Transrectal Ultrasound Robot-Assisted Prostate Biopsy

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).

Study Overview

• Status: Recruiting
• Conditions: Prostate Cancer
• Intervention / Treatment: Device: TRUS-Robot; Other: TRUS biopsy

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.

• Study Type: Interventional
• Enrollment (Estimated): 483
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Misop Han, M.D., M.S.; Phone Number: 410-614-9442; Email: mhan1@jhmi.edu
• Study Contact Backup: Name: Dan Stoianovici, PhD; Phone Number: 410-550-1980; Email: dss@jhu.edu

Study Locations

• United States
  • Maryland
    • Baltimore, Maryland, United States, 21287
      • Recruiting
      • Johns Hopkins Hospital
      • Contact: Misop Han, M.D.; Phone Number: 410-614-9442

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 45 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: TRUS-Robot and TRUS; TRUS and TRUS-Robot will be used during prostate biopsy	Device: TRUS-Robot; A robotic device used to hold and manipulate the ultrasound probe during a transrectal prostate biopsy.; Other: TRUS biopsy; Uronav for prostate biopsy.
Active Comparator: Routine TRUS/Fusion biopsy; Just Uronav will be used during prostate biopsy	Other: TRUS biopsy; Uronav for prostate biopsy.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Cancer Detection Rate of Clinically Significant Prostate Cancer	Number of biopsy patients diagnosed with Gleason score >= 7 over the total number of patients on both arms of the study.	5 years
Investigational device serious adverse events	Serious adverse events will be assessed according to 21 Code of Federal Regulations (CFR) Part 812.3(s).	5 years
Cancer Detection Rate of Clinically Insignificant Prostate Cancer	Number of biopsy patients diagnosed with Gleason score <= 6 over the total number of patients on both arms of the study.	5 years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Needle targeting accuracy	Needle targeting errors will be measured as the distance between the planned core center and the inserted needle axis. Targeting accuracy will be calculated as the average of the needle targeting errors, as usual.	5 years
Procedure time	The time of the actual biopsy procedure measured in minutes.	Up to 30 minutes
Sensitivity of detecting clinically significant prostate cancer at biopsy	Compare biopsy pathology results with gold standard pathology on the subset of patients who follow on to radical prostatectomy. Perform binary tests (True/False x Positive/Negative) and calculate sensitivity.	5 years
Specificity of detecting clinically significant prostate cancer at biopsy	Compare biopsy pathology results with gold standard pathology on the subset of patients who follow on to radical prostatectomy. Perform binary tests (True/False x Positive/Negative) and calculate specificity.	5 years
Predictive rates of detecting clinically significant prostate cancer at biopsy	Compare biopsy pathology results with gold standard pathology on the subset of patients who follow on to radical prostatectomy. Perform binary tests (True/False x Positive/Negative) and calculate predictive rates.	5 years

Collaborators and Investigators

• Sponsor: Johns Hopkins University
• Collaborators: National Institutes of Health (NIH)
• Investigators: Principal Investigator: Misop Han, M.D., M.S., Johns Hopkins University

Study record dates

Study Major Dates

• Study Start (Actual): November 24, 2021
• Primary Completion (Estimated): August 1, 2026
• Study Completion (Estimated): August 1, 2026

Study Registration Dates

• First Submitted: August 10, 2016
• First Submitted That Met QC Criteria: August 15, 2016
• First Posted (Estimated): August 18, 2016

Study Record Updates

• Last Update Posted (Estimated): February 13, 2024
• Last Update Submitted That Met QC Criteria: February 9, 2024
• Last Verified: February 1, 2024

More Information

Terms related to this study

• Keywords: Prostate Cancer; Prostate Cancer Detection; Prostate Biopsy; Transrectal Ultrasound
• Additional Relevant MeSH Terms: Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Genital Neoplasms, Male; Prostatic Diseases; Urogenital Diseases; Male Urogenital Diseases; Genital Diseases, Male; Genital Diseases; Prostatic Neoplasms
• Other Study ID Numbers: IRB00068488

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No