NCT01819285

Early Compared With Delayed Hormone Therapy in Treating Patients With Nonmetastatic Prostate Cancer

Phase III Comparison of Early vs Delayed Endocrine Manipulation (Orchiectomy or LHRH Agonist Therapy) in Previously Untreated Patients With Nonmetastatic Asymptomatic Carcinoma of the Prostate

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 985 (actual)
• Sponsor: European Organisation for Research and Treatment of Cancer - EORTC · Network
• Sex: Male
• Age: 80 Years
• Healthy volunteers: Not accepted

Summary

Objectives I. Compare, in a randomized Phase III multi-institutional setting, symptom-free survival time of patients with asymptomatic carcinoma of the prostate (T0-4, N0-2, M0) not suited for local curative treatment who are randomly assigned to immediate vs. delayed endocrine intervention (orchiectomy or luteinizing hormone releasing hormone (LHRH) agonist therapy). II. Compare the overall survival of these two groups of patients. III. Compare the time to first evidence of distant progression (N4 or M1) of these two treatment groups. IV. Evaluate the prognostic significance of pretreatment laboratory data and monitor these parameters following endocrine therapy. V. Study the prognosis of various sub-groups of patients stratified according to performance status, local tumor extent, nodal status, and choice of endocrine treatment.

Conditions

• Neoplasm, Prostate

Interventions

Type	Name	Description
PROCEDURE	Immediate Orchiectomy or depot LHRH
PROCEDURE	Delayed Orchiectomy or depot LHRH

Timeline

• Start date: 1990-02-01
• Primary completion: 2004-07-01
• Completion: 2010-09-01
• First posted: 2013-03-27
• Last updated: 2013-03-27