drugset / Trial / NCT02085252

A Study of the Effect of Enantone LP 11.25 mg (Leuprorelin) on the Histological Progression of Indolent Prostate Cancer

NCT02085252

Phase 3 Completed 116 enrolled Takeda
RandomizedParallel-groupOpen-labelTreatment

Summary

The purpose of this study is to assess two treatment strategies (leuprorelin treatment and active surveillance without androgen deprivation) for indolent prostate cancer and to compare their therapeutic benefit for management of patients with low-risk, localized prostate cancer.

Timeline

Start
2013-06-03
Primary completion
2016-11-08
Completion
2016-11-08

Drugs

EvaluationDrugModalityDoseRoute
Subject Leuprolide Other / unclassified 11.25 mg Subcutaneous
Background Bicalutamide Other / unclassified 50 mg Oral

Indications