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Sponsored by: |
Alberta Cancer Board |
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Information provided by: | Alberta Cancer Board |
ClinicalTrials.gov Identifier: | NCT00127816 |
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 |
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Prostate Cancer |
Procedure: Permanent prostate implant |
Study Type: | Interventional |
Study Design: | Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Efficacy Study |
Official Title: | Improving Assessment (and Ultimately Outcomes) of Permanent Prostate Implant Therapy |
Estimated Enrollment: | 40 |
Study Start Date: | April 2005 |
Estimated Study Completion Date: | December 2007 |
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:
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.
Genders Eligible for Study: | Male |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contact: Ron Sloboda, PhD | 780-432-8719 | ron.sloboda@cancerboard.ab.ca |
Canada, Alberta | |
Cross Cancer Institute | Recruiting |
Edmonton, Alberta, Canada, T6G 1Z2 | |
Contact: Clinical Research Unit 780-989-8152 clinical_trials_cci@cancerboard.ab.ca | |
Principal Investigator: Ron Sloboda, PhD |
Principal Investigator: | Ron Sloboda, PhD | Alberta Cancer Board |
Study ID Numbers: | SP-14-0044, RIP Project 21694 |
Study First Received: | August 5, 2005 |
Last Updated: | September 22, 2008 |
ClinicalTrials.gov Identifier: | NCT00127816 History of Changes |
Health Authority: | Canada: Health Canada |
brachytherapy implant radiotherapy |
Prostatic Diseases Genital Neoplasms, Male Urogenital Neoplasms Genital Diseases, Male Prostatic Neoplasms |
Neoplasms Neoplasms by Site Prostatic Diseases Genital Neoplasms, Male |
Urogenital Neoplasms Genital Diseases, Male Prostatic Neoplasms |