N/A
N=130
Evaluation of Diagnostic Value of 3-T Magnetic Resonance Imaging (MRI) in Suspected Prostate Cancer
Prostatic Neoplasms
Bottom Line
View on ClinicalTrials.gov: NCT01357512 ↗Enrolled (actual)
130
Serious AEs
0.0%
Results posted
Jun 2015
Primary outcome: Primary: Number of Prostate Cancer Diagnoses in MRI and no MRI Groups — 34; 34 participants
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- magnetic resonance imaging, Siemens (Device)
- Age
- Adult, Older Adult · 40+ yrs
- Sex
- Male
- Sponsor
- University of Oulu
- Primary completion
- Dec 2014
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Prostate Cancer Diagnoses in MRI and no MRI Groups |
34; 34 | — |
| SECONDARY Number of Positive Biopsies in MRI and no MRI Groups |
3.0; 3.0 | — |
| SECONDARY Proportion of Clinically Significant Prostate Cancers Detected in MRI and no MRI Groups |
— | — |
Summary
The purpose of the study is to evaluate the usefulness of 3-T magnetic resonance imaging (MRI) in the evaluation of suspected prostate cancer. Men with suspected prostate cancer based on serum prostate-specific antigen antigen (PSA) value are included. Men are randomized to pre-biopsy MRI or no MRI groups in ratio 1:1. Standard transrectal ultrasound guided biopsies will be taken in addition to extra biopsies from lesions suspicious based on MRI evaluation. Hypothesis is that more prostate cancers will be found after MRI evaluation.
Eligibility Criteria
Inclusion Criteria
- Informed consent
- Suspected prostate cancer based on PSA value (total PSA 2,5-10 ng/ml and PSA free to total ratio 30
Data sourced from ClinicalTrials.gov (NCT01357512). 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.