RECRUITING

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

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood 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.

Official Title

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

Quick Facts

Study Start:2020-08-21
Study Completion:2026-01-15
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT04599218

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.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:MALE
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. 1. All patients must have a pre-operative MRI performed in accordance with Northwell/NIH MR Prostate imaging guidelines or equivalent.
  2. 2. Age greater than 18 years.
  3. 3. No serious concurrent medical illness that would preclude the patient from making a rational informed decision on participation.
  4. 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. 5. Ability to tolerate sedation and or general anesthesia if required.
  6. 6. PSA \>1.8 or Abnormal digital rectal exam or current recommendations or biopsy from the American Urological Association.
  7. 7. Pre-Biopsy prostate MRI as described above, showing targetable lesions within 4 months of biopsy
  8. 8. Able to tolerate an ultrasound guided biopsy.
  1. 1. Patients with an altered mental status that precludes understanding or consenting for the biopsy procedure will be excluded from this study
  2. 2. Patients unlikely able to hold reasonably still on a procedure table for the length of the procedure
  3. 3. Patients with uncorrectable coagulopathies.

Contacts and Locations

Study Contact

Ardeshir R Rastinehad, DO
CONTACT
212-434-6580
Arastine@northwell.edu
Cynthia Knauer, RN
CONTACT
646-874-4733
cknauer1@northwell.edu

Principal Investigator

Ardeshir Rastinehad, DO
PRINCIPAL_INVESTIGATOR
Northwell Health

Study Locations (Sites)

The Smith Institute for Urology
Lake Success, New York, 11042
United States
The Smith Institute for Urology at Lenox Hill
New York, New York, 10022
United States
Manhattan Eye, Ear, and Throat Hospital (MEETH)
New York, New York, 10065
United States

Collaborators and Investigators

Sponsor: Ardeshir Rastinehad

  • Ardeshir Rastinehad, DO, PRINCIPAL_INVESTIGATOR, Northwell Health

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2020-08-21
Study Completion Date2026-01-15

Study Record Updates

Study Start Date2020-08-21
Study Completion Date2026-01-15

Terms related to this study

Keywords Provided by Researchers

  • Prostate Cancer
  • Prostate Biopsy
  • Prostate MRI
  • Targeted Prostate Biopsy
  • Fusion Biopsy

Additional Relevant MeSH Terms

  • Prostate Disease
  • Elevated Prostate Specific Antigen
  • Family History of Prostate Cancer
  • Positive Digital Rectal Exam
  • Prostate Cancer