NCT00002511

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

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

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 1,005 (actual)
• Sponsor: European Organisation for Research and Treatment of Cancer - EORTC · Network
• Sex: All
• Age: 75 Years
• Healthy volunteers: Not accepted

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.

Detailed 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.

Conditions

• Prostate Cancer

Interventions

Type	Name	Description
RADIATION	low-LET photon therapy

Timeline

• Start date: 1992-12-01
• Primary completion: 2001-12-01
• First posted: 2003-01-27
• Last updated: 2012-10-16

Locations

1 site across 1 country: Belgium