Prostate Cancer DetectionNCT07785024
CEST for Prostate Biopsy
A study testing Biopsy-Guided Therapy Selection in people with Prostate Cancer Detection, run by Sunnybrook Health Sciences Centre at 1 site in Canada.
Trial summary
Samples of prostate tissue acquired by biopsy to determine whether there is cancer will sometimes not find cancer that is present. Conventionally, magnetic resonance imaging (MRI) is used to identify 12 areas to biopsy. Read more about this study
- Who is it for?
- Ages 18 years and older, men only
- Conditions the study is for
- Prostate Cancer Detection
- What is being tested?
- Biopsy-Guided Therapy Selection
- 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
- Sep 2026to Sep 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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
- PI-RADS category 3 prostate cancer with upcoming targeted biopsy
Who cannot join
- Contraindications to MRI
- Prior radiotherapy
- Prior chemotherapy
- Prior prostate biopsy
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Canada1 site
Sunnybrook Health Sciences Centre
Toronto, Ontario, M4N 3M5
Greg J Stanisz, PhD
Christopher Lim, MD
About this study
Official title: Advanced Metabolic MRI to Refine Targeted Prostate Biopsy
Samples of prostate tissue acquired by biopsy to determine whether there is cancer will sometimes not find cancer that is present. Conventionally, magnetic resonance imaging (MRI) is used to identify 12 areas to biopsy. We will use an advanced MRI method called magnetization transfer (MT) and chemical exchange saturation transfer (CEST) imaging to suggest two additional biopsy location. Our objectives are to determine 1) whether MT/CEST MRI can aid in the detection prostate cancer and 2) whether MT/CEST MRI can aid conventional MRI in risk stratification and to decide whether targeted prostate biopsy is justified.
Read the detailed description
Prostate Imaging and Data Reporting System assessment categories positively correlate with an increased likelihood of detecting clinically significant prostate cancer (csPCa) at targeted biopsy1. A PI-RADS assessment category 3 (intermediate, clinically significant cancer likelihood equivocal) lesion is often not csPCa. Studies evaluating the likelihood of csPCa cancer at targeted biopsy of PI-RADS category 3 lesions have reported variable rates of PCa diagnosis, ranging from 5-30%, with the majority of studies showing a relatively low likelihood of eventual csPCa diagnosis2-4. Management of PI-RADS category 3 lesion is variable, ranging from immediate biopsy to surveillance5,6. Given the disparity in management patterns for PI-RADS category 3 lesions and a small but not insignificant proportion of these lesions harboring csPCa, better classification of category 3 lesion is an unmet need. Previous studies in these patients have shown a correlation of csPCa with older patient age, smaller prostate volumes, higher prostate-specific antigen density (PSAD), and increased clinical stage7-11.
In this study, we will investigate the ability of magnetization transfer (MT) and chemical exchange saturation transfer (CEST) magnetic resonance imaging (MRI), without the use of any injected contrast agent, in conjunction with multiparametric magnetic resonance imaging (mpMRI) to aid in the detection of cancer, risk stratification and to decide whether a targeted prostate biopsy is justified. In this study, we propose to use the following ST-MRI techniques:
- Chemical Exchange Saturation Transfer (CEST) to probe changes in tumour metabolism.
- Magnetization Transfer (MT) to evaluate tumour environment microstructure.
Up to five healthy volunteers will be recruited for ST-MRI testing and estimation of test/re-test reproducibility. Testing of MR imaging protocols on healthy volunteers (without contrast agent) is required for optimization of sequence parameters including: higher signal intensity, higher contrast between tissue types, decreased scan time, and reduced image artifacts. There will be up to three MRI scans per healthy volunteer. MRI contrast agent will not be injected.
Patient recruitment will be performed at the Odette Cancer Centre. There will be one MRI scan per patient. All patients will undergo ST-MRI scans at Sunnybrook. ST-MRI parameter images including MTR, AREX, and quantitative MT model parameters, in addition to quantitative magnetization relaxation images will be used to identify areas of prostate with altered image contrast. Other quantitative and semiquantitative features will also be evaluated from the images. We hypothesize that ST-MRI will identify cancer suspicious areas that overlap with those identified by mpMRI and potentially additional areas.
- Conditions
- Prostate Cancer Detection
- Being tested
- Biopsy-Guided Therapy Selection
- Keywords
- biopsy, MRI, saturation transfer, PI-RADS, chemical exchange saturation transfer, magnetization transfer
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Biopsy-Guided Therapy SelectionProcedure or surgery
Saturation transfer MRI (chemical exchange saturation transfer and magnetization transfer) used to identify two additional biopsy locations in addition to those identified by conventional MRI.
| Study group | Role | What they receive |
|---|---|---|
| Diagnostic Test: Saturation Transfer (ST)-MRI | Experimental | Non-contrast magnetic resonance imaging "Saturation Transfer" scans consisting of magnetization transfer (MT) and chemical exchange saturation transfer (CEST) Receives: Procedure: Biopsy-Guided Therapy Selection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Aiding the detection of prostate cancer
To determine whether MT/CEST MRI can aid in the detection of prostate cancer. The histopathological detection of cancer in biopsy cores will serve as a measure of outcome to which the MT/CEST MRI parameter and relaxation images will be compared.
Measured: 1 year
Secondary outcomes (1)
Aiding risk stratification and the decision whether targeted prostate biopsy is justified
To determine whether MT/CEST MRI can aid multiparametric MRI (mpMRI) in risk stratification and to decide whether targeted prostate biopsy is justified. The presence of cancer detected histopathologically in biopsy locations suggested by MT/CEST MRI, but not chosen for biopsy by convention mpMRI will serve as a measure of outcome.
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Aug 2026
- Study startSep 2026 (estimated)
- Primary completionSep 2027 (estimated)
- Study completionSep 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Prostate Cancer DetectionStudies 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
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sunnybrook Health Sciences Centre
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Greg J Stanisz, PhD, Principal investigator, Sunnybrook Research InstituteChristopher Lim, MD, Principal investigator, Sunnybrook Health Sciences CentreDanny Vesprini, MSc, MD, Principal investigator, Sunnybrook Health Sciences CentreStanley K Liu, MD, PhD, Principal investigator, Sunnybrook Health Sciences Centre
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07785024
- Sponsor's protocol ID
- 7378
- Status last verified
- Aug 2026
- First submitted
- 19 Aug 2026
- Last updated
- 25 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Advanced Metabolic MRI to Refine Targeted Prostate Biopsy
- ClinicalTrials.gov ID
- NCT07785024
- Acronym / sponsor ID
- 7378
- Conditions
- Prostate Cancer Detection
- Keywords
- biopsy, MRI, saturation transfer, PI-RADS, chemical exchange saturation transfer, magnetization transfer
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Sunnybrook Health Sciences CentreUniversity, hospital or other
- Study start
- Sep 2026 (estimated)
- Primary completion
- Sep 2027 (estimated)
- Study completion
- Sep 2027 (estimated)
- First posted
- 25 Aug 2026 (actual)
- 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.
Samples of prostate tissue acquired by biopsy to determine whether there is cancer will sometimes not find cancer that is present. Conventionally, magnetic resonance imaging (MRI) is used to identify 12 areas to biopsy. We will use an advanced MRI method called magnetization transfer (MT) and chemical exchange saturation transfer (CEST) imaging to suggest two additional biopsy location. Our objectives are to determine 1) whether MT/CEST MRI can aid in the detection prostate cancer and 2) whether MT/CEST MRI can aid conventional MRI in risk stratification and to decide whether targeted prostate biopsy is justified.
