Trial Information

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

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.