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The bicalutamide Early Prostate Cancer Program. Demography

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Reviewers: Li Liu, MD
Abramson Cancer Center of the University of Pennsylvania
Last Modified: November 1, 2001

Authors: See WA, McLeod D, Iversen P, et al.
Source: Urol. Oncol. 2001 Mar; 6(2): 43-47

Introduction

It has been well established that addition of adjuvant hormonal therapy to local definitive therapy significantly improves local tumor control, disease-free survival, and overall survival in patients with locally advanced adenocarcinomas of the prostate (Int J Radiat Oncol Biol Phys 2001 Mar 15; 49(4): 937-46; N Engl J Med 1997 Jul 31;337(5):295-300). However, the use of hormone therapy in patients with early stage prostate cancer remains undefined. In this study, the researchers reported demographic data of 3 randomized, double-blind, placebo-controlled trials evaluating whether the addition of bicalutamide (Casodex) is beneficial in patients with localized prostate cancer.

Method

• A total of 8113 patients from 23 countries with localized prostate cancer were included.
• Patients were randomized to receive Casodex 150 mg daily or placebo.
• Patients will remain on the treatment for 2-5 years depending on the site of enrollment.
• Patients are routinely evaluated with clinical exams, PSA blood tests, and bone scans.

Results

• Approximately two-thirds of the patients had localized disease (T1-2) and low Gleason Score (? 6).
• Less than 3% patients had node positive disease.
• Approximately 72% of the patients received definitive local therapy and the remainder received watchful waiting approach.

Discussion

These are the largest randomized clinical trials of Casodex for patients with localized prostate cancer. These studies were designed to find out whether the addition of Casodex 150 mg to standard care reduces the risk of disease progression and improves survival. The final results of these studies are anxiously awaited so the important question of hormonal use in early stage prostate cancer is definitively answered.