NCT01753297

A Study of Immediate 9 Months Adjuvant Hormone Therapy With Triptorelin 11.25 mg Versus Active Surveillance After Radical Prostatectomy in High Risk Prostate Cancer Patients.

A Multicentric, Multinational (China and Russia), Randomised, Open, Controlled Study of Immediate 9 Months Adjuvant Hormone Therapy With Triptorelin 11.25 mg Versus Active Surveillance After Radical Prostatectomy in High Risk Prostate Cancer Patients

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 226 (actual)
• Sponsor: Ipsen · Industry
• Sex: Male
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to assess the benefit of immediate hormonal treatment after Radical Prostatectomy in Chinese and Russian patients with high risk prostate cancer. To reach this target, the trial will compare a group of patients treated with triptorelin at 8 weeks after the surgery and for a duration of 9 months (3 injections) versus another group (called "active surveillance group") who will be not receiving triptorelin. Both groups will be followed every 3 months to monitor any sign of disease progression during a minimum of 36 months

Detailed description

This trial is a phase IV (in Russia and China) as approved indication is locally advanced or metastatic prostate cancer in both countries.

Conditions

• Prostate Cancer

Interventions

Type	Name	Description
DRUG	Triptorelin 11.25 mg	Triptorelin, one injection every 3 months. A total of 3 injections (at baseline, 3 and 6 months)

Timeline

• Start date: 2012-12-11
• Primary completion: 2019-09-09
• Completion: 2019-09-09
• First posted: 2012-12-20
• Last updated: 2020-12-09
• Results posted: 2020-12-09

Locations

18 sites across 2 countries: China, Russia