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

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.

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Key information

Conditions

Prostate Cancer Genital Diseases Genital Diseases, Male Genital Neoplasms, Male High Dose Rate Brachytherapy Interstitial Radiation Male Urogenital Diseases Neoplasms Neoplasms by Site Prostatic Diseases Prostatic Neoplasms Ultrasound-based Planning Compared to CT-based Planning Urogenital Diseases Urogenital Neoplasms

Age range

45 year–80 year

Sex eligibility

Male

Study type

Interventional

Phase

Not applicable

Primary location

BCCA Center for the Southern Interior

Kelowna, British Columbia, V1Y 5L3, Canada

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

HDR prostate brachytherapy

Radiation

HDR prostate brachytherapy to be delivered in 2 fractions of 10 Gray as a "boost" combined with external beam radiotherapy

Primary outcomes

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.

Sponsors and collaborators

Lead sponsor

British Columbia Cancer Agency

Other

Registry information

Official study title

High Dose Rate (HDR)Prostate Brachytherapy With Vitesse tm

Acronym: Vitesse

Important dates

Study start: 2010
Primary completion: 2012
Study completion: 2012
First posted: Nov 25, 2010
Registry last updated: Dec 11, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed