Efficacy and Safety of a Triptorelin 6-month Formulation in Patients With Advanced Prostate Cancer
Efficacy and safety of a triptorelin 6-month formulation in patients with advanced prostate cancer. It was assumed that during the study treatment >90% of the patients would achieve and maintain castrate levels of serum testosterone.
|Study Design:||Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||A Multicenter, Open, Non-comparative, Phase III Study on the Efficacy, Pharmacokinetics and Safety of Two Injections of Triptorelin Embonate 22.5 mg 6-month Formulation in Patients With Advanced Prostate Cancer.|
- Achievement of Castration and Maintenance of Castration [ Time Frame: at Day 29 ] [ Designated as safety issue: No ]Percentage of patients achieving castrate testosterone levels (≤1.735 nmol/L) by Day 29 (28 days after study drug injection) and percentage of patients maintaining castrate testosterone levels from Month 2 to end of Month 12 (Week 48).
- LH Increase [ Time Frame: day 1 and day 169 ] [ Designated as safety issue: No ]% of patients showing ≤1.0 IU/L increase in s-LH from 0 to 2 h after 1st & 2nd injection.% changes in PSA throughout treatment.% of 60 pts with s-testosterone levels >1.735 nmol/L after 2nd injection.Testosterone PD and triptorelin PK metrics in 15 pts
|Study Start Date:||July 2006|
|Study Completion Date:||August 2007|
|Primary Completion Date:||August 2007 (Final data collection date for primary outcome measure)|
Drug: triptorelin embonate (INN)
Triptorelin embonate 22.5 mg 6 month formulation to be injected every 24 weeks
Efficacy of triptorelin treatment on gonadotropin (LH) stimulation from hypophysis, as well as on the PSA (prostate specific antigen) levels and safety laboratory parameters. The triptorelin pharmacokinetics and testosterone pharmacodynamics were assessed in a subset of 15 patients.