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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.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts
Official record
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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.

Greg J Stanisz, PhD contact

416-480-5725

greg.stanisz@utoronto.ca

Canada1 site
  • Sunnybrook Health Sciences Centre

    Toronto, Ontario, M4N 3M5

    Greg J Stanisz, PhD

    Christopher Lim, MD

Other trials in Canada

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:

  1. Chemical Exchange Saturation Transfer (CEST) to probe changes in tumour metabolism.
  2. 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.

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 groups in NCT07785024
Study groupRoleWhat they receive
Diagnostic Test: Saturation Transfer (ST)-MRIExperimentalNon-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.

  1. 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)
  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.

  1. First posted25 Aug 2026
  2. Study startSep 2026 (estimated)
  3. Primary completionSep 2027 (estimated)
  4. Study completionSep 2027 (estimated)

Resources

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)
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

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.

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