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  • Long-term tolerability and efficacy of degarelix: 5-year results from a phase III extension trial with a 1-arm crossover from leuprolide to degarelix.

Long-term tolerability and efficacy of degarelix: 5-year results from a phase III extension trial with a 1-arm crossover from leuprolide to degarelix.

Urology (2014-03-26)
E David Crawford, Neal D Shore, Judd W Moul, Bertrand Tombal, Fritz H Schröder, Kurt Miller, Laurent Boccon-Gibod, Anders Malmberg, Tine Kold Olesen, Bo-Eric Persson, Laurence Klotz
ABSTRACT

To demonstrate the safety and efficacy of up to 5 years of degarelix treatment and the effects of crossing over from leuprolide to degarelix in the extension phase of a phase III pivotal 1-year trial. Patients receiving degarelix who completed the 1-year trial continued on 80 mg (n = 125) or 160 mg (n = 126) maintenance doses. Patients who received leuprolide were rerandomized to degarelix 240/80 mg (n = 69) or 240/160 mg (n = 65). Safety and tolerability were assessed (primary end point), as well as testosterone and prostate-specific antigen levels and prostate-specific antigen progression-free survival (secondary end points). Adverse event frequency was similar between both the groups. Adverse events included initial injection site reactions, hot flushes, and increased weight. Testosterone and prostate-specific antigen values during the extension study were similar to those seen during the 1-year trial in patients who continued on degarelix or crossed over from leuprolide. The prostate-specific antigen progression-free survival hazard rate was decreased significantly after the crossover in the leuprolide to degarelix group (from 0.20 to 0.09; P = .002), whereas in patients who continued on degarelix, the rate did not change significantly. In patients with baseline prostate-specific antigen >20 ng/mL, the same hazard rate change pattern was observed on crossover (from 0.38 to 0.19; P = .019). Degarelix was well tolerated; no safety concerns were identified. The significant prostate-specific antigen progression-free survival benefit established for degarelix over leuprolide during year 1 remained consistent at 5 years.

MATERIALS
Product Number
Brand
Product Description

Sigma-Aldrich
Testosterone, ≥98%
Sigma-Aldrich
Leuprolide acetate salt, ≥98% (HPLC)
Supelco
Testosterone, VETRANAL®, analytical standard
Sigma-Aldrich
Testosterone, purum, ≥99.0% (HPLC)
Testosterone, European Pharmacopoeia (EP) Reference Standard
Supelco
Testosterone solution, 1.0 mg/mL in acetonitrile, ampule of 1 mL, certified reference material, Cerilliant®
Leuprorelin, European Pharmacopoeia (EP) Reference Standard