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

NCT04599218 | Recruiting DMC FDA Device

• 1 other identifier: 20-0384
• Study Type: interventional
• Target: 1,586
• Locations: 1 country
• Sites: 3

Brief 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

Keywords

Prostate Cancer; Prostate Biopsy; Prostate MRI; Targeted Prostate Biopsy; Fusion Biopsy

Outcome Measures

Primary Outcomes (1)

• Incidence of Prostate Cancer

  Incidence of diagnosing subjects with prostate cancer with MR visible lesions

  1 Month

Secondary Outcomes (3)

• Incidence of adverse events

  1 Month

• Pirads score

  1 Month

• Gleason score

  1 Month

Study Arms (1)

Males with Prostate Cancer

EXPERIMENTAL

Each participant will receive standard of care ultrasound guided prostate biopsy and a MR/TRUS Fusion Guided prostate biopsy.

Other: Prostate Biopsy; Other: MR US Fusion Guided Prostate Biopsy; Device: MR/TRUS Fusion Guided Prostate Biopsy

Interventions

Prostate Biopsy OTHER

Standard of care

Also known as: Transperineal (TP) Prostate Biopsy, UroNav Fusion Biopsy, Targeted prostate biopsy, Ultrasound guided Prostate Biopsy

Males with Prostate Cancer

MR US Fusion Guided Prostate Biopsy OTHER

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.

Also known as: Fusion Biopsy

Males with Prostate Cancer

MR/TRUS Fusion Guided Prostate Biopsy DEVICE

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.

Males with Prostate Cancer

Eligibility Criteria

• Age: 18 Years+
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• All patients must have a pre-operative MRI performed in accordance with Northwell/NIH MR Prostate imaging guidelines or equivalent.
• 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 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 \>1.8 or Abnormal digital rectal exam or current recommendations or biopsy from the American Urological Association.
• Pre-Biopsy prostate MRI as described above, showing targetable lesions within 4 months of biopsy
• Able to tolerate an ultrasound guided biopsy.

You may not qualify if:

• 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 uncorrectable coagulopathies.

Sponsors & Collaborators

• Ardeshir Rastinehad: lead
• Philips Healthcare: collaborator

Study Sites (3)

The Smith Institute for Urology

Lake Success, New York, 11042, United States

RECRUITING

The Smith Institute for Urology at Lenox Hill

New York, New York, 10022, United States

RECRUITING

Manhattan Eye, Ear, and Throat Hospital (MEETH)

New York, New York, 10065, United States

RECRUITING

MeSH Terms

Conditions

Prostatic Diseases; Prostatic Neoplasms

Condition Hierarchy (Ancestors)

Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Male Urogenital Diseases; Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms

Study Officials

• Ardeshir Rastinehad, DO

  Northwell Health

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Ardeshir R Rastinehad, DO

CONTACT

212-434-6580; Arastine@northwell.edu

Cynthia Knauer, RN

CONTACT

646-874-4733; cknauer1@northwell.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Associate Professor of Urology and Radiology, Vice Chair of Urology at Lenox Hill Hospital, System Director for Prostate Cancer

Study Record Dates

• First Submitted: October 16, 2020
• First Posted: October 22, 2020
• Study Start: August 21, 2020
• Primary Completion: October 15, 2025
• Study Completion: January 15, 2026
• Last Updated: February 2, 2024

Record last verified: 2024-02

Locations

US (3)