ProBot Device for Improved Prostate Biopsy
This study aims to evaluate the feasibility of the ProBot device by assessing pain, discomfort, adverse events, procedure time, complication rates, and success rates in men undergoing prostate biopsy.
Prostate biopsy
Urogenital Diseases+10
+ Genital Diseases
+ Disease
Device Feasibility Study
Summary
Study start date: September 23, 2025
Actual date on which the first participant was enrolled.Prostate cancer is the most diagnosed cancer among men in the United States and a leading cause of cancer-related deaths. This study focuses on improving the way prostate biopsies are done by using a new device called ProBot, which includes an advanced ultrasound probe and robot technology developed at Johns Hopkins. The goal is to make prostate cancer detection more accurate and less invasive, reducing unnecessary treatments. This study is important because it aims to enhance the precision of biopsies, which could lead to better diagnosis and management of prostate cancer. Participants in the study will undergo biopsies using the ProBot device, which is a small robot that allows for hands-free operation of the ultrasound probe. The device is designed to improve the accuracy of biopsies by ensuring the prostate gland is not deformed during imaging and needle targeting. The study measures the feasibility and safety of using this device by assessing factors such as procedural pain, patient discomfort, procedure time, and any complications. The results will help determine if the ProBot can successfully perform both transrectal and transperineal biopsies with minimal discomfort and high accuracy.
Protocol
This section provides details of the study plan, including how the study is designed and what the study is measuring.60 patients to be enrolled
Total number of participants that the clinical trial aims to recruit.Device Feasibility Study
Eligibility
Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.Male
Biological sex of participants that are eligible to enroll.From 40 to 75 Years
Range of ages for which participants are eligible to join.Healthy volunteers not allowed
If individuals who are healthy and do not have the condition being studied can participate.Conditions
Pathology
Criteria
Included in the study will be: * Men between the ages of 40 and 75 * Men must have one of the following "high risk" features: 1. PSA \> 4.0 ng/ml and/or abnormal digital rectal examination (DRE) 2. ASAP (atypical small acinar proliferation) on previous biopsy * Men with mpMRI or bpMRI exams, including both PI-RADS ≤2 and PI-RADS ≥3. Excluded from the study will be patients without available mpMRI exams and patients: * Females and children because of the prostate cancer targeted disease. * Patients who are not recommended or in whom TR or TP prostate biopsy is considered high-risk: 1. Patients with previous rectal surgery. 2. Patients with anal stenosis or coagulopathy. 3. Patients on active anticoagulation medication (eg. Coumadin, Lovenox, or Heparin). 4. Patients who cannot tolerate periprostatic Lidocaine block anesthesia or in whom anesthesia is considered high-risk. * Patients who already had a prostate biopsy taken with the ProBot investigational device. * Vulnerable populations, such as prisoners, institutionalized individuals. * Patients who are unwilling or unable to sign informed consent (no assent required).
Study Plan
Find out more about all the medication administered in this study, their detailed description and what they involve.2 intervention groups are designated in this study
This study does not include a placebo group
Treatment Groups
Group I
ExperimentalGroup II
ExperimentalStudy Objectives
Primary Objectives
Secondary Objectives
Study Centers
These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.This study has 1 location