MR/TRUS Fusion Guided Prostate Biopsy

MR/TRUS Fusion Guided Prostate Biopsy- An Improved Way To Detect And Quantify Prostate Cancer

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.

Study Overview

• Status: Unknown
• Conditions: Prostate Disease; Elevated Prostate Specific Antigen; Family History of Prostate Cancer; Positive Digital Rectal Exam
• Intervention / Treatment: Procedure: prostate biopsy; Procedure: MR US Fusion Guided Prostate Biopsy; Device: MR/TRUS Fusion Guided Prostate Biopsy

Detailed Description

The efficacy of targeting lesions for surgery may be limited by the visibility of a target during the procedure. The successful outcome of surgical intervention depends upon accurate device placement, which may be very challenging in certain settings, such as when a kidney tumor only is visible for a brief moment during the transient arterial phase of a contrast injection, and soon disappearing on dynamic imaging.

Historically, prostate cancer was diagnosed by digitally guided trans-rectal prostate biopsies. With PSA (Prostate Specific Antigen) screening and improvements in ultrasonography, trans-rectal ultrasound (TRUS) guided prostate biopsy have become the standard of care to screen and diagnose localized prostate cancer. Standard US 12-14 core prostate biopsy is now common practice, detecting cancer in 27% to 44% of patients.

Prostate MR imaging at 3 Tesla magnet dramatically improves diagnostic utility dramatically but biopsies are difficult, time-consuming, and require specialized equipment, which increases the cost significantly.

To meet this challenge 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.

This study will consist of comparison of the standard of care prostate biopsy with the protocol biopsy which consists of a US guided prostate biopsy and a MR/US fusion tracked prostate biopsy. Each patient will act as their own control.

• Study Type: Interventional
• Enrollment (Anticipated): 520
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Ardeshir Rastinehad, DO; Phone Number: 212-241-4812; Email: art.rastinehad@mountsinai.org
• Study Contact Backup: Name: Cynthia Knauer, RN, MS; Phone Number: 212-241-0751; Email: cynthia.knauer@mountsinai.org

Study Locations

• United States
  • New York
    • New York, New York, United States, 11101
      • Recruiting
      • Icahn School of Medicine at Mount Sinai
      • Principal Investigator: Ardeshir Rastinehad

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Male

Description

Inclusion Criteria:

• All patients must have a pre-operative MRI performed in accordance with the MT Sinai/NIH MR prostate imaging guidelines.
• Age greater than 18 years.
• No serious concurrent medical illness that would preclude the patient from making a rational informed decision on participation.
• The ability to understand and willingness to sign a written informed consent form, and to comply with the protocol. If in question, an ethics consult will be obtained.
• Ability to tolerate sedation and or general anesthesia if required.
• PSA >2.5 or Abnormal digital rectal exam or current recommendations for biopsy from the American Urological Association
• Pre-biopsy prostate MRI as described above, showing targetable lesions within 4 months of biopsy
• Able to tolerate a ultrasound guided biopsy

Exclusion Criteria:

• Patients with an altered mental status that precludes understanding or consenting for the biopsy procedure will be excluded from this study.
• Patients unlikely able to hold reasonably still on a procedure table for the length of the procedure.
• Patients with pacemakers or automatic implantable cardiac defibrillators (contraindications to MRI)
• Patients with uncorrectable coagulopathies.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: Males with Prostate Cancer; Each participant will receive standard of care prostate biopsy as well as a US guided prostate biopsy and a MR/TRUS Fusion Guided prostate biopsy guided prostate biopsy.

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; Other Names: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Incidence of Prostate Cancer	Incidence of diagnosing subjects with prostate cancer with MR visible lesions	Day 0 - day of procedure

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Incidence of adverse events	the incidence of adverse events occurring after a targeted and ultrasound guided prostate biopsy	1 month
Pirads score	The Prostate Imaging Reporting and Data System (PIRADS) score classifies MRI lesions on a scale from 1 to 5, which reflects their level of suspicion from least to most. Higher score indicates more suspicion.	1 month
Gleason score	The Gleason Score ranges from 1-5 and describes how much the cancer from a biopsy looks like healthy tissue (lower score) or abnormal tissue (higher score). Sum of the gleason grade of the most predominant tumor pattern and a second gleason grade of the second most predominant pattern. Full score from 2 to 10, with higher score indicating more clinically significance.	1 month

Collaborators and Investigators

• Sponsor: Icahn School of Medicine at Mount Sinai
• Collaborators: Philips Healthcare
• Investigators: Principal Investigator: Ardeshir Rastinehad, DO, Icahn School of Medicine at Mount Sinai

Publications and helpful links

General Publications

• Winoker JS, Wajswol E, Falagario U, Maritini A, Moshier E, Voutsinas N, Knauer CJ, Sfakianos JP, Lewis SC, Taouli BA, Rastinehad AR. Transperineal Versus Transrectal Targeted Biopsy With Use of Electromagnetically-tracked MR/US Fusion Guidance Platform for the Detection of Clinically Significant Prostate Cancer. Urology. 2020 Dec;146:278-286. doi: 10.1016/j.urology.2020.07.072. Epub 2020 Sep 18.

Study record dates

Study Major Dates

• Study Start (Actual): May 11, 2018
• Primary Completion (Anticipated): December 1, 2021
• Study Completion (Anticipated): December 1, 2021

Study Registration Dates

• First Submitted: July 17, 2019
• First Submitted That Met QC Criteria: July 18, 2019
• First Posted (Actual): July 19, 2019

Study Record Updates

• Last Update Posted (Actual): July 19, 2019
• Last Update Submitted That Met QC Criteria: July 18, 2019
• Last Verified: July 1, 2019

More Information

Terms related to this study

• Keywords: Targeted Prostate Biopsy
• Additional Relevant MeSH Terms: Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Genital Neoplasms, Male; Prostatic Neoplasms; Prostatic Diseases
• Other Study ID Numbers: GCO 15-0768

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: Yes