Transrectal Ultrasound Robot-Assisted Prostate Biopsy

Prostate Cancer Clinical Trial

Official title:

Transrectal Ultrasound Robot-Assisted Prostate Biopsy

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02871726
• Other study ID #: IRB00068488
• Status: Recruiting
• Phase: N/A
• Start date: November 24, 2021
• Est. completion date: August 2026

Study information

• Verified date: February 2024
• Source: Johns Hopkins University
• Contact: Misop Han, M.D., M.S.
• Phone: 410-614-9442
• Email: mhan1[@]jhmi.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 483
• Est. completion date: August 2026
• Est. primary completion date: August 2026
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 45 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Prostate Cancer
• Prostatic Neoplasms

Intervention

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.

Locations

Country	Name	City	State
United States	Johns Hopkins Hospital	Baltimore	Maryland

Sponsors (2)

Lead Sponsor	Collaborator
Johns Hopkins University	National Institutes of Health (NIH)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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	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
Secondary	Procedure time	The time of the actual biopsy procedure measured in minutes.	Up to 30 minutes
Secondary	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
Secondary	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
Secondary	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