Prostate CancerNCT01878773
Prostate Delineation: High Quality Volume CT
A study testing High Quality Volume CT Scan; MRI Scan in people with Prostate Cancer, run by University Health Network, Toronto at 1 site in Canada.
Trial summary
This study will look at how feasible it is to use a certain type of Computed Tomography (CT) to scan prostate cancer, called a high quality volume CT scan. It is hoped that this technique will help doctors provide a higher-quality image of the prostate cancer, making it easier to plan the area that will be treated. Read more about this study
- Who is it for?
- Ages 18 years and older, men only
- Conditions the study is for
- Prostate Cancer
- What is being tested?
- High Quality Volume CT Scan; MRI Scan
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteCanada
- Study dates
- Oct 2012to 11 Aug 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 18 years and older
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- At least 18 years old
- Subjects undergoing radical external beam radiotherapy for prostate cancer
- Ability to provide written informed consent
Who cannot join
- Age ≤ 18 years
- Subjects not suitable for MRI scanning
- 3 usable image sets not obtained during treatment planning scans.
Trial locations and contacts
1 site in 1 country.
Canada1 site
University Health Network, The Princess Margaret
Toronto, Ontario, M5G 2M9
About this study
Official title: Prostate Delineation During Radiation Treatment Planning for Prostate Cancer: Comparison of High Quality Volume Computerized Tomography With Conventional Tomography and Magnetic Resonance Imaging
This study will look at how feasible it is to use a certain type of Computed Tomography (CT) to scan prostate cancer, called a high quality volume CT scan. It is hoped that this technique will help doctors provide a higher-quality image of the prostate cancer, making it easier to plan the area that will be treated. Using this type of CT scan will also lessen the amount of time patients spend in the scanner.
This study will not offer patients a different treatment for their prostate cancer. Patients will receive the most appropriate standard treatment whether or not they are in this study.
- Conditions
- Prostate Cancer
- Being tested
- High Quality Volume CT Scan; MRI Scan
- Keywords
- Prostate Cancer, MRI scan, External beam radiotherapy
- Medical subject headings
- Prostatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
High Quality Volume CT Scan; MRI ScanOther
Patients will have the High Quality volume CT scan immediately after their CT scan followed by MRI scan.
--------------------------------------------------------------------------------
| Study group | Role | What they receive |
|---|---|---|
| High Quality Volume CT Scan; MRI Scan | Other | Patients will have the High Quality volume CT scan immediately after their CT scan followed by MRI Scan. Receives: Other: High Quality Volume CT Scan; MRI Scan |
What is being measured
The primary outcome is the main question the study is designed to answer.
Using different scanning methods for patients undergoing radical external beam radiotherapy for prostate cancer to determine inter-observer variability in prostate gland delineation on the images.
Measured: 6 months
Secondary outcomes (1)
Determine the concordance between delineators in identifying the prostate apex on the 2 CT image sets. MRI will be considered the "gold-standard" for identifying the prostate apex.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jun 2013 (estimated)
- Study startOct 2012
- Primary completion11 Aug 2017
- Study completion11 Aug 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Prostate CancerStudies of the same condition, open and under way.
- More trials run by University Health Network, TorontoThe 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
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Health Network, Toronto
- Sponsor type
- University, hospital or other
- Collaborators
- Princess Margaret Hospital, Canada
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01878773
- Sponsor's protocol ID
- UHN REB 12-5229-CE
- Status last verified
- Aug 2017
- First submitted
- 24 Oct 2012
- Last updated
- 22 Aug 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Aug 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prostate Delineation During Radiation Treatment Planning for Prostate Cancer: Comparison of High Quality Volume Computerized Tomography With Conventional Tomography and Magnetic Resonance Imaging
- ClinicalTrials.gov ID
- NCT01878773
- Acronym / sponsor ID
- UHN REB 12-5229-CE
- Conditions
- Prostate Cancer
- Keywords
- Prostate Cancer, MRI scan, External beam radiotherapy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- University Health Network, TorontoUniversity, hospital or other
- Collaborators
- Princess Margaret Hospital, Canada
- Study start
- Oct 2012
- Primary completion
- 11 Aug 2017 (actual)
- Study completion
- 11 Aug 2017 (actual)
- First posted
- 17 Jun 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study will look at how feasible it is to use a certain type of Computed Tomography (CT) to scan prostate cancer, called a high quality volume CT scan. It is hoped that this technique will help doctors provide a higher-quality image of the prostate cancer, making it easier to plan the area that will be treated. Using this type of CT scan will also lessen the amount of time patients spend in the scanner.
This study will not offer patients a different treatment for their prostate cancer. Patients will receive the most appropriate standard treatment whether or not they are in this study.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| High Quality Volume CT Scan; MRI Scan | Other | Other: High Quality Volume CT Scan; MRI ScanPatients will have the High Quality volume CT scan immediately after their CT scan followed by MRI Scan. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- At least 18 years old
- Subjects undergoing radical external beam radiotherapy for prostate cancer
- Ability to provide written informed consent
Key exclusion criteria (3 listed)
- Age ≤ 18 years
- Subjects not suitable for MRI scanning
- 3 usable image sets not obtained during treatment planning scans.
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 |
|---|---|---|
| High Quality Volume CT Scan; MRI ScanPatients will have the High Quality volume CT scan immediately after their CT scan followed by MRI scan. -------------------------------------------------------------------------------- | Other | High Quality Volume CT Scan; MRI Scan |
Primary outcome
Using different scanning methods for patients undergoing radical external beam radiotherapy for prostate cancer to determine inter-observer variability in prostate gland delineation on the images.
Time frame: 6 months
1 secondary outcome
Determine the concordance between delineators in identifying the prostate apex on the 2 CT image sets. MRI will be considered the "gold-standard" for identifying the prostate apex.
Time frame: 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Aug 2017.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing High Quality Volume CT Scan; MRI Scan in people with Prostate Cancer, run by University Health Network, Toronto 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 3 inclusion and 3 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 22 Aug 2017. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Using different scanning methods for patients undergoing radical external beam radiotherapy for prostate cancer to determine inter-observer variability in prostate gland delineation on the images. (time frame: 6 months). 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 22 Aug 2017; AzTrials last refreshed its copy on 26 Oct 2026.