Prostate Cancer Clinical Trial
Official title:
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).
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 |
Country | Name | City | State |
---|---|---|---|
United States | Johns Hopkins Hospital | Baltimore | Maryland |
Lead Sponsor | Collaborator |
---|---|
Johns Hopkins University | National Institutes of Health (NIH) |
United States,
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 |
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