The Efficacy and Safety of Degarelix One Month Dosing Regimens in Prostate Cancer

Summary

The study was a three-arm, active-control, multi-centre, parallel group study.

Timeline

Start

2006-02

Primary completion

2007-10

Completion

2007-10

Outcome

Met primary endpoint

paper Degarelix was not inferior to leuprolide at maintaining low testosterone levels over a 1-year treatment period. PMID 19035858 ↗

paper This was achieved by 97.2%, 98.3% and 96.4% of patients in the degarelix 240/80 mg, degarelix 240/160 mg and leuprolide groups, respectively (ITT population). PMID 19035858 ↗

Publications

• Results Klotz L, Boccon-Gibod L, Shore ND, Andreou C, Persson BE, Cantor P, Jensen JK, Olesen TK, Schroder FH. The efficacy and safety of degarelix: a 12-month, comparative, randomized, open-label, parallel-group phase III study in patients with prostate cancer. BJU Int. 2008 Dec;102(11):1531-8. doi: 10.1111/j.1464-410X.2008.08183.x.
• Zengerling F, Jakob JJ, Schmidt S, Meerpohl JJ, Blumle A, Schmucker C, Mayer B, Kunath F. Degarelix for treating advanced hormone-sensitive prostate cancer. Cochrane Database Syst Rev. 2021 Aug 5;8(8):CD012548. doi: 10.1002/14651858.CD012548.pub2.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Degarelix	Other / unclassified	80 mg	Subcutaneous
Subject	Degarelix	Other / unclassified	160 mg	Subcutaneous
Comparator	Leuprolide	Other / unclassified	7.5 mg	Intramuscular

Indications