Ignite Creation Date:
2024-05-05 @ 11:45 AM
Last Modification Date:
2024-10-26 @ 9:13 AM
Study NCT ID:
NCT00127816
Status:
COMPLETED
Last Update Posted:
2016-03-16
First Post:
2005-08-05
Brief Title:
Improving Assessment and Ultimately Outcomes of Permanent Prostate Implant Therapy
Sponsor:
AHS Cancer Control Alberta
Organization:
AHS Cancer Control Alberta
Study Overview
Official Title:
Improving Assessment and Ultimately Outcomes of Permanent Prostate Implant Therapy
Status:
COMPLETED
Status Verified Date:
2016-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Permanent prostate implants are a type of radiation therapy in which a high dose of radiation is delivered to cancerous tissue by many small radioactive seeds Studies of early-stage prostate cancer patients treated in this way and followed for 10 - 12 years indicate a cure rate of about 80 This result is similar to surgery and other forms of radiotherapy but comes with fewer side effects and greater convenience for the patient Further studies show that the radiation dose delivered is the most important factor in achieving a cure At present this dose is estimated by a computer using a computed tomography CT scan of the patient and a simple calculation method The dose estimate is not as accurate as it could be however because the precise extent of the prostate is hard to determine from the CT scan and the calculation method does not make use of information about patient body tissues The researchers propose to eliminate these inaccuracies by using magnetic resonance imaging MRI to identify the prostate gland and by developing an improved dose calculation algorithm that includes information about patient tissues This new approach will allow physicians to assess implant quality with greater certainty improve their implant technique and ultimately increase the cure rate to as much as 95
Detailed Description:
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 250000 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
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 250000 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| RIP Project 21694 | None | None | None |