Prostate CancerNCT01896713
The Value of MultiSpectral 3 Tesla MRI in Active Surveillance of Prostate Cancer
A study testing MS3TMRI in people with Prostate Cancer, run by Sunnybrook Health Sciences Centre at 1 site in Canada.
Trial summary
MultiSpectral 3 Tesla MRI (MS3TMRI) can increase the yield of Trans Rectal Ultrasound Biopsy (TRUSBx) to improve identification of patients on active surveillance requiring treatment. 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?
- MS3TMRI
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 81 participants
- Where
- 1 siteCanada
- Study dates
- Apr 2010to Dec 2012
- 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
- Enrolled in active surveillance at Sunnybrook Health Sciences Centre, requiring biopsy as part of surveillance protocol.
- Clinically eligible for radical prostatectomy and willing to undergo surgery
- Clinically eligible for and willing to undergo ultrasound biopsy within 8 weeks of MRI
Who cannot join
- Claustrophobia
- Contraindication to MRI
- Contraindication to receiving low molecular weight MRI contrast agent
- Prior hormone therapy except 5-alpha reductase inhibitors such as Avodart. FloMax etc
- Clinically suspected or known compromised renal function or calculated estimated Glomerular Filtration Rate (eGFR) <30ml/min
Trial locations and contacts
1 site in 1 country.
About this study
Official title: To Determine if MultiSpectral 3 Tesla MRI Can Provide Added Value in the Detection of Significant Cancers in Patients o n Active Surveillance for Prostate Cancer
MultiSpectral 3 Tesla MRI (MS3TMRI) can increase the yield of Trans Rectal Ultrasound Biopsy (TRUSBx) to improve identification of patients on active surveillance requiring treatment.
Read the detailed description
This is a prospective single arm study. 120 patients at risk for significant occult prostate cancer on an active surveillance program will undergo MS3TMRI followed by a standard TRUSBx and additional biopsies guided by the MS3TMRI results. The positive predictive value (PPV) of MS3TMRI-TRUSBx for cancer requiring consideration of therapy will be compared to the PPV of TRUSBx alone. MS3TMRI consists of T2, diffusion-weighted imaging (DWI), dynamic contrast enhanced MRI (DCEMRI), proton MR spectroscopy (MRS) interpreted by a radiologist and by CAD methods validated on whole mount prostate specimens.
- Conditions
- Prostate Cancer
- Being tested
- MS3TMRI
- Keywords
- Prostate Cancer, MRI, TRUSBx
- Medical subject headings
- Prostatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MS3TMRIOther
Also called Multispectral 3 Tesla MRI imaging
Multispectral 3 Tesla MRI imaging with contrast followed by biopsy
| Study group | Role | What they receive |
|---|---|---|
| Diagnostic: Single Arm | Other | Imaging (MS3TMRI) Receives: Other: MS3TMRI |
What is being measured
The primary outcome is the main question the study is designed to answer.
The Positive Predictive Value (PPV) of MS3TMRI-TRUSBx for detection of a patient with a cancer burden requiring consideration of immediate therapy.
