Phase III Randomized Study of Adjuvant Therapy for High Risk pT3N0 Prostate Cancer
- Compare the overall survival, disease-free survival, freedom from distant metastases,
and freedom from PSA failure in patients with high-risk stage II or III prostate cancer
treated in the adjuvant setting with radiotherapy and hormonal therapy vs radiotherapy
- Compare the qualitative and quantitative toxic effects of these regimens in these
OUTLINE: This is a randomized, multicenter study. Patients are stratified according to
seminal vesicle invasion (yes vs no), preoperative PSA (10 ng/mL or less vs greater than 10
ng/mL), Gleason score (2-6 vs 7 vs 8-10), positive surgical margins (yes vs no), and
neoadjuvant hormonal therapy (yes vs no). Patients are randomized to 1 of 3 treatment arms.
(Arm III closed to accrual as of 12/9/2002.)
- Arm I: Patients undergo radiotherapy once daily 5 days a week for 7 weeks. Beginning
the first day of radiotherapy, patients also receive hormonal therapy comprising a
luteinizing-hormone-releasing hormone agonist once every 1-4 months for 2 years AND
oral flutamide 3 times daily OR oral bicalutamide once daily for 1 month.
- Arm II: Patients undergo radiotherapy as in arm I.
- Arm III (Closed to accrual as of 12/9/2002):Patients receive hormonal therapy as in arm
Patients are followed every 3 months for 1 year, every 6 months for 4 years, and then
PROJECTED ACCRUAL: A total of 1,398 patients (699 per treatment arm) will be accrued for
this study within 5 years. (Arm III closed to accrual as of 12/9/2002.)
Allocation: Randomized, Primary Purpose: Treatment
Richard K. Valicenti, MD
Kimmel Cancer Center (KCC)
United States: Federal Government