Phase I Study of 3-Dimensional Conformal Radiotherapy in Patients With Locally Advanced (Stage T2c and T3) Adenocarcinoma of the Prostate
OBJECTIVES: I. Determine the maximum tolerated dose of radiotherapy using 3-dimensional (3D)
conformal techniques in patients with stage II or III adenocarcinoma of the prostate. II.
Determine the morbidity of high-dose 3D conformal therapy in these patients.
OUTLINE: This is a dose escalation study. Patients undergo 3-dimensional conformal
radiotherapy 4-5 days a week for at least 8 weeks. Cohorts of 20-40 patients receive
escalating doses of radiotherapy until the maximum tolerated dose (MTD) is determined. The
MTD is defined as the dose at which no more than 10% of patients experience dose-limiting
toxicity. Patients are followed at 3 months, every 6 months for 5 years, and then annually
PROJECTED ACCRUAL: A minimum of 40 patients will be accrued for this study.
Primary Purpose: Treatment
Michael J. Zelefsky, MD
Memorial Sloan-Kettering Cancer Center
United States: Federal Government
|Memorial Sloan-Kettering Cancer Center||New York, New York 10021|