Improving Assessment (and Ultimately Outcomes) of Permanent Prostate Implant Therapy
|Study Design:||Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
|Official Title:||Improving Assessment (and Ultimately Outcomes) of Permanent Prostate Implant Therapy|
- 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
|Study Start Date:||April 2005|
|Study Completion Date:||April 2013|
|Primary Completion Date:||April 2013 (Final data collection date for primary outcome measure)|
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00127816
|Cross Cancer Institute|
|Edmonton, Alberta, Canada, T6G 1Z2|
|Principal Investigator:||Ron Sloboda, PhD||AHS Cancer Control Alberta|