Transrectal Ultrasound Robot-Assisted Prostate Biopsy

NCT ID: NCT02871726

Last Updated: 2025-02-10

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 483 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-11-24
• Study Completion Date: 2026-08-31

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).

Detailed Description

This study attempts to improve TRUS-guided prostate biopsy by utilizing assistance from a novel robotic TRUS manipulator (TRUS-Robot) developed by our team. The hypothesis of the study is that clinically significant prostate cancer detection rate from the SB cores (at SB or TB+SB) can be improved above that of current devices. The objective of the study is to gain early evidence on the effectiveness of prostate biopsy assisted by the TRUS-Robot vs. a current TB device in a randomized clinical trial.

Conditions

Prostate Cancer

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Study Groups

TRUS-Robot and TRUS

TRUS and TRUS-Robot will be used during prostate biopsy

Group Type: EXPERIMENTAL

TRUS-Robot

Intervention Type: DEVICE

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

TRUS biopsy

Intervention Type: OTHER

Uronav for prostate biopsy.

Routine TRUS/Fusion biopsy

Just Uronav will be used during prostate biopsy

Group Type: ACTIVE_COMPARATOR

TRUS biopsy

Intervention Type: OTHER

Uronav for prostate biopsy.

Interventions

TRUS-Robot

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

Intervention Type: DEVICE

TRUS biopsy

Uronav for prostate biopsy.

Intervention Type: OTHER

Eligibility Criteria

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

• Minimum Eligible Age: 45 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: No

Sponsors

National Institutes of Health (NIH)

NIH

Sponsor Role: collaborator

Johns Hopkins University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

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

Role: PRINCIPAL_INVESTIGATOR

Johns Hopkins University

Locations

Johns Hopkins Hospital

Baltimore, Maryland, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

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

Role: CONTACT

mhan1@jhmi.edu

410-614-9442

Dan Stoianovici, PhD

Role: CONTACT

dss@jhu.edu

410-550-1980

Facility Contacts

Misop Han, M.D.

Role: primary

410-614-9442

Other Identifiers

IRB00068488

Identifier Type: -

Identifier Source: org_study_id