NCT01673984

GP Extended Action Triptorelin

A Phase IV, Randomised, Open-label, Multi-centre Study to Assess the Impact on Disease Control, Safety, Patient and Clinician Experience of Changing Patients With Advanced Prostate Cancer From a 3-monthly LHRH Agonist to 6-monthly Injections of Decapeptyl® SR 22.5 MG

• Status: Terminated
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 27 (actual)
• Sponsor: Ipsen · Industry
• Sex: Male
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to demonstrate that treatment with a 6-monthly injection of hormone therapy is as good and as well tolerated as the standard 3-monthly hormone therapy injections available for treating prostate cancer. The study will also aim to answer whether both doctors and patients would prefer treatment with a 6-monthly injection rather than injections every 3 months.

Conditions

• Prostate Cancer

Interventions

Type	Name	Description
DRUG	Decapeptyl® SR 22.5mg	22.5mg, intramuscular injection, given on day 1 / month 0 \& month 6 (+/- 7 days).
DRUG	Decapeptyl® SR 11.25mg; Prostap® 3 DCS 11.25mg; Zoladex® LA 10.8mg	For Decapeptyl® SR 11.25mg: 11.25 mg, intramuscular injection For Prostap® 3 DCS 11.25mg: 11.25mg, depot injected subcutaneously For Zoladex® LA 10.8mg: 10.8mg, depot injected subcutaneously into anterior abdominal wall

Timeline

• Start date: 2012-08-01
• Primary completion: 2014-02-01
• Completion: 2014-02-01
• First posted: 2012-08-28
• Last updated: 2025-05-23
• Results posted: 2015-09-29

Locations

35 sites across 1 country: United Kingdom