Intensity Modulated Versus Interstitial - Radiation Therapy
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|ClinicalTrials.gov Identifier: NCT00407875|
Recruitment Status : Suspended (Accrual has been very slow. We are currently determining whether or not to keep the trial going as is or to close the trial and write a new protocol.)
First Posted : December 5, 2006
Last Update Posted : October 15, 2009
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).
|Condition or disease||Intervention/treatment||Phase|
|Prostate Cancer||Procedure: Intensity Modulated External Beam Radiation Therapy||Phase 2|
Show Detailed Description
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||50 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|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|
|Study Start Date :||March 2007|
|Study Completion Date :||November 2016|
- 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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00407875
|Canada, British Columbia|
|BC Cancer Agency|
|Vancouver, British Columbia, Canada, V5Z 4E6|
|Principal Investigator:||William J Morris, MD||British Columbia Cancer Agency|