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

Status: Recruiting
Location: See all (3) locations...
Intervention Type: Other, Device
Study Type: Interventional
Study Phase: Not Applicable
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.

Eligibility
Participation Requirements
Sex: Male
Minimum Age: 18
Healthy Volunteers: f
View:

• 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.

Locations
United States
New York
The Smith Institute for Urology
RECRUITING
Lake Success
Manhattan Eye, Ear, and Throat Hospital (MEETH)
RECRUITING
New York
The Smith Institute for Urology at Lenox Hill
RECRUITING
New York
Contact Information
Primary
Ardeshir R Rastinehad, DO
Arastine@northwell.edu
212-434-6580
Backup
Cynthia Knauer, RN
cknauer1@northwell.edu
646-874-4733
Time Frame
Start Date: 2020-08-21
Estimated Completion Date: 2026-01-15
Participants
Target number of participants: 1586
Treatments
Experimental: Males with Prostate Cancer
Each participant will receive standard of care ultrasound guided prostate biopsy and a MR/TRUS Fusion Guided prostate biopsy.
Sponsors
Collaborators: Philips Healthcare
Leads: Ardeshir Rastinehad

This content was sourced from clinicaltrials.gov

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