NCT00003026

Hormone Therapy in Treating Patients With Advanced Prostate Cancer

Long Term Adjuvant Hormonal Treatment With LHRH Analogue Versus No Further Treatment in Locally Advanced Prostatic Carcinoma Treated by External Irradiation and a Six Months Combined Androgen Blockade - A Phase III Study

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 966 (estimated)
• Sponsor: European Organisation for Research and Treatment of Cancer - EORTC · Network
• Sex: All
• Age: —
• Healthy volunteers: Not accepted

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.

Conditions

• Prostate Cancer

Interventions

Type	Name	Description
DRUG	bicalutamide
DRUG	flutamide
DRUG	triptorelin
RADIATION	radiation therapy

Timeline

• Start date: 1997-04-01
• Primary completion: 2001-09-01
• First posted: 2003-01-27
• Last updated: 2012-07-02

Locations

17 sites across 7 countries: Belgium, Israel, Malta, Netherlands, Russia, Turkey (Türkiye), United Kingdom