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Could MRI spot prostate cancer earlier in High-Risk men?

NCT ID NCT01990521

Diagnosis Sponsor: Toronto Sunnybrook Regional Cancer Centre Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing This study
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 24, 2026 · Last updated Jun 26, 2026 · Updated 2 times

Summary

Men with BRCA1 or BRCA2 gene mutations have a higher risk of early and aggressive prostate cancer. This study tests whether using a special MRI (multispectral 3T MRI) can find prostate cancer earlier than standard PSA and digital rectal exams. Sixty men aged 50 and older with BRCA mutations will get an MRI followed by a biopsy to see how well the MRI detects cancer.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Multispectral 3T MRI and transrectal ultrasound-guided biopsy
What this could lead to
If successful, MRI could become a standard screening tool to catch prostate cancer earlier in men with BRCA mutations, potentially improving outcomes.
What could go wrong
This is a small, early study (60 participants) and it's unclear if MRI will be more effective than current PSA and DRE screening. The results may not apply to all men with BRCA mutations.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

About 60 people

The number the study aims to enrol. It can still change while the study runs.

Started

Jan 2014

Expected to finish

Sep 2026

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

50 years and older

Sex

Male participants only

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * Enrolled in the Male Hereditary Cancer Research Program at Sunnybrook Health Sciences Center. * Have positive genetic testing for a pathogenic BRCA1 or BRCA2 mutation. * Clinically eligible for and willing to undergo ultrasound biopsy within 4 weeks after the MRI. * Be 50 years of age or older. Exclusion Criteria: * Claustrophobia * Contraindication to MRI * Contraindication to receiving low molecular weight MRI contrast agent * Previously diagnosed with prostate cancer

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Conditions

The condition(s) this trial relates to.

prostate cancer prevention target

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Prostate cancer

Contacts and locations

Locations

  • Sunnybrook Odette Cancer Centre

    Toronto, Ontario, M4N 3M5, Canada

More trials for these conditions

Other studies related to the condition(s) this trial covers.