1. ¹Technical University of Dresden Medical School, Dresden, Germany
2. ²Plymouth Oncology Centre, Derriford Hospital, Plymouth, UK
3. ³Atrium Medical Centre, Heerlen, The Netherlands
4. ⁴Hospital Principe de Asturias, Alcala de Henares, Madrid, Spain
5. ⁵Department of Urology, Chaim Sheba Medical Center, Tel-Hashomer, Israel
6. ⁶Queen Elizabeth Medical Centre, Edgbaston, Birmingham, UK
7. ⁷Princess Royal Hospital, Hull, UK
8. ⁸Servico de Urologica, Hospital de São Joao, Porto, Portugal
9. ⁹Tygerberg Hospital and Faculty of Health Sciences, University of Stellenbosch, Cape Town, South Africa
10. ¹⁰AstraZeneca, Macclesfield, UK

Correspondence: M Wirth, Department of Urology, Technical University of Dresden Medical School, Fetscherstrasse 74, Dresden D-01307, Germany. E-mail: wirth-m@rcs.urz.tu-dresden.de

Received 1 March 2005; Accepted 23 March 2005.

Abstract

Trial 24 is one of three placebo-controlled trials within the ongoing bicalutamide ('Casodex'^†) Early Prostate Cancer (EPC) programme evaluating bicalutamide 150 mg/day in addition to radical prostatectomy, radiotherapy or watchful waiting for T1b–4, any N, M0 prostate cancer. In Trial 24, at 5.1 y median follow-up, the addition of bicalutamide significantly (P<0.0001) improved objective progression-free survival (PFS) and prostate-specific antigen PFS compared with standard care alone. There was no significant difference in overall survival (P=0.746). In the context of the whole EPC programme, long-term bicalutamide is not appropriate for localised disease, yet provides advantages in delaying disease progression in patients with locally advanced prostate cancer.