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

Prostate Cancer Clinical Trial

Official title: Phase II Trial Of Combined High Dose Rate Brachytherapy And External Beam Radiotherapy For Adenocarcinoma Of The Prostate

Status Completed

Clinical Trial Summary

RATIONALE: Radiation therapy uses high-energy x-rays and other sources to damage tumor cells. Internal radiation therapy uses radioactive material placed directly into or near a tumor to kill tumor cells. Giving radiation therapy in different ways may kill more tumor cells.

PURPOSE: This phase II trial is studying how well giving internal radiation therapy together with external-beam radiation therapy works in treating patients with stage II or stage III prostate cancer.

Clinical Trial Description

OBJECTIVES:

Primary

• Determine the rate of late grade 3 or greater genitourinary and gastrointestinal toxicity after treatment with external beam radiotherapy and high-dose rate brachytherapy in patients with stage II or III adenocarcinoma of the prostate.

Secondary

• Determine acute grade 3 or greater genitourinary and gastrointestinal toxicity in patients treated with this regimen.

• Determine freedom from biochemical failure in patients treated with this regimen.

• Determine overall survival of patients treated with this regimen.

• Determine disease-specific survival of patients treated with this regimen.

• Determine clinical relapse (local and/or distant) in patients treated with this regimen.

• Develop a quality assurance process for high-dose rate prostate brachytherapy.

OUTLINE: This is a multicenter study. Patients are stratified according to prostate-specific antigen (≤ 10 ng/mL vs 11-20 ng/mL), T stage (T1c-T2c vs T3a-T3b), combined Gleason score (2-6 vs 7 vs 8-10), prior hormonal therapy (no vs yes), and timing of high-dose rate brachytherapy (before external beam radiotherapy vs after external beam radiotherapy).

Patients are followed at 3, 7, 9, and 12 months, every 6 months for 5 years, and then annually thereafter. ;

Related Conditions & MeSH terms

• Prostate Cancer
• Prostatic Neoplasms

• NCT number: NCT00091390
• Study type: Interventional
• Source: Radiation Therapy Oncology Group
• Status: Completed
• Phase: Phase 2
• Start date: July 2004
• Completion date: December 2016