Back to resultsCT-validation of Ultrasound Based Planning for High Dose Rate (HDR) Prostate Brachytherapy Using Vitesse (Vitesse)
Primary Purpose
Prostate Cancer, Interstitial Radiation, High Dose Rate Brachytherapy
Status
Completed
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
HDR prostate brachytherapy
Sponsored by
About this trial
This is an interventional treatment trial for Prostate Cancer focused on measuring prostate cancer, interstitial radiation,, brachytherapy
Eligibility Criteria
Inclusion Criteria:
- Patients must have histologically proven adenocarcinoma of the prostate.
- Patients must have intermediate risk prostate cancer. (Clinical stage ≤ T2c, Gleason score = 7 and initial prostate specific antigen (iPSA) ≤ 20, or Gleason score ≤ 6 and iPSA > 10 and ≤ 20.
- Patients must be fit for general or spinal anaesthetic.
- Patients must have an estimated life expectancy of at least 10 years.
- Patients must have an Eastern Cooperative Oncology Group (ECOG) performance status of 0 - 2.
- Patients must have no contraindications to interstitial prostate brachytherapy.
- Patients on coumadin therapy must be able to stop therapy safely for at least 7 days.
Exclusion Criteria:
- Men not able to fully understand the trial and the informed consent document
- Men suffering from claustrophobia and unable to have a Computed Tomography scan
- Men not wishing to have a cone-beam Computed Tomography scan following the insertion of the High Dose Rate brachytherapy needles to verify the accuracy of the treatment plan
- Men who cannot safely discontinue blood thinners for a few days.
Sites / Locations
- BCCA Center for the Southern Interior
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
HDR prostate brachytherapy
Arm Description
An array of 17 gauge steel needles, 20 cm in length, is inserted under Ultrasound (US) guidance into the prostate and advanced to the base of the prostate. A template is used to maintain spacing and parallelism and the needles are individually locked into the template once positioned. A continuously acquired set of US images is obtained for treatment planning purposes. Each needle is connected to a Varisource afterloader and treatment is delivered using a 10 Curie Iridium-192 source. The needles are then removed.
Outcomes
Primary Outcome Measures
Accuracy of Needle Tip Identification on TransRectal UltraSound Compared to Computed Tomography
Precise location of the tip of each needle in 3-dimensional space relative to the prostate determines the pattern of dose delivery. Inaccuracies in needle tip location may lead to differences detected between UltraSound(US)-based and Computed Tomography (CT)-based plans.The distance of the needle tip (as identified on either CT images or US images) protruding beyond the template was measured in mm. The template acted as a fixed reference point as it was locked into the stabilizer/stepper apparatus. The 2 protrusion readings for each needle tip were compared, the difference recorded in mm, and categorized as < 1 mm, 1-2 mm, 2-3 mm and > 3 mm.
Secondary Outcome Measures
Full Information
NCT ID
NCT01248741
First Posted
November 3, 2010
Last Updated
November 17, 2020
Sponsor
British Columbia Cancer Agency
1. Study Identification
Unique Protocol Identification Number
NCT01248741
Brief Title
CT-validation of Ultrasound Based Planning for High Dose Rate (HDR) Prostate Brachytherapy Using Vitesse
Acronym
Vitesse
Official Title
High Dose Rate (HDR)Prostate Brachytherapy With Vitesse tm
Study Type
Interventional
2. Study Status
Record Verification Date
November 2020
Overall Recruitment Status
Completed
Study Start Date
December 2010 (undefined)
Primary Completion Date
April 2012 (Actual)
Study Completion Date
May 2012 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
British Columbia Cancer Agency
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
High Dose Rate (HDR) temporary prostate brachytherapy offers a precise form of dose escalation for prostate cancer. Needles are placed, the position is confirmed and treatment is delivered. Previously High Dose Rate prostate brachytherapy was performed under TransRectal UltraSound (TRUS) guidance but planned with Computed Tomography (CT) imaging which introduced a source of error through needle displacement while transporting and repositioning patient. Recently Varian has introduced a one-step procedure where both implant and planning are based on UltraSound imaging and performed without patient repositioning. This planning system is approved by Health Canada and is commercially available.
