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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Juanita Crook, British Columbia Cancer Agency
ClinicalTrials.gov Identifier:
NCT01248741
First received: November 3, 2010
Last updated: February 8, 2013
Last verified: February 2013
  Purpose

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

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: High Dose Rate (HDR)Prostate Brachytherapy With Vitesse tm

Resource links provided by NLM:


Further study details as provided by British Columbia Cancer Agency:

Primary Outcome Measures:
  • Quality assessment of TransRectal Ultra-sound based plan for High Dose Rate prostate brachytherapy compared to Computed Tomography-derived plan [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]
    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:
  • Accuracy of needle tip identification on TransRectal UltraSound compared to Computed Tomography [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]
    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.


Enrollment: 25
Study Start Date: December 2010
Study Completion Date: May 2012
Primary Completion Date: April 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

  Eligibility

Ages Eligible for Study:   45 Years to 80 Years
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01248741

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

No publications provided

Responsible Party: Juanita Crook, MD FRCPC, British Columbia Cancer Agency
ClinicalTrials.gov Identifier: NCT01248741     History of Changes
Other Study ID Numbers: H10-01987
Study First Received: November 3, 2010
Last Updated: February 8, 2013
Health Authority: Canada: Health Canada

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

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

ClinicalTrials.gov processed this record on September 16, 2014