A Phase III Protocol of Androgen Suppression (AS) and Radiation Therapy (RT) vs AS and RT Followed by Chemotherapy With Paclitaxel, Estramustine, and Etoposide (TEE) for Localized, High-Risk, Prostate Cancer

Trial Information

A Phase III Protocol of Androgen Suppression (AS) and Radiation Therapy (RT) vs AS and RT Followed by Chemotherapy With Paclitaxel, Estramustine, and Etoposide (TEE) for Localized, High-Risk, Prostate Cancer

OBJECTIVES:

- Compare the efficacy of androgen suppression and radiotherapy with or without
subsequent paclitaxel, estramustine, and etoposide, in terms of overall and
disease-free survival, biochemical and local control, and freedom from distant
metastasis, in patients with localized high-risk prostate cancer.

- Compare the toxic effects of these regimens in these patients.

OUTLINE: This is a randomized study. Patients are stratified according to prostate-specific
antigen level (≤ 10 ng/mL vs 11-100 ng/mL), tumor stage (T1-2 vs T3-4), Gleason score (7 vs
8-10), and prior hormone use (yes vs no). Patients are randomized to one of two treatment
arms.

All patients receive androgen suppression comprising a luteinizing hormone-releasing hormone
(LHRH) agonist AND bicalutamide OR flutamide for 4 months. Beginning 8 weeks after the
initiation of androgen suppression, all patients undergo radiotherapy once daily, 5 days a
week, for 7-8 weeks. Patients who received prior androgen suppression therapy count time to
radiotherapy from start date of prior hormonal therapy.

- Arm I: Patients continue androgen suppression therapy (LHRH agonist only) for
approximately 20 more months after radiotherapy is completed.

- Arm II: Patients continue therapy as in arm I and receive chemotherapy beginning 28
days after completing radiotherapy. Chemotherapy comprises oral estramustine 3 times
daily and oral etoposide twice daily on days 1-14 and paclitaxel IV over 1 hour on day
2. Chemotherapy repeats every 21 days for 4 courses.

Patients are followed every 3 months for 2 years, every 6 months for 3 years, and then
annually thereafter.

PROJECTED ACCRUAL: A total of 1,440 patients will be accrued for this study within 6 years.