This study will use High Dose Rate brachytherapy to treat 20 men. Treatment will be planned with TransRectal UltraSound and validated using Computed Tomography imaging.
Detailed Description
Twenty men with intermediate risk prostate cancer, suitable for the combination of external beam radiotherapy and High Dose Rate brachytherapy will be entered in this study. High Dose Rate brachytherapy will be performed using TransRectal UltraSound guidance and then planned using both cone-beam Computed Tomography and TransRectal UltraSound. Planning by Computed Tomography is to check the reliability and reproducibility of UltraSound imaging to correctly identify the needle positions. Correct needle localization is essential because this is the basis for determining source dwell positions, dose calculation and dose optimization.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Prostate Cancer, Interstitial Radiation, High Dose Rate Brachytherapy, Ultrasound-based Planning Compared to CT-based Planning
Keywords
prostate cancer, interstitial radiation,, brachytherapy
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
20 (Actual)
8. Arms, Groups, and Interventions
Arm Title
HDR prostate brachytherapy
Arm Type
Experimental
Arm Description
An array of 17 gauge steel needles, 20 cm in length, is inserted under Ultrasound (US) guidance into the prostate and advanced to the base of the prostate. A template is used to maintain spacing and parallelism and the needles are individually locked into the template once positioned. A continuously acquired set of US images is obtained for treatment planning purposes. Each needle is connected to a Varisource afterloader and treatment is delivered using a 10 Curie Iridium-192 source. The needles are then removed.
Intervention Type
Radiation
Intervention Name(s)
HDR prostate brachytherapy
Intervention Description
HDR prostate brachytherapy to be delivered in 2 fractions of 10 Gray as a "boost" combined with external beam radiotherapy
Primary Outcome Measure Information:
Title
Accuracy of Needle Tip Identification on TransRectal UltraSound Compared to Computed Tomography
Description
Precise location of the tip of each needle in 3-dimensional space relative to the prostate determines the pattern of dose delivery. Inaccuracies in needle tip location may lead to differences detected between UltraSound(US)-based and Computed Tomography (CT)-based plans.The distance of the needle tip (as identified on either CT images or US images) protruding beyond the template was measured in mm. The template acted as a fixed reference point as it was locked into the stabilizer/stepper apparatus. The 2 protrusion readings for each needle tip were compared, the difference recorded in mm, and categorized as < 1 mm, 1-2 mm, 2-3 mm and > 3 mm.
Time Frame
Treatment was planned and delivered based on ultrasound identification of needles and needle tips relative to prostate. All measurements and comparisons of measurements pertain to the day of the procedure.
10. Eligibility
Sex
Male
Minimum Age & Unit of Time
45 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Patients must have histologically proven adenocarcinoma of the prostate.
Patients must have intermediate risk prostate cancer. (Clinical stage ≤ T2c, Gleason score = 7 and initial prostate specific antigen (iPSA) ≤ 20, or Gleason score ≤ 6 and iPSA > 10 and ≤ 20.
Patients must be fit for general or spinal anaesthetic.
Patients must have an estimated life expectancy of at least 10 years.
Patients must have an Eastern Cooperative Oncology Group (ECOG) performance status of 0 - 2.
Patients must have no contraindications to interstitial prostate brachytherapy.
Patients on coumadin therapy must be able to stop therapy safely for at least 7 days.
Exclusion Criteria:
Men not able to fully understand the trial and the informed consent document
Men suffering from claustrophobia and unable to have a Computed Tomography scan
Men not wishing to have a cone-beam Computed Tomography scan following the insertion of the High Dose Rate brachytherapy needles to verify the accuracy of the treatment plan
Men who cannot safely discontinue blood thinners for a few days.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Matthew Schmid, MSc
Organizational Affiliation
British Columbia Cancer Agency Dept of Radiation Physics
Official's Role
Study Director
Facility Information:
Facility Name
BCCA Center for the Southern Interior
City
Kelowna
State/Province
British Columbia
ZIP/Postal Code
V1Y 5L3
Country
Canada
12. IPD Sharing Statement
Learn more about this trial
CT-validation of Ultrasound Based Planning for High Dose Rate (HDR) Prostate Brachytherapy Using Vitesse
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