Improving Assessment (and Ultimately Outcomes) of Permanent Prostate Implant Therapy

Sponsor
AHS Cancer Control Alberta (Other)
Overall Status
Completed
CT.gov ID
NCT00127816
Collaborator
Cross Cancer Institute (Other)
40
1
96
0.4

Study Details

Study Description

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%.

Condition or Disease Intervention/Treatment Phase
  • Procedure: Permanent prostate implant
N/A

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 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 Design

Study Type:
Interventional
Actual Enrollment :
40 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Improving Assessment (and Ultimately Outcomes) of Permanent Prostate Implant Therapy
Study Start Date :
Apr 1, 2005
Actual Primary Completion Date :
Apr 1, 2013
Actual Study Completion Date :
Apr 1, 2013

Outcome Measures

Primary Outcome Measures

  1. implant dose coverage at 4 weeks, comparing CT and MRI versus CT alone []

Secondary Outcome Measures

  1. implant edema at time of implant and at 2 and 4 weeks []

Eligibility Criteria

Criteria

Ages Eligible for Study:
N/A and Older
Sexes Eligible for Study:
Male
Accepts Healthy Volunteers:
No
Inclusion Criteria:
  • Candidate for permanent prostate implant
Exclusion Criteria:
  • Not ambulatory

Contacts and Locations

Locations

Site City State Country Postal Code
1 Cross Cancer Institute Edmonton Alberta Canada T6G 1Z2

Sponsors and Collaborators

  • AHS Cancer Control Alberta
  • Cross Cancer Institute

Investigators

  • Principal Investigator: Ron Sloboda, PhD, AHS Cancer Control Alberta

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:
AHS Cancer Control Alberta
ClinicalTrials.gov Identifier:
NCT00127816
Other Study ID Numbers:
  • SP-14-0044 / 21694
  • RIP Project 21694
First Posted:
Aug 9, 2005
Last Update Posted:
Mar 16, 2016
Last Verified:
Mar 1, 2016
Keywords provided by AHS Cancer Control Alberta
Additional relevant MeSH terms:

Study Results

No Results Posted as of Mar 16, 2016