Intensity Modulated Versus Interstitial - Radiation Therapy
The purpose of this trial is to compare two different treatment options for patients with low risk and low-tier intermediate risk prostate cancer. The two treatment arms being compared in this study are: (control arm) permanent interstitial prostate brachytherapy (PIPB) VERSUS (experimental arm) intensity modulated external beam radiation therapy (IMRT).
The acute and late toxicities experienced by patients in the experimental arm (IMRT) are not significantly worse then the toxicities experienced by patients in the control arm (PIPB).
Procedure: Intensity Modulated External Beam Radiation Therapy
|Study Design:||Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||A Randomized Phase II Study Comparing Intensity Modulated External Beam Radiation Therapy (IMRT) Versus Permanent Interstitial Prostate Brachytherapy (PIPB) for Low Risk and Low-tier Intermediate Risk Prostate Cancer|
- The primary end point of this study is the acute and late toxicities of the therapeutic interventions.
- The willingness of eligible patients to be randomized to the treatment interventions.
- Obstacles to accrual that need to be addressed.
- Testing our ability to meet accrual targets.
- Checking quality assurance benchmarks for IMRT and PIPB procedures.
- Discovering and relieving bottlenecks in IMRT planning and procedures.
- Quality of life.
- Pathological local control.
- Biochemical relapse-free survival.
- Metastasis-free survival.
- Overall survival.
|Study Start Date:||March 2007|
|Estimated Study Completion Date:||November 2016|
Please refer to this study by its ClinicalTrials.gov identifier: NCT00407875
|Canada, British Columbia|
|BC Cancer Agency|
|Vancouver, British Columbia, Canada, V5Z 4E6|
|Principal Investigator:||William J Morris, MD||British Columbia Cancer Agency|