Improving Assessment (and Ultimately Outcomes) of Permanent Prostate Implant Therapy
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|ClinicalTrials.gov Identifier: NCT00127816|
Recruitment Status : Completed
First Posted : August 9, 2005
Last Update Posted : March 16, 2016
|Condition or disease||Intervention/treatment||Phase|
|Prostate Cancer||Procedure: Permanent prostate implant||Not Applicable|
This study addresses three major sources of post-implant dosimetry inaccuracy for permanent prostate implants: post-operative edema, prostate contour delineation, and dose calculation method. It is hypothesized that a pragmatic edema model can minimize the first uncertainty, co-registered CT + MR images the second, and an improved dose calculation algorithm the third.
Detailed objectives are to:
- measure and model the effects of edema on dosimetry;
- evaluate CT + MR image registration methods;
- compare dosimetry for CT alone vs. CT + MRI using the contemporary TG-43 dose calculation method;
- set up a Monte Carlo code that makes full use of the information in CT + MR images to perform implant dose calculations;
- compare prostate dosimetry for the Monte Carlo vs. the simpler TG-43 method;
- develop an analytical post-implant dose calculation algorithm for routine clinical use (Monte Carlo is too slow on a single-CPU brachytherapy planning computer); and finally
- assess the performance of the new algorithm.
Of the estimated 250,000 new cases of prostate cancer in North America in 2004, most are early stage disease as a consequence of PSA testing. Permanent prostate implant therapy is a major option for this group, as long-term clinical studies indicate a cure rate equal to surgery and external beam radiotherapy, but with fewer complications. By dealing with dosimetric inaccuracies, a proven treatment can reach its full potential.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||40 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Improving Assessment (and Ultimately Outcomes) of Permanent Prostate Implant Therapy|
|Study Start Date :||April 2005|
|Actual Primary Completion Date :||April 2013|
|Actual Study Completion Date :||April 2013|
- implant dose coverage at 4 weeks, comparing CT and MRI versus CT alone
- implant edema at time of implant and at 2 and 4 weeks
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): NCT00127816
|Cross Cancer Institute|
|Edmonton, Alberta, Canada, T6G 1Z2|
|Principal Investigator:||Ron Sloboda, PhD||AHS Cancer Control Alberta|