Radiation Therapy in Treating Patients With Stage II or Stage III Prostate Cancer
Radiation Therapy in Treating Patients With Stage II or Stage III Prostate Cancer
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.
DISEASE CHARACTERISTICS: Previously untreated adenocarcinoma of the prostate T1b-c or T2a-b
 with a Gleason score more than 5 and PSA greater than 4 ng/mL OR Any T3 PSA under 70 ng/mL
 within 3 weeks prior to entry and at least 10 days after prostate biopsy No biopsy proven
 regional nodal involvement No distant metastases

 PATIENT CHARACTERISTICS: Age: 18 and over Performance status: Karnofsky 80-100%
 Hematopoietic: White blood cell (WBC) count of at least 4,000/mm3 Platelet count at least
 100,000/mm3 Hemoglobin at least 11 g/dL Hepatic: Not specified Renal: Not specified Other:
 No major medical or psychiatric illness that would preclude study No other malignancy
 within the past 5 years

 PRIOR CONCURRENT THERAPY: Biologic therapy: Not specified Chemotherapy: No prior or
 concurrent chemotherapy Endocrine therapy: Prior hormonal therapy allowed Radiotherapy: No
 prior pelvic irradiation Surgery: No prior prostatectomy or cryosurgery for prostate cancer