Compare the targeted biopsy to the random biopsies
Measured: The outcome measure will be evaluated at the time of the results of the TRUSbx which will be approximately 2 weeks after the biopsy
Secondary outcomes (1)
The number of cores required for diagnosis of prostate cancer for MS3TMRI-TRUSBx versus TRUSBx alone
Measured: The outcome measure will be evaluated at the time of the results of the TRUSbx which will be approximately 2 weeks after the biopsy
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jul 2013 (estimated)
- Study startApr 2010
- Primary completionDec 2012
- Study completionDec 2012
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 Sunnybrook Health Sciences CentreThe 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
- 81 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sunnybrook Health Sciences Centre
- Sponsor type
- University, hospital or other
- Collaborators
- Philips Healthcare
- Responsible party
- Principal investigator, Masoom Haider, Sunnybrook Health Sciences Centre
- Investigators
- Masoom Haider, MD, Principal investigator, Sunnybrook Health Sciences Centre, University of Toronto
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01896713
- Sponsor's protocol ID
- 154-2009
- Status last verified
- Jul 2013
- First submitted
- 7 Jan 2013
- Last updated
- 11 Jul 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Jul 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- To Determine if MultiSpectral 3 Tesla MRI Can Provide Added Value in the Detection of Significant Cancers in Patients o n Active Surveillance for Prostate Cancer
- ClinicalTrials.gov ID
- NCT01896713
- Acronym / sponsor ID
- 154-2009
- Conditions
- Prostate Cancer
- Keywords
- Prostate Cancer, MRI, TRUSBx
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 81 participants (actual)
- Lead sponsor
- Sunnybrook Health Sciences CentreUniversity, hospital or other
- Collaborators
- Philips Healthcare
- Study start
- Apr 2010
- Primary completion
- Dec 2012 (actual)
- Study completion
- Dec 2012 (actual)
- First posted
- 11 Jul 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.
MultiSpectral 3 Tesla MRI (MS3TMRI) can increase the yield of Trans Rectal Ultrasound Biopsy (TRUSBx) to improve identification of patients on active surveillance requiring treatment.
Detailed description
This is a prospective single arm study. 120 patients at risk for significant occult prostate cancer on an active surveillance program will undergo MS3TMRI followed by a standard TRUSBx and additional biopsies guided by the MS3TMRI results. The positive predictive value (PPV) of MS3TMRI-TRUSBx for cancer requiring consideration of therapy will be compared to the PPV of TRUSBx alone. MS3TMRI consists of T2, diffusion-weighted imaging (DWI), dynamic contrast enhanced MRI (DCEMRI), proton MR spectroscopy (MRS) interpreted by a radiologist and by CAD methods validated on whole mount prostate specimens.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Diagnostic: Single Arm | Other | Other: MS3TMRIImaging (MS3TMRI) |
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)
- Enrolled in active surveillance at Sunnybrook Health Sciences Centre, requiring biopsy as part of surveillance protocol.
- Clinically eligible for radical prostatectomy and willing to undergo surgery
- Clinically eligible for and willing to undergo ultrasound biopsy within 8 weeks of MRI
Key exclusion criteria (5 listed)
- Claustrophobia
- Contraindication to MRI
- Contraindication to receiving low molecular weight MRI contrast agent
- Prior hormone therapy except 5-alpha reductase inhibitors such as Avodart. FloMax etc
- Clinically suspected or known compromised renal function or calculated estimated Glomerular Filtration Rate (eGFR) <30ml/min
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 |
|---|---|---|
| MS3TMRIAlso: Multispectral 3 Tesla MRI imagingMultispectral 3 Tesla MRI imaging with contrast followed by biopsy | Other | Diagnostic: Single Arm |
Primary outcome
The Positive Predictive Value (PPV) of MS3TMRI-TRUSBx for detection of a patient with a cancer burden requiring consideration of immediate therapy.
Time frame: The outcome measure will be evaluated at the time of the results of the TRUSbx which will be approximately 2 weeks after the biopsy
Compare the targeted biopsy to the random biopsies
1 secondary outcome
The number of cores required for diagnosis of prostate cancer for MS3TMRI-TRUSBx versus TRUSBx alone
Time frame: The outcome measure will be evaluated at the time of the results of the TRUSbx which will be approximately 2 weeks after the biopsy
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 11 Jul 2013.
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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
Sunnybrook Health Sciences Centre, University of 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 MS3TMRI in people with Prostate Cancer, run by Sunnybrook Health Sciences Centre 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 5 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 Jul 2013. 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?
The Positive Predictive Value (PPV) of MS3TMRI-TRUSBx for detection of a patient with a cancer burden requiring consideration of immediate therapy. (time frame: The outcome measure will be evaluated at the time of the results of the TRUSbx which will be approximately 2 weeks after the biopsy). 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 Jul 2013.