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Detection of Clinically Significant Prostate Cancer Using Transperineal Targeted Biopsy Compared to Standard Transrectal Biopsy

NCT03044197 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 24

Last updated 2019-06-05

Study results available
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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.

Conditions

  • Prostate Cancer
  • Magnetic Resonance Imaging
  • Target Lesion
  • Fusion Biopsy
  • Clinically Significant Prostate Cancer
  • Transperineal

Interventions

DEVICE

MRI/ultrasound transperineal prostate biopsy

3-6 targeted biopsy cores from each prostate region of interest

DEVICE

transrectal ultrasound-guided prostate biopsy

12 systematic biopsy cores

Sponsors & Collaborators

  • The University of Texas Medical Branch, Galveston

    lead OTHER

Principal Investigators

  • Stephen B Williams, MD · University of Texas

Study Design

Allocation
RANDOMIZED
Purpose
DIAGNOSTIC
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
MALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2017-07-25
Primary Completion
2018-04-12
Completion
2018-04-12
FDA Device
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03044197 on ClinicalTrials.gov