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High Dose Rate (HDR)Prostate Brachytherapy With Vitesse tm

Phase 2
45 Years
80 Years
Not Enrolling
Prostate Cancer, Interstitial Radiation, High Dose Rate Brachytherapy, Ultrasound-based Planning Compared to CT-based Planning

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Trial Information

High Dose Rate (HDR)Prostate Brachytherapy With Vitesse tm

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

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

- Men who cannot safely discontinue blood thinners for a few days.

Type of Study:


Study Design:

Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Quality assessment of TransRectal Ultra-sound based plan for High Dose Rate prostate brachytherapy compared to Computed Tomography-derived plan

Outcome Description:

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

Outcome Time Frame:

6 weeks

Safety Issue:


Principal Investigator

Matthew Schmid, MSc

Investigator Role:

Study Director

Investigator Affiliation:

British Columbia Cancer Agency Dept of Radiation Physics


Canada: Health Canada

Study ID:




Start Date:

December 2010

Completion Date:

May 2012

Related Keywords:

  • Prostate Cancer
  • Interstitial Radiation
  • High Dose Rate Brachytherapy
  • Ultrasound-based Planning Compared to CT-based Planning
  • prostate cancer
  • interstitial radiation,
  • brachytherapy
  • Prostatic Neoplasms