Efficacy of degarelix in prostate cancer patients following failure on luteinizing hormone-releasing hormone agonist treatment: results from an open-label, multicentre, uncontrolled, phase II trial (CS27). (June 2015)

• Record Type: Journal Article
• Authors: Miller, Kurt; Simson, Gabriele; Goble, Sandra; Persson, Bo-Eric
• Is Part Of: Therapeutic advances in urology. Volume 7:Number 3(2015:Jun.)
• Page Start: 105
• Page End: 115
• Publication Date: 2015-06
• Subjects: degarelix -- luteinizing hormone-releasing hormone agonist -- prostate cancer; Urology -- Periodicals; Urologic Diseases -- therapy -- Periodicals; Genital Diseases, Male -- therapy -- Periodicals; Urologie -- Périodiques; 616.6005
• DOI: 10.1177/1756287215574479
• Languages: English
• ISSNs: 1756-2872

Abstract

Objective: To evaluate the efficacy of second-line degarelix in patients with prostate cancer (PCa) after treatment failure with a luteinizing hormone-releasing hormone (LHRH) agonist. Methods: This 1-year exploratory, multicentre, open-label phase II trial was performed in 2 patient cohorts (Cohort 1, n = 25; Cohort 2, n = 12) in Germany. Patients with castrate-resistant PCa after primary hormonal treatment received degarelix 240 mg, followed by 11 monthly maintenance doses of 80 mg. The primary endpoint was the proportion of patients with decreasing/stable prostate-specific antigen (PSA) (relative change ⩽+10% of baseline PSA) after 3 months. Results: At Month 3, the response rate (intention-to-treat, last observation carried forward analysis) was 16.7% [95% confidence interval (CI): 4.74–37.38] in Cohort 1 and 33.3% (95% CI: 9.92–65.11) in Cohort 2. The probability of completing 12 months without PSA progression was 8.8% (95% CI: 1.51–24.3) in Cohort 1 and 8.3% (95% CI: 0.5–31.1) in Cohort 2. Degarelix was well tolerated; the most frequently reported adverse events were local injection-site reactions. Conclusions: In PCa patients who failed LHRH therapy, degarelix was well tolerated and achieved a limited PSA response. Phase III trials show that disease control benefits with degarelix versus agonists are more clearly demonstrated as first-line therapy.