Trial Information

A Randomised Comparison of Short and Protracted Neoadjuvant Hormonal Therapy Prior to Radiation Therapy of High Risk Localized Prostate Cancer

OBJECTIVES: I. Compare the efficacy of 4 months vs 8 months of luteinizing hormone-releasing
hormone (LHRH) agonist therapy combined with antiandrogen therapy prior to radiotherapy, in
terms of disease-free survival and overall survival, in patients with stage I-IV localized
invasive prostate cancer.

OUTLINE: This is a randomized study. Patients are randomized to one of two treatment arms.
All patients receive triptorelin IM once a month and oral flutamide three times daily with
meals. Patients randomized to arm I receive this therapy regimen for 4 months. Patients
randomized to arm II receive this therapy regimen for 8 months. All patients then undergo
radiotherapy 5 days a week for 7 weeks within 2 months of the last injection of triptorelin
and within 1 month of the last oral flutamide tablet. Patients are followed every 3 months
after radiotherapy.

PROJECTED ACCRUAL: A total of 276 patients (138 per treatment arm) will be accrued for this
study.