N/A
N=24
Detection of Clinically Significant Prostate Cancer Using Transperineal Targeted Biopsy Compared to Standard Transrectal Biopsy
Prostate Cancer · Magnetic Resonance Imaging · Target Lesion · Fusion Biopsy · Clinically Significant Prostate Cancer
Bottom Line
View on ClinicalTrials.gov: NCT03044197 ↗Enrolled (actual)
24
Serious AEs
0.0%
Results posted
May 2019
Primary outcome: Primary: Number of Participants With Clinically Significant Prostate Cancer — 6; 6 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- MRI/ultrasound transperineal prostate biopsy (Device); transrectal ultrasound-guided prostate biopsy (Device)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- Male
- Sponsor
- The University of Texas Medical Branch, Galveston
- Primary completion
- Apr 2018
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants With Clinically Significant Prostate Cancer |
6; 6 | — |
| SECONDARY Overall Detection Rate of Prostate Cancer Between Arm A mpMRI+ and Arm B |
8; 7 | — |
| SECONDARY Comparison of UTI Incidence in Arm A mpMRI+ and Arm B |
0; 0 | — |
Summary
Prostate biopsies are currently the gold standard for the diagnosis of prostate cancer. Many biopsies, however, are unnecessary or cannot detect significant prostate cancer (PCa). With multi-parametric magnetic resonance imaging (mpMRI) we now potentially have a way of increasing the detection of detecting clinically significant prostate cancer (csPCa) while decreasing the detection of non-significant PCa.
Eligibility Criteria
Inclusion Criteria
- Males aged 18-75 years old
- PSA >1 ng/ml but <15 ng/ml
- Negative DRE
- Signed informed consent
Exclusion Criteria
- Previous prostate biopsy or prostate surgery
- Previous prostate mpMRI
- Contraindication to mpMRI: patients with pacemakers, defibrillators or other implanted electronic devices
- Patients in the Texas Department of Criminal Justice (prisoners)
- Patients with acute urinary symptoms including urinary retention and urinary tract infection
Data sourced from ClinicalTrials.gov (NCT03044197). 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.