Decapeptyl triptorelin pamoate: Additional Phase III data

Additional data from a single-arm, open-label, European Phase III trial in patients with locally advanced or metastatic prostate cancer showed that a 3-month formulation of 11.25 mg subcutaneous Decapeptyl led to castration in 97.6% of men at week 4 and maintained castration in 96.6% of those men at week 26 -- both co-primary endpoints. The thresholds for meeting the endpoints were >80% achieving castration at week 4 and >85% maintaining castration at week 26. Castration was defined by testosterone levels of <50 ng/dL. Median time to castration was 22 days. Mean testosterone levels were reduced to 18.4 ng/dL at week 4 and 10.2 ng/dL at week 8 and remained within that range until the end of the trial. Median PSA levels were reduced by 64.2% at week 4 and 96% at week 26 and remained within the normal range (0-4 ng/mL) from week 8 until the end of the trial. Data were presented at the European Association of Urology meeting in Cracow, Poland. Ipsen previously reported that the trial met the co-primary endpoints (see BioCentury, Feb. 10). ...