Radiation Therapy Compared With No Further Treatment Following Surgery in Treating Patients With Prostate Cancer

Prostate Cancer Clinical Trial

Official title: PHASE III STUDY OF POST-OPERATIVE EXTERNAL RADIOTHERAPY IN PATHOLOGICAL STAGE T3 N0 PROSTATIC CARCINOMA

Status Completed

Clinical Trial Summary

RATIONALE: Radiation therapy uses high-energy x-rays to damage tumor cells and may be an effective treatment for prostate cancer.

PURPOSE: Randomized phase III trial to compare radiation therapy with no further treatment in treating patients with stage III prostate cancer following radical prostatectomy.

Clinical Trial Description

OBJECTIVES:

• Compare local recurrence rates, acute and late morbidity, overall survival, disease-free survival, and cancer-related survival of patients with pT3 pN0 adenocarcinoma of the prostate randomized following radical prostatectomy to postoperative conventional pelvic irradiation (60 Gy) vs no further treatment until relapse.

• Better define the selective pathologic indications for radiotherapy in patients with pT3 pN0 disease.

OUTLINE: This is a randomized study.

• Arm I: Patients undergo radiotherapy daily, 5 days a week, for 5 weeks, followed by boost radiotherapy for 1-1.4 weeks.

• Arm II: Patients are observed. Local relapse is treated with conventional pelvic radiotherapy.

Patients are followed every 3 months during the first postoperative year, every 6 months until the fifth year, and annually thereafter.

PROJECTED ACCRUAL: A total of 1000 patients will be accrued for this study within 7.5 years. ;

Study Design

Primary Purpose: Treatment

Related Conditions & MeSH terms

• Prostate Cancer
• Prostatic Neoplasms

• NCT number: NCT00002511
• Study type: Interventional
• Source: European Organisation for Research and Treatment of Cancer - EORTC
• Status: Completed
• Phase: Phase 3
• Start date: December 1992