NCT00023686

Surgery Versus Internal Radiation in Treating Patients With Stage II Prostate Cancer

A Randomized Trial of Radical Prostatectomy Versus Brachytherapy for Patients With T1c or T2a N0 M0 Prostate Cancer

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 190 (actual)
• Sponsor: Alliance for Clinical Trials in Oncology · Academic / Other
• Sex: Male
• Age: 75 Years
• Healthy volunteers: Not accepted

Summary

RATIONALE: Internal radiation uses radioactive material placed directly into or near a tumor to kill tumor cells. It is not yet known whether surgery is more effective than internal radiation in treating prostate cancer. PURPOSE: Randomized phase III trial to compare the effectiveness of surgery with that of internal radiation in treating patients who have stage II prostate cancer.

Detailed description

OBJECTIVES: * Compare overall survival in patients with stage II prostate cancer treated with radical prostatectomy vs brachytherapy. * Compare metastasis-free survival and probability of survival without symptoms of patients treated with these regimens. * Compare the side effects of these treatment regimens in these patients. OUTLINE: This is a randomized study. Patients are randomized to one of two treatment arms. * Arm I: Patients undergo radical prostatectomy. * Arm II: Patients undergo brachytherapy with implanted iodine I 125 or palladium Pd 103 seeds Patients are followed every 6 months for 5 years and then annually thereafter. PROJECTED ACCRUAL: A total of 1,980 patients (990 per treatment arm) will be accrued for this study within 5.5 years.

Conditions

• Prostate Cancer

Interventions

Type	Name	Description
PROCEDURE	surgery
RADIATION	radiation

Timeline

• Start date: 2001-10-01
• Primary completion: 2004-04-01
• Completion: 2004-04-01
• First posted: 2003-01-27
• Last updated: 2016-07-06

Locations

36 sites across 2 countries: United States, Canada