On October 10, 2014 Ipsen reported positive results from the phase III study of triptorelin pamoate 11.25 mg (Decapeptyl 3 months) administered subcutaneously in patients with locally advanced or metastatic prostate cancer at the European Association of Urology (EAU) 14th Central European Meeting in Cracow, Poland (10-12 October 2014) (Press release Ipsen, OCT 10, 2014, View Source [SID:1234500820]).

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The primary objective of the study was to assess the efficacy and safety profile of the sustained-release triptorelin pamoate 11.25 mg (Decapeptyl 3 months) formulation when administered by the subcutaneous route in men with locally advanced or metastatic prostate cancer. This objective was met with castration levels of testosterone achieved in 97.6% [95% CI: 93.2-99.5] of men at week 4 and castration maintained in 96.6% of these men [95% CI: 91.6-99.1] at week 26.

Mean testosterone levels decreased to 18.4 ng/dl and 10.2 ng/dl at week 4 and week 8,
respectively, and remained within this range until the end of the study. Median time to achieve
castration was 22 days. For more than 90% of the patients, the level of testosterone was
maintained below 20 ng/dl from week 8 up to the end of the trial.

Median Prostate Specific Antigen (PSA) levels were reduced by 64.2% and 96.0% at week 4
and week 26, respectively. PSA levels remained within the normal range (0–4 ng/ml) from week 8 until the end of the study.