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
This trial is a phase IV (in Russia and China) as approved indication is locally advanced or
metastatic prostate cancer in both countries.
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Biochemical Relapse-Free Survival (BRFS)
BRFS defined as period of time from randomisation to time of Biochemical Relapse (BR). BR is defined as increased prostate specific antigen (PSA) >0.2 ng/mL confirmed by a second measurement performed 4 to 6 weeks later
Every 3 months, up to 5 years
Patrick Cabri, M.D.
Russia: Ministry of Health of the Russian Federation