Recruiting

Transrectal Ultrasound

Sponsor:

Johns Hopkins University

Code:

NCT02871726

Conditions

Prostate Cancer

Eligibility Criteria

Sex: Male

Age: 45 - 70+

Healthy Volunteers: Not accepted

Interventions

TRUS-Robot

TRUS biopsy

Study Details

Brief summary:

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).

Conditions

Prostate Cancer

Study ID

NCT02871726

Start date

Nov 24, 2021

Status verified date

Aug, 2026

Completion date

Aug, 2029

Anticipated

Primary completion date

Aug, 2029

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Male

Age: 45 - 70+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • Scheduled for an initial diagnostic biopsy
  • Elevated serum PSA (prostate specific antigen> 4 ng/ml) and/or abnormal digital rectal exam

Exclusion Criteria:

  • Clinical diagnosis of prostate cancer
  • Prior prostate biopsy
  • Anal stenosis that prevents TRUS probe insertion
  • Inadequate bowel prep
  • Unwilling or unable to sign the informed consent

Study Design

Enrollment

483 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Diagnostic

Interventions and Outcome Measures

Arms

experimental: TRUS-Robot and TRUS

TRUS and TRUS-Robot will be used during prostate biopsy

active comparator: Routine TRUS/Fusion biopsy

Just Uronav will be used during prostate biopsy

Interventions

TRUS-Robot

A robotic device used to hold and manipulate the ultrasound probe during a transrectal prostate biopsy.

TRUS biopsy

Uronav for prostate biopsy.

Primary outcome measure

  • Cancer Detection Rate of Clinically Significant Prostate Cancer [ Time Frame: 5 years ]
  • Investigational device serious adverse events [ Time Frame: 5 years ]
  • Cancer Detection Rate of Clinically Insignificant Prostate Cancer [ Time Frame: 5 years ]

Central Contacts and Locations

Central contacts

Misop Han, M.D., M.S.

410-614-9442mhan1@jhmi.edu

Dan Stoianovici, PhD

410-550-1980dss@jhu.edu

Locations

Johns Hopkins Hospital

Recruiting

Baltimore, Maryland, United States, 21287

Contacts

Misop Han, M.D.

410-614-9442

More Information

Sponsor

Johns Hopkins University

Last update posted

Aug 26, 2026

Last verified

Aug, 2026

Keywords

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

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Johns Hopkins University on 2026-08-26.