Robotic assistance for prostate biopsy using ultrasound
Transrectal Ultrasound Robot-Assisted Prostate Biopsy
This study is testing whether a new robotic tool can help doctors take better samples during prostate biopsies to find cancer more accurately in men who need a biopsy.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 483 (estimated) |
| Ages | 45 Years to 75 Years |
| Sex | Male |
| Sponsor | Johns Hopkins University Academic / other |
| Locations | 1 site (Baltimore, Maryland) |
| Trial ID | NCT02871726 on ClinicalTrials.gov |
What this trial studies
This study aims to enhance the accuracy of prostate cancer detection by employing a novel robotic transrectal ultrasound (TRUS) manipulator during prostate biopsies. The research compares the effectiveness of this robotic-assisted biopsy technique against traditional methods in a randomized clinical trial. By utilizing advanced imaging techniques, the study seeks to improve the spatial distribution of biopsy samples and increase the detection rate of clinically significant prostate cancer. Participants will be men scheduled for an initial diagnostic biopsy due to elevated PSA levels or abnormal digital rectal exams.
Who should consider this trial
Good fit: Ideal candidates are men with elevated PSA levels or abnormal digital rectal exams who are scheduled for an initial diagnostic biopsy.
Not a fit: Patients with a prior diagnosis of prostate cancer or those who have undergone previous biopsies will not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could lead to more accurate prostate cancer diagnoses and better patient outcomes.
How similar studies have performed: Previous studies have shown promising results with robotic-assisted biopsy techniques, indicating potential for improved outcomes in prostate cancer detection.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Baltimore, Maryland
- Johns Hopkins Hospital — Baltimore, Maryland, United States (Recruiting)
Study contacts
- Principal investigator: Misop Han, M.D., M.S. — Johns Hopkins University
- Study coordinator: Misop Han, M.D., M.S.
- Email: mhan1@jhmi.edu
- Phone: 410-614-9442
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.