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

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.

Study Overview

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

Detailed Description

The efficacy of targeting lesions for ultrasound-guided biopsy, surgery,or ablation may be limited by the visibility of a target during the procedure. The successful outcome of the intervention depends upon accurate device placement.

Historically, prostate cancer was diagnosed by finger guided trans-rectal prostate biopsies. However, with the advent of PSA screening and improvements in ultrasonography, ultrasound guided prostate biopsy has become the standard of care to screen and diagnose men with prostate cancer. A standard 12-14 core prostate biopsy is now common practice, detecting cancer in 27% to 44% of patients in patients with an elevated serum PSA.

Initially, prostate MR imaging was not considered for routine clinical practice. However, the addition of an endorectal-coil probe and a 3 Tesla magnet has improved its diagnostic utility. Currently, most mpMRI are done without the use of an endo-rectal coil at 3Tesla. The MRI is able to evaluate the entire prostate (transrectal ultrasound images are overlaid on a previously obtained prostate MRI, combined with an electromagnetic tracking system) prior to biopsy and allows the physician to target specific areas of the prostate that are suspicious for cancer. This contrasts with the typical US guided approach which samples regions of the prostate in a standard fashion.

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. The researchers are interested in learning which procedure is more useful in obtaining a diagnosis of prostate cancer which will in turn provide a better diagnosis rate. Each patient will act as their own control.

• Study Type: Interventional
• Enrollment (Estimated): 1586
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Cynthia Knauer, RN; Phone Number: 646-874-4733; Email: cknauer1@northwell.edu
• Study Contact Backup: Name: Ardeshir R Rastinehad, DO; Phone Number: 212-434-6580; Email: Arastine@northwell.edu

Study Locations

• United States
  • New York
    • Lake Success, New York, United States, 11042
      • Recruiting
      • The Smith Institute for Urology
      • Contact: Cynthia Knauer, RN; Phone Number: 646-874-4733; Email: cknauer1@northwell.edu
      • Contact: Peter Tricarico; Email: ptricarico1@northwell.edu
    • New York, New York, United States, 10022
      • Recruiting
      • The Smith Institute for Urology at Lenox Hill
      • Contact: Ardeshir Rastinehad, DO; Phone Number: 212-434-6580; Email: Arastine@northwell.edu
    • New York, New York, United States, 10065
      • Recruiting
      • Manhattan Eye, Ear, and Throat Hospital (MEETH)
      • Contact: Ardeshir Rastinehad, DO; Phone Number: 212-434-6580; Email: Arastine@northwell.edu

Participation Criteria

Eligibility Criteria

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

Description

Inclusion Criteria:

1. All patients must have a pre-operative MRI performed in accordance with Northwell/NIH MR Prostate imaging guidelines or equivalent.
2. Age greater than 18 years.
3. No serious concurrent medical illness that would preclude the patient from making a rational informed decision on participation.
4. The ability to understand willingness to sign a written informed consent form, and to comply with the protocol. If in question, an ethics consult will be obtained.
5. Ability to tolerate sedation and or general anesthesia if required.
6. PSA >1.8 or Abnormal digital rectal exam or current recommendations or biopsy from the American Urological Association.
7. Pre-Biopsy prostate MRI as described above, showing targetable lesions within 4 months of biopsy
8. Able to tolerate an ultrasound guided biopsy.

Exclusion Criteria:

1. Patients with an altered mental status that precludes understanding or consenting for the biopsy procedure will be excluded from this study
2. Patients unlikely able to hold reasonably still on a procedure table for the length of the procedure
3. 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 ultrasound guided prostate biopsy and a MR/TRUS Fusion Guided 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.; Other: Prostate Biopsy; Standard of care; Other Names: Transperineal (TP) Prostate Biopsy; UroNav Fusion Biopsy; Targeted prostate biopsy; Ultrasound guided Prostate Biopsy; 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.; Other Names: Fusion Biopsy

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	1 Month

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: Ardeshir Rastinehad
• Collaborators: Philips Healthcare
• Investigators: Principal Investigator: Ardeshir Rastinehad, DO, Northwell Health

Study record dates

Study Major Dates

• Study Start (Actual): August 21, 2020
• Primary Completion (Estimated): October 15, 2025
• Study Completion (Estimated): January 15, 2026

Study Registration Dates

• First Submitted: October 16, 2020
• First Submitted That Met QC Criteria: October 21, 2020
• First Posted (Actual): October 22, 2020

Study Record Updates

• Last Update Posted (Actual): February 2, 2024
• Last Update Submitted That Met QC Criteria: February 1, 2024
• Last Verified: February 1, 2024

More Information

Terms related to this study

• Keywords: Prostate Cancer; Prostate Biopsy; Fusion Biopsy; Targeted Prostate Biopsy; Prostate MRI
• Additional Relevant MeSH Terms: Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Genital Neoplasms, Male; Urogenital Diseases; Male Urogenital Diseases; Genital Diseases, Male; Genital Diseases; Prostatic Neoplasms; Prostatic Diseases
• Other Study ID Numbers: 20-0384

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