Prostate Cancer Clinical Trial
Official title:
A PHASE I/II DOSE ESCALATION STUDY USING THREE DIMENSIONAL CONFORMAL RADIATION THERAPY FOR ADENOCARCINOMA OF THE PROSTATE
RATIONALE: Radiation therapy uses high-energy x-rays to damage tumor cells and may be an
effective treatment for prostate cancer.
PURPOSE: Phase I/II trial to study the effectiveness of radiation therapy in treating
patients who have previously untreated stage II or stage III prostate cancer.
OBJECTIVES: I. Determine the maximum tolerated dose of 3-dimensional conformal radiotherapy
to the prostate gland and immediately surrounding tissues in patients with stage II or III
adenocarcinoma of the prostate. II. Determine the normal tissue toxicity rate of this regimen
in the rectums and bladders of these patients. III. Determine local control by clinical and
pathologic examination and by PSA determinations in patients treated with this regimen. IV.
Determine the distant failure and overall survival of patients treated with this regimen.
OUTLINE: This is a dose escalation study. Patients are stratified according to 1 of the
following 3 prognostic groups: Group 1: T1b-c or T2a-b with combined PSA/Gleason (CPG) score
15 and under Group 2: T1b-c or T2a-b with CPG score more than 15, or any T2c with PSA less
than 70 ng/mL Group 3: T3 with prostate specific antigen (PSA) less than 70 ng/mL Patients
receive 3-dimensional (3-D) conformal radiotherapy 5 days a week for 7.6, 8.2, or 8.8 weeks.
Cohorts of 120-270 patients receive escalating doses of 3-D conformal radiotherapy until the
maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at
which 20% of patients experience dose-limiting toxicity. Patients are followed every 3 months
for 1 year, every 4 months for 1 year, every 6 months for 3 years, and then annually
thereafter.
PROJECTED ACCRUAL: A total of 549-801 patients (120-204 patients for the first dose level,
237-321 patients for the second dose level, and 192-276 patients for the third dose level)
will be accrued for this study within 4.75 to 5.25 years.
;
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