NCT00006365

External-Beam Radiation Therapy Plus Implanted Radiation Therapy in Treating Patients With Prostate Cancer

A Phase II Study of External Beam Radiation Therapy Combined With Permanent Source Brachytherapy for Intermediate Risk Clinically Localized Adenocarcinoma of the Prostate

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 138 (actual)
• Sponsor: Radiation Therapy Oncology Group · Network
• Sex: Male
• Age: 18 Years – 120 Years
• Healthy volunteers: Not accepted

Summary

RATIONALE: Radiation therapy uses high-energy x-rays and other sources to damage tumor cells. Giving radiation therapy in different ways may kill more tumor cells. PURPOSE: Phase II trial to study the effectiveness of external-beam radiation therapy followed by implanted radiation therapy in treating patients who have prostate cancer.

Detailed description

OBJECTIVES: I. Determine the acute and late grade 3-5 genitourinary (GU) and gastrointestinal (GI) toxic effects of external beam radiotherapy followed by permanent source brachytherapy using interstitial iodine I 125 seeds in patients with intermediate risk, clinically localized adenocarcinoma of the prostate. II. Determine the freedom from prostate specific antigen (PSA) failure, overall survival, disease specific survival, and local and/or distant clinical relapse rates in patients treated with this regimen. OUTLINE: This is a multicenter study. Patients undergo external beam radiotherapy (EBRT) to the pelvis 5 days a week for 5 weeks. Permanent source brachytherapy comprised of ultrasound-guided implantation of iodine I 125 seeds into the prostate is performed 2-6 weeks after completion of EBRT. Patients are followed at 1, 3, 6, 9, and 12 months, then every 6 months for 2 years, and then annually thereafter. PROJECTED ACCRUAL: A total of 110 patients will be accrued for this study within 1 year.

Conditions

• Prostate Cancer

Interventions

Type	Name	Description
RADIATION	brachytherapy
RADIATION	iodine I 125
RADIATION	radiation therapy

Timeline

• Start date: 2000-11-01
• Primary completion: 2006-12-01
• Completion: 2013-11-01
• First posted: 2004-02-26
• Last updated: 2020-10-22

Locations

254 sites across 2 countries: United States, Canada