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MR/TRUS Fusion Guided Prostate Biopsy - An Improved Way to Detect and Quantify Prostate Cancer

NCT04599218 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 1586

Last updated 2024-02-02

No results posted yet for this study

Summary

This research study is designed to determine if targeted Magnetic Resonance Imaging (MRI) Ultrasound (US) fusion biopsy is better than the standard of care ultrasound guided biopsy alone in diagnosing subjects with clinically significant prostate cancer with MRI visible lesions. This study will consist of comparing the standard of care (ultrasound guided prostate biopsy) with the protocol biopsy which consists of an ultrasound guided prostate biopsy and a MRI/US fusion tracked prostate biopsy.

Conditions

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

Interventions

OTHER

Prostate Biopsy

Standard of care

OTHER

MR US Fusion Guided Prostate Biopsy

Trans-rectal ultrasound (TRUS) guided fusion prostate biopsy (Arm 1) or a Transperineal Ultrasound guided fusion prostate biopsy (Arm 2). All patients will under go a standard ultrasound guided biopsy at the time of their targeted (fusion) 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

  • Philips Healthcare

    collaborator INDUSTRY

  • Ardeshir Rastinehad

    lead OTHER

Principal Investigators

  • Ardeshir Rastinehad, DO · Northwell Health

Study Design

Allocation
NA
Purpose
DIAGNOSTIC
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
MALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-08-21
Primary Completion
2025-10-15
Completion
2026-01-15
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 NCT04599218 on ClinicalTrials.gov