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

Description

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

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Study Overview

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Study Details

Study overview

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.

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

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

Condition
Prostate Disease
Intervention / Treatment

-

Contacts and Locations

Lake Success

The Smith Institute for Urology, Lake Success, New York, United States, 11042

New York

The Smith Institute for Urology at Lenox Hill, New York, New York, United States, 10022

New York

Manhattan Eye, Ear, and Throat Hospital (MEETH), New York, New York, United States, 10065

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility 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.
  • 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.

Ages Eligible for Study

18 Years to

Sexes Eligible for Study

MALE

Accepts Healthy Volunteers

No

Collaborators and Investigators

Ardeshir Rastinehad,

Ardeshir Rastinehad, DO, PRINCIPAL_INVESTIGATOR, Northwell Health

Study Record Dates

2026-01-15