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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01248741
Recruitment Status : Completed
First Posted : November 25, 2010
Last Update Posted : February 12, 2013
Information provided by (Responsible Party):
Juanita Crook, British Columbia Cancer Agency

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 15 men. Treatment will be planned with TransRectal UltraSound but validated pre-treatment using Computed Tomography imaging.

Condition or disease Intervention/treatment Phase
Prostate Cancer Interstitial Radiation High Dose Rate Brachytherapy Ultrasound-based Planning Compared to CT-based Planning Radiation: HDR prostate brachytherapy Phase 2

Detailed Description:
Fifteen 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  (Clinical Trial)
Actual Enrollment : 25 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: High Dose Rate (HDR)Prostate Brachytherapy With Vitesse tm
Study Start Date : December 2010
Actual Primary Completion Date : April 2012
Actual Study Completion Date : May 2012

Resource links provided by the National Library of Medicine

MedlinePlus related topics: CT Scans Ultrasound
U.S. FDA Resources

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

Primary Outcome Measures :
  1. Quality assessment of TransRectal Ultra-sound based plan for High Dose Rate prostate brachytherapy compared to Computed Tomography-derived plan [ Time Frame: 6 weeks ]
    The dosimetric quantifiers (V100: percentage of prostate volume covered by 100% prescription isodose, V150: percentage of prostate volume enclosed by 150% of prescription dose, urethral dose and rectal dose)will be used to determine differences between Ultra-sound based plan and the standard Computed Tomography-image based plan

Secondary Outcome Measures :
  1. Accuracy of needle tip identification on TransRectal UltraSound compared to Computed Tomography [ Time Frame: 6 weeks ]
    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-based and Computed Tomography-based plans.

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Ages Eligible for Study:   45 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No

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 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01248741

Canada, British Columbia
BCCA Center for the Southern Interior
Kelowna, British Columbia, Canada, V1Y 5L3
Sponsors and Collaborators
British Columbia Cancer Agency
Study Director: Matthew Schmid, MSc British Columbia Cancer Agency Dept of Radiation Physics

Responsible Party: Juanita Crook, MD FRCPC, British Columbia Cancer Agency Identifier: NCT01248741     History of Changes
Other Study ID Numbers: H10-01987
First Posted: November 25, 2010    Key Record Dates
Last Update Posted: February 12, 2013
Last Verified: February 2013

Keywords provided by Juanita Crook, British Columbia Cancer Agency:
prostate cancer
interstitial radiation,

Additional relevant MeSH terms:
Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Genital Diseases, Male
Prostatic Diseases