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

NCT ID: NCT01248741

Last Updated: 2020-12-11

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-12-31

Study Completion Date

2012-05-31

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Prostate Cancer Interstitial Radiation High Dose Rate Brachytherapy Ultrasound-based Planning Compared to CT-based Planning

Keywords

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prostate cancer interstitial radiation, brachytherapy

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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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.

Group Type EXPERIMENTAL

HDR prostate brachytherapy

Intervention Type RADIATION

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

Interventions

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HDR prostate brachytherapy

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

Intervention Type RADIATION

Eligibility Criteria

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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.
Minimum Eligible Age

45 Years

Maximum Eligible Age

80 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

No

Sponsors

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British Columbia Cancer Agency

OTHER

Sponsor Role lead

Responsible Party

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Juanita Crook

MD FRCPC

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Matthew Schmid, MSc

Role: STUDY_DIRECTOR

British Columbia Cancer Agency Dept of Radiation Physics

Locations

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BCCA Center for the Southern Interior

Kelowna, British Columbia, Canada

Site Status

Countries

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Canada

Other Identifiers

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H10-01987

Identifier Type: -

Identifier Source: org_study_id