Trial Information

Multicentre Randomized Trial Assessing the Efficacy of a Short Neoadjuvant and Concomitant Hormone Therapy to an Exclusive Curative Cornformational Radiotherapy of Locolized Prostate Cancer With Intermediate Prognosis

OBJECTIVES:

- Compare the impact of neoadjuvant androgen blockade therapy comprising triptorelin and
flutamide followed by conformal external beam radiotherapy and continued androgen
blockage therapy vs conformal external beam radiotherapy alone in patients with stage
II or III prostate cancer.

- Compare the survival rate, in terms of 5-year clinical or biological remission, in
patients treated with these regimens.

- Compare overall survival in patients treated with these regimens.

- Compare acute and late toxicity of these regimens in these patients.

- Compare quality of life of patients treated with these regimens.

- Determine the value and time-delay to obtain prostate-specific antigen nadir in
patients treated with external beam radiotherapy alone.

OUTLINE: This is a randomized, multicenter study. Patients are randomized to 1 of 2
treatment arms.

- Arm I: Patients undergo conformal external beam radiotherapy.

- Arm II: Patients receive androgen blockade therapy comprising triptorelin
subcutaneously every 4 weeks and oral flutamide once daily. Androgen blockade therapy
continues for a total of 4 months. Two months after initiation of androgen blockade
therapy, patients undergo conformal external beam radiotherapy.

Quality of life is assessed.

PROJECTED ACCRUAL: A total of 450 patients will be accrued for this study.