. DESIGN, SETTING, AND PARTICIPANTS: The 1-yr study was of open-label, randomised design and involved 187 patients (range: 52-93 yr, median: 72 yr) with histologically confirmed adenocarcinoma of the prostate and a baseline PSA >2ng/ml. RESULTS AND LIMITATIONS: At baseline, median serum testosterone was 4.13ng/ml (range: P25-P75, 3.37-5.19ng/ml) and PSA was 27.6ng/ml (range: P25-P75, 11.9-55.0ng/ml). On day 3, 88% and 92% of patients in the groups to whom 200-mg and 240-mg initial doses of degarelix were administered, respectively, had testosterone levels