Radiation Therapy With or Without Bicalutamide and Goserelin in Treating Patients With Prostate Cancer

Prostate Cancer Clinical Trial

Official title: Phase III Randomized Trial Study Comparing the Outcome of High-Dose IMRT (86.4 GY) Alone With IMRT to 75.6 GY Plus Neoadjuvant/Adjuvant Androgen Deprivation in Patients With High Grade Intermediate Risk and Unfavorable Risk Prostate Cancer

Status Completed

Clinical Trial Summary

RATIONALE: Radiation therapy uses high-energy x-rays to damage tumor cells. Giving radiation therapy in different ways may cause less damage to normal tissue and may improve quality of life and help patients live more comfortably. Androgens can stimulate the growth of prostate cancer cells. Drugs such as goserelin and bicalutamide may fight cancer by stopping the production of androgens. It is not yet known whether radiation therapy is more effective with or without goserelin and bicalutamide in treating prostate cancer.

PURPOSE: Randomized phase III trial to compare the effectiveness of high-dose radiation therapy with or without bicalutamide and goserelin in treating patients who have prostate cancer.

Clinical Trial Description

OBJECTIVES:

• Compare the quality of life of patients with high-grade intermediate-risk or unfavorable-risk adenocarcinoma of the prostate when treated with high-dose intensity-modulated radiotherapy alone versus with androgen deprivation comprising bicalutamide and goserelin.

• Compare the prostate-specific antigen relapse-free, distant metastases-free, and overall survival of patients treated with these regimens.

• Compare the toxicity of these regimens in these patients.

• Compare the local control in patients treated with these regimens, based on post-treatment sextant biopsies performed 4 years after study completion.

OUTLINE: This is a randomized study. Patients are stratified according to prostate-specific antigen level, Gleason score, and clinical stage. Patients are randomized to 1 of 2 treatment arms.

• Arm I: Patients undergo high-dose intensity-modulated radiotherapy (IMRT) 4-5 times per week for 10 weeks (a total of 48 treatments).

• Arm II: Patients receive oral bicalutamide once daily for 18.5 weeks. Three to seven days after the initiation of bicalutamide, patients also receive goserelin subcutaneously monthly for 2 years. Beginning after 10 weeks of hormonal therapy, patients undergo concurrent high-dose IMRT 4-5 times per week for 8.5 weeks (a total of 42 treatments). Patients discontinue bicalutamide on or near the end of radiotherapy.

In both arms, treatment continues in the absence of disease progression or unacceptable toxicity.

Quality of life is assessed at baseline, every 3 months for 1.5 years after the completion of radiotherapy, then 6 months later, and then annually for 2 years.

Patients are followed every 6-8 months for 4 years and then annually for 2 years.

PROJECTED ACCRUAL: A total of 400 patients (200 per treatment arm) will be accrued for this study within 4-5 years. ;

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Prostate Cancer
• Prostatic Neoplasms

• NCT number: NCT00067015
• Study type: Interventional
• Source: Memorial Sloan Kettering Cancer Center
• Status: Completed
• Phase: Phase 3
• Start date: May 2003
• Completion date: September 2008