MedTrace Logo

MR/TRUS Fusion Guided Prostate Biopsy

NCT04026763 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 520

Last updated 2019-07-19

No results posted yet for this study

Summary

This study will determine if targeted (Magnetic Resonance (MR) / Ultrasound (US) fusion biopsy) plus conventional biopsy is superior to conventional biopsy alone in diagnosing subjects with prostate cancer.

Conditions

  • Prostate Disease
  • Elevated Prostate Specific Antigen
  • Family History of Prostate Cancer
  • Positive Digital Rectal Exam

Interventions

PROCEDURE

prostate biopsy

standard of care

PROCEDURE

MR US Fusion Guided Prostate Biopsy

Trans-rectal ultrasound (TRUS) guided fusion prostate biopsy, Transperineal Ultrasound guided fusion prostate biopsy

DEVICE

MR/TRUS Fusion Guided Prostate Biopsy

TRUS images are overlaid on a previously obtained prostate MRI, combined with an electromagnetic tracking system. The urologist then performs directed prostate biopsies at MR-identified targets in addition to the standard prostate biopsies.

Sponsors & Collaborators

Principal Investigators

  • Ardeshir Rastinehad, DO · Icahn School of Medicine at Mount Sinai

Study Design

Allocation
NA
Purpose
DIAGNOSTIC
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
MALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-05-11
Primary Completion
2021-12-31
Completion
2021-12-31
FDA Device
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Companies

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 NCT04026763 on ClinicalTrials.gov