drugset / Trial / 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.

NCT01753297

Phase 4 Completed 226 enrolled Ipsen
RandomizedParallel-groupOpen-labelTreatment

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

Timeline

Start
2012-12-11
Primary completion
2019-09-09
Completion
2019-09-09

Drugs

EvaluationDrugModalityDoseRoute
Comparator Triptorelin Other / unclassified 11.25 mg

Indications