NCT00003607

Radiation Therapy in Treating Patients With Stage I, Stage II, or Stage III Prostate Cancer

Phase III Randomized Study of Radiotherapy to the Prostate With or Without Radiotherapy to the Pelvis in Patients With Stage I, II, or III Adenocarcinoma of the Prostate

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 450 (estimated)
• Sponsor: UNICANCER · Academic / Other
• Sex: Male
• Age: 75 Years
• Healthy volunteers: Not accepted

Summary

RATIONALE: Radiation therapy uses high-energy x-rays to damage tumor cells. It is not yet known whether radiation therapy to the prostate and pelvis is more effective than radiation therapy to the prostate alone in treating prostate cancer. PURPOSE: Randomized phase III trial to compare the effectiveness of radiation therapy to the prostate with or without radiation to the pelvis in treating patients with stage I, stage II, or stage III prostate cancer.

Detailed description

OBJECTIVES: * Compare the survival without recurrence and overall survival of patients with stage I, II, or III adenocarcinoma of the prostate after receiving radiotherapy to the prostate with or without radiotherapy to the pelvis. * Compare the toxic effects of these two regimens in these patients. * Compare the quality of life of patients treated with these regimens. * Determine the prognostic factors of progression in these patients. * Analyze the site of relapse (prostate, pelvic lymph nodes, metastases) in case of progression in these patients. OUTLINE: This is a randomized, multicenter study. Patients are stratified by participating center and prognostic group (poor vs good prognosis). Patients are randomized to one of two treatment arms. * Arm I: Patients receive pelvic irradiation plus local prostate irradiation. * Arm II: Patients receive local prostate irradiation only. Radiotherapy in both arms is administered 5 days a week for 7 weeks. Quality of life is assessed before therapy, 12 months after therapy, and then annually thereafter. Patients are followed at 2 and 6 months and then every 6 months thereafter. PROJECTED ACCRUAL: A total of 450 patients will be accrued for this study within 4 years.

Conditions

• Prostate Cancer

Interventions

Type	Name	Description
RADIATION	radiation therapy

Timeline

• Start date: 1997-12-01
• Primary completion: 2002-12-01
• Completion: 2015-01-01
• First posted: 2003-01-27
• Last updated: 2016-06-23

Locations

23 sites across 1 country: France