Prostate Cancer Clinical Trial
Official title:
Phase II Trial of Maximal Androgen Deprivation Followed by Conformal External Beam Radiotherapy With Continued Androgen Deprivation for Clinically Localized Prostate Cancer
RATIONALE: Androgens can stimulate the growth of prostate cancer cells. Hormone therapy
using leuprolide and flutamide may fight prostate cancer by reducing the production of
androgens. Combining radiation therapy with hormone therapy may kill more tumor cells.
PURPOSE: Phase II trial to study the effectiveness of hormone therapy plus radiation therapy
in treating patients with prostate cancer.
OBJECTIVES:
- Assess the disease free survival of patients with localized adenocarcinoma of the
prostate cancer.
- 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
class III/IV).
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
flutamide therapy.
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
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