Prostate CancerVitesseNCT01248741
CT-validation of Ultrasound Based Planning for High Dose Rate (HDR) Prostate Brachytherapy Using Vitesse
A study testing HDR prostate brachytherapy in people with Prostate Cancer and Interstitial Radiation, run by British Columbia Cancer Agency at 1 site in Canada.
Trial 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. Read more about this study
- Who is it for?
- Ages 45 to 80 years, men only
- Conditions the study is for
- Prostate Cancer, Interstitial Radiation, High Dose Rate Brachytherapy
- What is being tested?
- HDR prostate brachytherapy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteCanada
- Study dates
- Dec 2010to May 2012
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 45 to 80 years
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Canada1 site
BCCA Center for the Southern Interior
Kelowna, British Columbia, V1Y 5L3
About this study
Official title: High Dose Rate (HDR)Prostate Brachytherapy With Vitesse tm
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.
Read the detailed description
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
- Prostate Cancer, Interstitial Radiation, High Dose Rate Brachytherapy, Ultrasound-based Planning Compared to CT-based Planning
- Being tested
- HDR prostate brachytherapy
- Keywords
- prostate cancer, interstitial radiation,, brachytherapy
- Medical subject headings
- Prostatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HDR prostate brachytherapyRadiation
HDR prostate brachytherapy to be delivered in 2 fractions of 10 Gray as a "boost" combined with external beam radiotherapy
| Study group | Role | What they receive |
|---|---|---|
| HDR prostate brachytherapy | Experimental | 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. Receives: Radiation: HDR prostate brachytherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Accuracy of Needle Tip Identification on TransRectal UltraSound Compared to Computed Tomography
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.
Measured: 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.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Nov 2010 (estimated)
- Study startDec 2010
- Primary completionApr 2012
- Study completionMay 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Prostate CancerStudies of the same condition, open and under way.
- More trials run by British Columbia Cancer AgencyThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- British Columbia Cancer Agency
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Juanita Crook, British Columbia Cancer Agency
- Investigators
- Matthew Schmid, MSc, Study director, British Columbia Cancer Agency Dept of Radiation Physics
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01248741
- Sponsor's protocol ID
- H10-01987
- Acronym
- Vitesse
- Status last verified
- Nov 2020
- First submitted
- 3 Nov 2010
- Last updated
- 11 Dec 2020
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Dec 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- High Dose Rate (HDR)Prostate Brachytherapy With Vitesse tm
- ClinicalTrials.gov ID
- NCT01248741
- Acronym / sponsor ID
- Vitesse / H10-01987
- Conditions
- Prostate Cancer, Interstitial Radiation, High Dose Rate Brachytherapy, Ultrasound-based Planning Compared to CT-based Planning
- Keywords
- prostate cancer, interstitial radiation,, brachytherapy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- British Columbia Cancer AgencyUniversity, hospital or other
- Study start
- Dec 2010
- Primary completion
- Apr 2012 (actual)
- Study completion
- May 2012 (actual)
- First posted
- 25 Nov 2010 (estimated)
- Results
- Posted 11 Dec 2020
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| HDR prostate brachytherapy | Experimental | Radiation: HDR prostate brachytherapyAn 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. |
Who may qualify
- Ages
- 45 to 80 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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.
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| HDR prostate brachytherapyHDR prostate brachytherapy to be delivered in 2 fractions of 10 Gray as a "boost" combined with external beam radiotherapy | Radiation | HDR prostate brachytherapy |
Primary outcome
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.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Dec 2020.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Matthew Schmid, MSc study director
British Columbia Cancer Agency Dept of Radiation Physics
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing HDR prostate brachytherapy in people with Prostate Cancer and Interstitial Radiation, run by British Columbia Cancer Agency at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 Dec 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 11 Dec 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Dec 2020.