Phase II Trial of Maximal Androgen Deprivation Followed by Conformal External Beam Radiotherapy With Continued Androgen Deprivation for Clinically Localized Prostate Cancer
- Assess the disease free survival of patients with localized adenocarcinoma of the
- Evaluate the toxic effects of three dimensional conformal external beam radiotherapy
and androgen deprivation in these patients.
OUTLINE: Patients are stratified according to PSA values and Gleason scores (class II versus
Patients receive intramuscular leuprolide acetate every 3 months, and oral flutamide tid.
Patients are evaluated on a monthly basis for response. Patients with unchanged or
undetectable prostate specific antigen levels are considered to have reached maximal
hormonal response and three dimensional conformal external beam radiotherapy is instituted.
In addition, patients with disease progression are considered to have reached maximal
response, and three dimensional conformal external beam radiotherapy is instituted.
Radiotherapy must be administered within 6 months after initiation of leuprolide and
Hormonal therapy is administered until 9 months of treatment have elapsed.
Patients will be followed every 3 months for the first year, every 4 months for the second
and third years, and every 6 months thereafter.
PROJECTED ACCRUAL: A total of 105 patients will be accrued from biologic class II over 3
years, and 58 patients from biologic class III-IV.
Primary Purpose: Treatment
Ronald D. Ennis, MD
Herbert Irving Comprehensive Cancer Center
United States: Federal Government
|Herbert Irving Comprehensive Cancer Center||New York, New York 10032|