RECRUITING

Transrectal Ultrasound Robot-Assisted Prostate Biopsy

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

Prostate cancer (PCa) is the most common non-dermatologic malignancy in U.S. men. Transrectal ultrasound (TRUS)-guided prostate biopsy is a commonly used diagnostic procedure for men with an elevated serum prostate-specific antigen (PSA) level and/or abnormal digital rectal examination (DRE). It is estimated that more than 1 million TRUS-guided prostate biopsies are performed annually in the U.S. alone. However, a freehand TRUS-guided systematic biopsy (SB) procedure has significant limitations. First, freehand biopsy cores are often spatially clustered, rather than uniformly distributed, and do not accurately follow the recommended, sextant template. Second, a freehand TRUS-guided biopsy does not allow precise mapping of the biopsy cores within the prostate. Targeted biopsy (TB) using special devices emerged to help the physicians guide the biopsy using multiparametric MRI (mpMRI). TB cores yield a higher cancer detection rate of clinically significance PCa than SB cores, but TB cores also miss a large number of clinically significant PCa that are detected by SB. Accordingly, TB is commonly performed concurrently with SB (TB+SB procedure).

Official Title

Transrectal Ultrasound Robot-Assisted Prostate Biopsy

Quick Facts

Study Start:2021-11-24
Study Completion:2026-08
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT02871726

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:45 Years to 75 Years
Sexes Eligible for Study:MALE
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Scheduled for an initial diagnostic biopsy
  2. * Elevated serum PSA (prostate specific antigen\> 4 ng/ml) and/or abnormal digital rectal exam
  1. * Clinical diagnosis of prostate cancer
  2. * Prior prostate biopsy
  3. * Anal stenosis that prevents TRUS probe insertion
  4. * Inadequate bowel prep
  5. * Unwilling or unable to sign the informed consent

Contacts and Locations

Study Contact

Misop Han, M.D., M.S.
CONTACT
410-614-9442
mhan1@jhmi.edu
Dan Stoianovici, PhD
CONTACT
410-550-1980
dss@jhu.edu

Principal Investigator

Misop Han, M.D., M.S.
PRINCIPAL_INVESTIGATOR
Johns Hopkins University

Study Locations (Sites)

Johns Hopkins Hospital
Baltimore, Maryland, 21287
United States

Collaborators and Investigators

Sponsor: Johns Hopkins University

  • Misop Han, M.D., M.S., PRINCIPAL_INVESTIGATOR, Johns Hopkins University

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 Date2021-11-24
Study Completion Date2026-08

Study Record Updates

Study Start Date2021-11-24
Study Completion Date2026-08

Terms related to this study

Keywords Provided by Researchers

  • Prostate Cancer Detection
  • Prostate Biopsy
  • Prostate Cancer
  • Transrectal Ultrasound

Additional Relevant MeSH Terms

  • Prostate Cancer