Hormone Therapy in Treating Patients With Advanced Prostate Cancer

Phase 3

Completed

• Conditions: Prostate Cancer

• Registration Number: NCT00003026
• Lead Sponsor: European Organisation for Research and Treatment of Cancer - EORTC

Brief Summary

RATIONALE: Androgens can stimulate the growth of prostate cancer cells. Hormone therapy using triptorelin may fight prostate cancer by reducing the production of androgens.

PURPOSE: Randomized phase III trial to compare the effectiveness of long-term hormone therapy and triptorelin with no further treatment in treating patients who have advanced prostate cancer previously treated with radiation therapy and 6 months of androgen suppression.

Detailed Description

OBJECTIVES:

* Determine the best hormonal scheme to be associated with pelvic radiotherapy in the curative management of prostatic carcinoma for hormonal treatment with regards to treatment outcome (overall survival, clinical disease free survival, local regional control), quality of life (treatment side effects, sexual function), and health economy (cost effectiveness ratio).

OUTLINE: This is a randomized, multicenter study.

Patients receive external radiation for 5 weeks, followed by a pelvic boost given for 2 weeks and a 6 month combined androgen blockage initiated at the onset of external irradiation. Flutamide (Eulexin) or bicalutamide (Casodex) may be used as the antiandrogens. Antiandrogen treatment starts 1 week before the first injection of triptorelin.

Patients are then randomized to one of two treatment arms.

* Arm I: Patients receive no further treatment.

* Arm II: Patients receive antiandrogen for 2.5 years plus and LHRH analogue (triptorelin) administered every 3 months. Patients then continue the LHRH analogue alone for an additional 2.5 years in the absence of disease progression.

Patients are followed every 6 months for 5 years and then annually thereafter.

PROJECTED ACCRUAL: A total of 966 patients will be accrued over 5 years.

Study Timeline

• Study Start: 1997-04
• Study First Submitted: 1999-11-01
• Primary Completion: 2001-09
• Study First Submitted QC: 2003-01-26
• Study First Posted: 2003-01-27
• Status Verified: 2012-06
• Last Update Submitted: 2012-06-29
• Last Update Posted: 2012-07-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 966

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: Not specified

Trial Locations

Locations (17)

St. Elisabeth Ziekenhuis; 🇳🇱 Tilburg, Netherlands

Academisch Ziekenhuis Groningen; 🇳🇱 Groningen, Netherlands

City General Hospital; 🇬🇧 Stoke-On-Trent, England, United Kingdom

Marmara University Hospital; 🇹🇷 Istanbul, Turkey

Institut Jules Bordet; 🇧🇪 Brussels (Bruxelles), Belgium

Academisch Ziekenhuis der Vrije Universiteit Brussel; 🇧🇪 Brussels, Belgium

Universitair Ziekenhuis Antwerpen; 🇧🇪 Edegem, Belgium

Virga Jesse Hospital; 🇧🇪 Hasselt, Belgium

Universitair Ziekenhuis Gent; 🇧🇪 Ghent, Belgium

U.Z. Gasthuisberg; 🇧🇪 Leuven, Belgium

St. Luke's Hospital and Medical School; 🇲🇹 Guardamangia, Malta

Groot Ziekengasthuis 's-Hertogenbosch; 🇳🇱 's-Hertogenbosch, Netherlands

Rambam Medical Center; 🇮🇱 Haifa, Israel

Onze Lieve Vrouwe Gasthuis; 🇳🇱 Amsterdam, Netherlands

Academisch Medisch Centrum; 🇳🇱 Amsterdam, Netherlands

Academisch Ziekenhuis Maastricht; 🇳🇱 Maastricht, Netherlands

Medical Radiological Research Center; 🇷🇺 Obninsk, Russian Federation