Detailed description
Prostate Imaging and Data Reporting System assessment categories positively correlate with an increased likelihood of detecting clinically significant prostate cancer (csPCa) at targeted biopsy1. A PI-RADS assessment category 3 (intermediate, clinically significant cancer likelihood equivocal) lesion is often not csPCa. Studies evaluating the likelihood of csPCa cancer at targeted biopsy of PI-RADS category 3 lesions have reported variable rates of PCa diagnosis, ranging from 5-30%, with the majority of studies showing a relatively low likelihood of eventual csPCa diagnosis2-4. Management of PI-RADS category 3 lesion is variable, ranging from immediate biopsy to surveillance5,6. Given the disparity in management patterns for PI-RADS category 3 lesions and a small but not insignificant proportion of these lesions harboring csPCa, better classification of category 3 lesion is an unmet need. Previous studies in these patients have shown a correlation of csPCa with older patient age, smaller prostate volumes, higher prostate-specific antigen density (PSAD), and increased clinical stage7-11.
In this study, we will investigate the ability of magnetization transfer (MT) and chemical exchange saturation transfer (CEST) magnetic resonance imaging (MRI), without the use of any injected contrast agent, in conjunction with multiparametric magnetic resonance imaging (mpMRI) to aid in the detection of cancer, risk stratification and to decide whether a targeted prostate biopsy is justified. In this study, we propose to use the following ST-MRI techniques:
- Chemical Exchange Saturation Transfer (CEST) to probe changes in tumour metabolism.
- Magnetization Transfer (MT) to evaluate tumour environment microstructure.
Up to five healthy volunteers will be recruited for ST-MRI testing and estimation of test/re-test reproducibility. Testing of MR imaging protocols on healthy volunteers (without contrast agent) is required for optimization of sequence parameters including: higher signal intensity, higher contrast between tissue types, decreased scan time, and reduced image artifacts. There will be up to three MRI scans per healthy volunteer. MRI contrast agent will not be injected.
Patient recruitment will be performed at the Odette Cancer Centre. There will be one MRI scan per patient. All patients will undergo ST-MRI scans at Sunnybrook. ST-MRI parameter images including MTR, AREX, and quantitative MT model parameters, in addition to quantitative magnetization relaxation images will be used to identify areas of prostate with altered image contrast. Other quantitative and semiquantitative features will also be evaluated from the images. We hypothesize that ST-MRI will identify cancer suspicious areas that overlap with those identified by mpMRI and potentially additional areas.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Diagnostic Test: Saturation Transfer (ST)-MRI | Experimental | Procedure: Biopsy-Guided Therapy SelectionNon-contrast magnetic resonance imaging "Saturation Transfer" scans consisting of magnetization transfer (MT) and chemical exchange saturation transfer (CEST) |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- PI-RADS category 3 prostate cancer with upcoming targeted biopsy
Key exclusion criteria (4 listed)
- Contraindications to MRI
- Prior radiotherapy
- Prior chemotherapy
- Prior prostate biopsy
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 |
|---|---|---|
| Biopsy-Guided Therapy SelectionSaturation transfer MRI (chemical exchange saturation transfer and magnetization transfer) used to identify two additional biopsy locations in addition to those identified by conventional MRI. | Procedure or surgery | Diagnostic Test: Saturation Transfer (ST)-MRI |
Primary outcome
Aiding the detection of prostate cancer
Time frame: 1 year
To determine whether MT/CEST MRI can aid in the detection of prostate cancer. The histopathological detection of cancer in biopsy cores will serve as a measure of outcome to which the MT/CEST MRI parameter and relaxation images will be compared.
1 secondary outcome
Aiding risk stratification and the decision whether targeted prostate biopsy is justified
Time frame: 1 year
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Aug 2026.
- Individual participant dataSharing planned: No
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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.
Greg J Stanisz, PhD principal investigator
Sunnybrook Research Institute
Christopher Lim, MD principal investigator
Sunnybrook Health Sciences Centre
Danny Vesprini, MSc, MD principal investigator
Sunnybrook Health Sciences Centre
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Biopsy-Guided Therapy Selection in people with Prostate Cancer Detection, 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 1 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: opening soon, as of the sponsor's last update on 25 Aug 2026. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Greg J Stanisz, PhD (416-480-5725, greg.stanisz@utoronto.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Aiding the detection of prostate cancer (time frame: 1 year). 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 25 Aug 2026.