NCT07785024

Brief 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. 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.

Trial Health

63
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
20

participants targeted

Target at below P25 for not_applicable

Timeline
12mo left

Started Sep 2026

Geographic Reach
1 country

1 active site

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 19, 2026

Completed
6 days until next milestone

First Posted

Study publicly available on registry

August 25, 2026

Completed
7 days until next milestone

Study Start

First participant enrolled

September 1, 2026

Expected
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2027

Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2027

Last Updated

August 25, 2026

Status Verified

August 1, 2026

Enrollment Period

1 year

First QC Date

August 19, 2026

Last Update Submit

August 19, 2026

Conditions

Keywords

biopsyMRIsaturation transferPI-RADSchemical exchange saturation transfermagnetization transfer

Outcome Measures

Primary Outcomes (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.

    1 year

Secondary Outcomes (1)

  • Aiding risk stratification and the decision whether targeted prostate biopsy is justified

    1 year

Study Arms (1)

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)

Procedure: Biopsy-Guided Therapy Selection

Interventions

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.

Diagnostic Test: Saturation Transfer (ST)-MRI

Eligibility Criteria

Age18 Years+
Sexmale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • PI-RADS category 3 prostate cancer with upcoming targeted biopsy

You may not qualify if:

  • Contraindications to MRI
  • Prior radiotherapy
  • Prior chemotherapy
  • Prior prostate biopsy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Sunnybrook Health Sciences Centre

Toronto, Ontario, M4N 3M5, Canada

Location

Study Officials

  • Greg J Stanisz, PhD

    Sunnybrook Research Institute

    PRINCIPAL INVESTIGATOR
  • Christopher Lim, MD

    Sunnybrook Health Sciences Centre

    PRINCIPAL INVESTIGATOR
  • Danny Vesprini, MSc, MD

    Sunnybrook Health Sciences Centre

    PRINCIPAL INVESTIGATOR
  • Stanley K Liu, MD, PhD

    Sunnybrook Health Sciences Centre

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Greg J Stanisz, PhD

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 19, 2026

First Posted

August 25, 2026

Study Start (Estimated)

September 1, 2026

Primary Completion (Estimated)

September 1, 2027

Study Completion (Estimated)

September 1, 2027

Last Updated

August 25, 2026

Record last verified: 2026-08

Data Sharing

IPD Sharing
Will not share

Locations