Spots Global Cancer Trial Database for Radiation Therapy in Treating Patients With Prostate Cancer

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Trial Identification

Brief Title: Radiation Therapy in Treating Patients With Prostate Cancer

Official Title: Phase I Study of 3-Dimensional Conformal Radiotherapy in Patients With Locally Advanced (Stage T2c and T3) Adenocarcinoma of the Prostate

Study ID: NCT00002480

Conditions

Prostate Cancer

Interventions

radiation therapy

Study Description

Brief Summary: RATIONALE: Radiation therapy uses high-energy x-rays to damage tumor cells. Radiation therapy may be an effective treatment for prostate cancer. PURPOSE: Phase I trial to study the effectiveness of radiation therapy in treating patients who have stage II or stage III prostate cancer.

Detailed Description: 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 thereafter. PROJECTED ACCRUAL: A minimum of 40 patients will be accrued for this study.