Screening for Prostate Cancer Using High Resolution Micro-ultrasound Versus Multiparametric Magnetic Resonance Imaging.

ConditionProstate Cancer Screening

Trial statusRecruiting

Trial phasePhase 3

Trial typeInterventional

Biological sexMale

Age50-70

SponsorUniversity of Alberta

About this trial

The purpose of this study is to compare whether the FDA and Health Canada approved microUS is as effective as the currently used option (MRI) for imaging the prostate gland. Participants will be randomized into two groups to compare the imaging results of the current standard of care MRI and the new microUS. The study is looking to identify the most effective imaging modality to help guide whether you progress to have a prostate biopsy.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

Male sex;

Age 50-70;

PSA 3-20 and/or abnormal DRE;

Biopsy naïve.

Disqualifiers

Prior personal history of prostate cancer;

Prior prostate imaging using microUS or MRI;

Contraindication to microUS or MRI;

Testosterone replacement therapy within last 12 months; or

Trial design

Design model

Parallel

Treatments tested in this trial

MRI
Device
Standard prostate mpMRI.
ExactVu
Device
microUltrasound

Treatment groups

1,284 Participants

are divided into 2 treatment groups

Group A: MRIActive comparator 1 intervention

Group B: microUltransoundExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

Detection of Clinically significant prostate cancer.

The primary objective of this trial is to determine if a screening pathway using microUS is non-inferior to a pathway using MRI for the detection of clinically significant prostate cancer, defined as Gleason Grade Group 2 or more.

Time frame

Once enrolled, men will be followed for 1 year after the imaging test.

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

University of Alberta

Lead sponsor

Source ClinicalTrials.gov

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