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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
AHS Cancer Control Alberta
ClinicalTrials.gov Identifier:
NCT00127816
First received: August 5, 2005
Last updated: February 3, 2014
Last verified: February 2014
  Purpose

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 Intervention
Prostate Cancer
Procedure: Permanent prostate implant

Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Improving Assessment (and Ultimately Outcomes) of Permanent Prostate Implant Therapy

Resource links provided by NLM:


Further study details as provided by AHS Cancer Control Alberta:

Primary Outcome Measures:
  • implant dose coverage at 4 weeks, comparing CT and MRI versus CT alone

Secondary Outcome Measures:
  • implant edema at time of implant and at 2 and 4 weeks

Estimated Enrollment: 40
Study Start Date: April 2005
Estimated Study Completion Date: March 2014
Estimated Primary Completion Date: March 2014 (Final data collection date for primary outcome measure)
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.

  Eligibility

Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Candidate for permanent prostate implant

Exclusion Criteria:

  • Not ambulatory
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00127816

Locations
Canada, Alberta
Cross Cancer Institute
Edmonton, Alberta, Canada, T6G 1Z2
Sponsors and Collaborators
AHS Cancer Control Alberta
Investigators
Principal Investigator: Ron Sloboda, PhD AHS Cancer Control Alberta
  More Information

Publications:
Responsible Party: AHS Cancer Control Alberta
ClinicalTrials.gov Identifier: NCT00127816     History of Changes
Other Study ID Numbers: SP-14-0044 / 21694, RIP Project 21694
Study First Received: August 5, 2005
Last Updated: February 3, 2014
Health Authority: Canada: Health Canada

Keywords provided by AHS Cancer Control Alberta:
brachytherapy
implant radiotherapy

Additional relevant MeSH terms:
Prostatic Neoplasms
Genital Diseases, Male
Genital Neoplasms, Male
Neoplasms
Neoplasms by Site
Prostatic Diseases
Urogenital Neoplasms

ClinicalTrials.gov processed this record on October 21, 2014