MedTrace Logo

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

NCT02085252 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 116

Last updated 2019-06-28

Study results available
· View outcomes & findings →

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.

Conditions

Interventions

DRUG

Leuprorelin

Solution for injection

DRUG

Bicalutamide

Bicalutamide tablets

Sponsors & Collaborators

Principal Investigators

  • Medical Director Clinical Science · Takeda

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
50 Years
Max Age
80 Years
Sex
MALE
Healthy Volunteers
No

Timeline & Regulatory

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

Countries

  • France

Study Locations

More Related Trials

Entities

Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02085252 on ClinicalTrials.gov