CT-validation of Ultrasound Based Planning for High Dose Rate (HDR) Prostate Brachytherapy Using Vitesse (Vitesse)

November 17, 2020 updated by: Juanita Crook, British Columbia Cancer Agency

High Dose Rate (HDR)Prostate Brachytherapy With Vitesse tm

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

20

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
    • British Columbia
      • Kelowna, British Columbia, Canada, V1Y 5L3
        • BCCA Center for the Southern Interior

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

45 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Male

Description

Inclusion Criteria:

  1. Patients must have histologically proven adenocarcinoma of the prostate.
  2. 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.
  3. Patients must be fit for general or spinal anaesthetic.
  4. Patients must have an estimated life expectancy of at least 10 years.
  5. Patients must have an Eastern Cooperative Oncology Group (ECOG) performance status of 0 - 2.
  6. Patients must have no contraindications to interstitial prostate brachytherapy.
  7. 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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: HDR prostate brachytherapy
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.
Radiation: HDR prostate brachytherapy
HDR prostate brachytherapy to be delivered in 2 fractions of 10 Gray as a "boost" combined with external beam radiotherapy

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Accuracy of Needle Tip Identification on TransRectal UltraSound Compared to Computed Tomography
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.
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.
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.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

British Columbia Cancer Agency

Investigators

  • Study Director: Matthew Schmid, MSc, British Columbia Cancer Agency Dept of Radiation Physics

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 2010

Primary Completion (Actual)

April 1, 2012

Study Completion (Actual)

May 1, 2012

Study Registration Dates

First Submitted

November 3, 2010

First Submitted That Met QC Criteria

November 24, 2010

First Posted (Estimate)

November 25, 2010

Study Record Updates

Last Update Posted (Actual)

December 11, 2020

Last Update Submitted That Met QC Criteria

November 17, 2020

Last Verified

November 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • H10-01987

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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