Study of High-dose Rate (HDR) Monotherapy for Low and Intermediate Risk Prostate Cancer
NCT ID: NCT02077335
Last Updated: 2024-02-21
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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ACTIVE_NOT_RECRUITING
PHASE2
50 participants
INTERVENTIONAL
2014-04-30
2026-03-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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HDR brachytherapy monotherapy
Radiation therapy: Treatment with 2 separate HDR brachytherapy implants, each with one fraction of 13.5 Gray (Gy) with an interval of 7-14 days between treatments.
HDR brachytherapy monotherapy
Radiation therapy in the study consists of treatment with 2 separate interstitial HDR brachytherapy procedures with temporary interstitial catheters, each with one fraction of 13.5 Gray (Gy). Both procedures will be done in an identical manner. The 2 procedures will be separated by an interval of 7-14 days Treatments will be done with interstitial catheters inserted transperineally with transrectal ultrasound guidance under sterile conditions. Optimization of treatment plan will be done with Brachyvision software (Varian, Palo Alto CA) based on CT-scan imaging done post-implant. Optimization parameters will be the following:
Prostate :
* V100 \> 95%
* V150 30-35%
* V200 \< 15%
* D90 \> 90% (12,15Gy)
Bladder
• V75 \< 1cc
Rectum
• V75 \< 1cc
Urethra
V125 = 0cc D10 \< 120%
Treatments will be carried out with an Iridium-192 afterloader. Source and all catheters will be removed from the patient at the end of the procedure.
Interventions
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HDR brachytherapy monotherapy
Radiation therapy in the study consists of treatment with 2 separate interstitial HDR brachytherapy procedures with temporary interstitial catheters, each with one fraction of 13.5 Gray (Gy). Both procedures will be done in an identical manner. The 2 procedures will be separated by an interval of 7-14 days Treatments will be done with interstitial catheters inserted transperineally with transrectal ultrasound guidance under sterile conditions. Optimization of treatment plan will be done with Brachyvision software (Varian, Palo Alto CA) based on CT-scan imaging done post-implant. Optimization parameters will be the following:
Prostate :
* V100 \> 95%
* V150 30-35%
* V200 \< 15%
* D90 \> 90% (12,15Gy)
Bladder
• V75 \< 1cc
Rectum
• V75 \< 1cc
Urethra
V125 = 0cc D10 \< 120%
Treatments will be carried out with an Iridium-192 afterloader. Source and all catheters will be removed from the patient at the end of the procedure.
Eligibility Criteria
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Inclusion Criteria
* Clinical stage T1c, T2a or T2b
* PSA less than 20 ng/ml
* Gleason Score 6 or 7
Exclusion Criteria
* Clinical stage T2c, T3 ou T4
* Clinical Stage N1
* Clinical Stage M1
* Prostate Specific Antigen (PSA) more than 20 ng/ml
* Gleason score 8 or higher
* IPSS score 19 or higher with alpha-blockers
* Past radiation therapy to the pelvis
* History of Collagen Vascular Disease
* History of Inflammatory Bowel Disease
* Bilateral Hip Prosthesis
18 Years
MALE
No
Sponsors
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CSSS de Gatineau
OTHER
Responsible Party
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Marc Gaudet
Radiation Oncologist
Locations
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CSSS de Gatineau
Gatineau, Quebec, Canada
Countries
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Other Identifiers
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CSSSG-001
Identifier Type: -
Identifier Source: org_study_id
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