Prostate CancerNCT00242112
Defining the Extent and Grade of Prostate Cancer Using Dynamic Contrast Enhanced Diffusion Weighted and BOLD MRI
A study testing MRI Prostate in people with Prostate Cancer, run by University Health Network, Toronto at 1 site in Canada.
Trial summary
The purpose of this study is to determine the ability of functional MRI techniques to detect, measure and locate intra-prostatic cancer. 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?
- MRI Prostate
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 31 participants
- Where
- 1 siteCanada
- Study dates
- Jun 2005to Feb 2008
- 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
Patients will be recruited from the University Health Network (UHN). Eligible patients will be undergoing radical prostatectomy for prostate cancer at UHN. Patients with a contraindication to MRI or MRI contrast agents, claustrophobia, renal failure, allergy to MRI contrast agents, or prior hormonal therapy or radiation therapy for prostate cancer, a biopsy within 3 weeks of the surgical date or active prostatitis will be excluded.
Trial locations and contacts
1 site in 1 country.
Canada1 site
University Health Network, Princess Margaret Hospital
Toronto, Ontario, M5G 2M9
About this study
The purpose of this study is to determine the ability of functional MRI techniques to detect, measure and locate intra-prostatic cancer.
Read the detailed description
The purpose of this study is to determine the ability of functional MRI techniques [High Resolution Dynamic Contrast Enhanced MRI (HR-DCE-MRI), diffusion weighted MRI (DWI) and BOLD MRI] to detect, measure and locate intra-prostatic cancer. 70 patients undergoing MRI for staging of prostate cancer prior to radical prostatectomy will be studied. Results of MRI obtained prior to surgery will be correlated with pathologic specimens to determine MRI accuracy.
- Conditions
- Prostate Cancer
- Being tested
- MRI Prostate
- Medical subject headings
- Prostatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MRI ProstateProcedure or surgery
| Study group | Role | What they receive |
|---|---|---|
| MRI - pathology | Other | Not described Receives: Procedure: MRI Prostate |
What is being measured
The primary outcome is the main question the study is designed to answer.
Extent and Grade of Prostate Cancer Using MRI
Before undergoing surgery, all patients were examined with MR imaging
Measured: Imaging followed by pathology analysis
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Oct 2005 (estimated)
- Study startJun 2005
- Primary completionFeb 2008
- Study completionFeb 2008
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
- 31 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Health Network, Toronto
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Masoom Haider, MD, Principal investigator, University Health Network, Toronto
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00242112
- Sponsor's protocol ID
- 05-0387-CE
- Status last verified
- Apr 2017
- First submitted
- 18 Oct 2005
- Last updated
- 26 Apr 2017
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Apr 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Defining the Extent and Grade of Prostate Cancer Using Dynamic Contrast Enhanced Diffusion Weighted and BOLD MRI
- ClinicalTrials.gov ID
- NCT00242112
- Acronym / sponsor ID
- 05-0387-CE
- Conditions
- Prostate Cancer
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 31 participants (actual)
- Lead sponsor
- University Health Network, TorontoUniversity, hospital or other
- Study start
- Jun 2005
- Primary completion
- Feb 2008 (actual)
- Study completion
- Feb 2008 (actual)
- First posted
- 19 Oct 2005 (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.
The purpose of this study is to determine the ability of functional MRI techniques to detect, measure and locate intra-prostatic cancer.
Detailed description
The purpose of this study is to determine the ability of functional MRI techniques [High Resolution Dynamic Contrast Enhanced MRI (HR-DCE-MRI), diffusion weighted MRI (DWI) and BOLD MRI] to detect, measure and locate intra-prostatic cancer. 70 patients undergoing MRI for staging of prostate cancer prior to radical prostatectomy will be studied. Results of MRI obtained prior to surgery will be correlated with pathologic specimens to determine MRI accuracy.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| MRI - pathology | Other | Procedure: MRI Prostate |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
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 |
|---|---|---|
| MRI Prostate | Procedure or surgery | MRI - pathology |
Primary outcome
Extent and Grade of Prostate Cancer Using MRI
Time frame: Imaging followed by pathology analysis
Before undergoing surgery, all patients were examined with MR imaging
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 26 Apr 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.
Masoom Haider, MD principal investigator
University Health Network, Toronto
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing MRI Prostate 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?
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 26 Apr 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?
Extent and Grade of Prostate Cancer Using MRI (time frame: Imaging followed by pathology analysis). 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 26 Apr 2017.