Screening for Prostate Cancer Using High Resolution Micro-ultrasound Versus Multiparametric Magnetic Resonance Imaging.
Recruiting
Phase 3
Interventional Study
Prostate Cancer Screening
No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
Pivotal Trial
This treatment is in the last trial phase before FDA approval.
Prior Safety Data
This treatment has already been tested in at least one earlier human trial.
Healthy Volunteers Welcome
You do not need to have the condition being studied to take part.
At a Glance
- Age
- 50 – 70
- Sex
- Male
- Trial phase
- Phase 3
- Study type
- Interventional
- Purpose
- Screening
- Participants needed
- 1,284 (estimated)
- Sponsor
- University of Alberta · Other
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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…
Trial Locations
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Eligibility Criteria
Inclusion Criteria:
1. Male sex;
2. Age 50-70;
3. PSA 3-20 and/or abnormal DRE;
4. Biopsy naïve.
Exclusion Criteria:
1. Prior personal history of prostate cancer;
2. Prior prostate imaging using microUS or MRI;
3. Contraindication to microUS or MRI;
4. Testosterone replacement therapy within last…
Contacts