Improving Assessment (and Ultimately Outcomes) of Permanent Prostate Implant Therapy
| Tracking Information | |||||
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| First Received Date ICMJE | August 5, 2005 | ||||
| Last Updated Date | March 19, 2012 | ||||
| Start Date ICMJE | April 2005 | ||||
| Estimated Primary Completion Date | June 2012 (final data collection date for primary outcome measure) | ||||
| Current Primary Outcome Measures ICMJE |
implant dose coverage at 4 weeks, comparing CT and MRI versus CT alone | ||||
| Original Primary Outcome Measures ICMJE |
-implant dose coverage at 4 weeks, comparing CT and MRI versus CT alone | ||||
| Change History | Complete list of historical versions of study NCT00127816 on ClinicalTrials.gov Archive Site | ||||
| Current Secondary Outcome Measures ICMJE |
implant edema at time of implant and at 2 and 4 weeks | ||||
| Original Secondary Outcome Measures ICMJE |
-implant edema at time of implant and at 2 and 4 weeks | ||||
| Current Other Outcome Measures ICMJE | Not Provided | ||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||
| Descriptive Information | |||||
| Brief Title ICMJE | Improving Assessment (and Ultimately Outcomes) of Permanent Prostate Implant Therapy | ||||
| Official Title ICMJE | Improving Assessment (and Ultimately Outcomes) of Permanent Prostate Implant Therapy | ||||
| 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%. |
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| 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:
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. |
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| Study Type ICMJE | Interventional | ||||
| Study Phase | Not Provided | ||||
| Study Design ICMJE | Endpoint Classification: Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
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| Condition ICMJE | Prostate Cancer | ||||
| Intervention ICMJE | Procedure: Permanent prostate implant | ||||
| Study Arm (s) | Not Provided | ||||
| Publications * |
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||
| Recruitment Status ICMJE | Active, not recruiting | ||||
| Estimated Enrollment ICMJE | 40 | ||||
| Estimated Completion Date | December 2012 | ||||
| Estimated Primary Completion Date | June 2012 (final data collection date for primary outcome measure) | ||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Male | ||||
| Ages | Not Provided | ||||
| Accepts Healthy Volunteers | No | ||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
| Location Countries ICMJE | Canada | ||||
| Administrative Information | |||||
| NCT Number ICMJE | NCT00127816 | ||||
| Other Study ID Numbers ICMJE | SP-14-0044 / 21694, RIP Project 21694 | ||||
| Has Data Monitoring Committee | Yes | ||||
| Responsible Party | Alberta Health Services | ||||
| Study Sponsor ICMJE | Alberta Health Services | ||||
| Collaborators ICMJE | Not Provided | ||||
| Investigators ICMJE |
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| Information Provided By | Alberta Health Services | ||||
| Verification Date | March 2012 | ||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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