N/A
N=48
Prostate Cancer Detection Screening MRI Protocol
Prostate Cancer
Bottom Line
View on ClinicalTrials.gov: NCT04175730 ↗Enrolled (actual)
48
Serious AEs
0.0%
Results posted
Jun 2022
Primary outcome: Primary: Number of Participants With Any Grade or High Grade (Gleason Score 7 or Higher) Prostate Cancer as Measured by Histopathology — 11; 8 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Ultrasound and MRI (Device); Ultrasound (Device)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- Male
- Sponsor
- University of Illinois at Chicago
- Primary completion
- Dec 2020
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants With Any Grade or High Grade (Gleason Score 7 or Higher) Prostate Cancer as Measured by Histopathology |
11; 8 | — |
| PRIMARY Number of Biopsy Samples With a Prevalence of High Grade (Gleason 7 or Higher) Prostate Cancer as Measured by Histopathology |
8; 3 | — |
| PRIMARY Number of Participants With PI-RADS 4-5 on MRI |
23; 5 | — |
| PRIMARY Number of Participants With PI-RADS <4 MRI |
4; 16 | — |
| PRIMARY Number of Participants That Had Adverse Events |
0; 0 | — |
Summary
Whether a quantitative detection specfic magnetic resonance imaging (MRI) protocol improves prostate cancer (PCa) detection in biopsy naïve men is not adequately studied.
Eligibility Criteria
Inclusion Criteria
- Adult men between 18 and 80 years of age
- Suspected PCa as defined by elevated PSA ≥4 ng/mL and ≤20 ng/mL and/or abnormal DRE as determined by a physician
- Ability to provide informed consent
Exclusion Criteria
- Prior prostate biopsy
- Prior diagnosis of PCa
- MRI incompatible implanted medical devices or foreign bodies
- Rectal anatomy incompatible with TRUS biopsy
- Life expectancy <10 years as determined by the treating urologist
Data sourced from ClinicalTrials.gov (NCT04175730). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.