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Leuprorelin Associated With Radiotherapy Versus Leuprorelin Alone in T3 - T4 or pT3 (on Biopsy) N0, M0 Prostate Cancer

NCT01122121 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 273

Last updated 2015-07-29

No results posted yet for this study

Summary

The purpose of this study is to compare the efficacy and safety of combined radiotherapy and hormone therapy and hormone therapy alone in the treatment of clinically locally advanced prostate cancer (T3-T4 or pT3 on biopsy, N0, M0).

Conditions

  • Prostatic Neoplasms, Locally Advanced

Interventions

DRUG

Leuprorelin SR

Leuprorelin SR injection

RADIATION

Radiotherapy

Radiotherapy 70 +/- 4 Gy

DRUG

Flutamide

Flutamide tablets

Sponsors & Collaborators

Principal Investigators

  • Nicolas MOTTET, Dr · Clinique Mutualiste - Saint-Etienne

  • Pierre RICHAUD, Dr · Institut BERGONIÉ, Centre Régional de Lutte contre le Cancer, Bordeaux

  • Michel PENEAU, Dr · Martinique

  • Jean-Jacques MAZERON, Pr · Groupe Hospitalier PITIE-SALPETRIERE, Paris

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2000-03-31
Primary Completion
2008-12-31
Completion
2009-06-30

Countries

  • France

Study Locations

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Entities

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 NCT01122121 on ClinicalTrials.gov