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Procedure

Robot-Assisted Prostate Biopsy for Prostate Cancer

N/A

Recruiting

Led By Misop Han, M.D., M.S.

Research Sponsored by Johns Hopkins University

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Scheduled for an initial diagnostic biopsy

Elevated serum PSA (prostate specific antigen > 4 ng/ml) and/or abnormal digital rectal exam

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 5 years

Awards & highlights

Study Summary

This trial is testing a new device that is used in conjunction with TRUS to help guide a TB+SB procedure. The new device is called the Prostate Navigation System (PNS).

Who is the study for?

Men scheduled for their first diagnostic prostate biopsy with a high PSA level (>4 ng/ml) or an abnormal rectal exam can join. Those who've had a previous biopsy, already diagnosed with prostate cancer, unable to consent, have anal stenosis preventing probe insertion, or poor bowel prep cannot participate.Check my eligibility

What is being tested?

The trial is testing a robot-assisted method for taking prostate biopsies using ultrasound guidance (TRUS-Robot) against the standard freehand TRUS biopsy approach. It aims to improve accuracy and distribution of tissue samples taken from the prostate.See study design

What are the potential side effects?

Potential side effects may include discomfort or pain at the biopsy site, bleeding, infection risk increase due to the procedure, and possible complications related to robotic assistance such as extended procedure time.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

I am scheduled for my first biopsy to diagnose my condition.

Select...

My PSA levels are above 4 ng/ml or I had an abnormal prostate exam.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 5 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~5 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and 5 years for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Cancer Detection Rate of Clinically Insignificant Prostate Cancer

Cancer Detection Rate of Clinically Significant Prostate Cancer

Investigational device serious adverse events

Secondary outcome measures

Needle targeting accuracy

Predictive rates of detecting clinically significant prostate cancer at biopsy

Procedure time

+2 more

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: TRUS-Robot and TRUSExperimental Treatment2 Interventions

TRUS and TRUS-Robot will be used during prostate biopsy

Group II: Routine TRUS/Fusion biopsyActive Control1 Intervention

Just Uronav will be used during prostate biopsy

0 / 2Eligibility criteria met

Find a Location

Who is running the clinical trial?

National Institutes of Health (NIH)NIH

2,715 Previous Clinical Trials

7,509,915 Total Patients Enrolled

28 Trials studying Prostate Cancer

6,474 Patients Enrolled for Prostate Cancer

Johns Hopkins UniversityLead Sponsor

2,273 Previous Clinical Trials

14,839,909 Total Patients Enrolled

28 Trials studying Prostate Cancer

11,668 Patients Enrolled for Prostate Cancer

Misop Han, M.D., M.S.Principal InvestigatorJohns Hopkins University

4 Previous Clinical Trials

88 Total Patients Enrolled

2 Trials studying Prostate Cancer

56 Patients Enrolled for Prostate Cancer

Media Library

TRUS biopsy (Procedure) Clinical Trial Eligibility Overview. Trial Name: NCT02871726 — N/A

Prostate Cancer Research Study Groups: TRUS-Robot and TRUS, Routine TRUS/Fusion biopsy

Prostate Cancer Clinical Trial 2023: TRUS biopsy Highlights & Side Effects. Trial Name: NCT02871726 — N/A

TRUS biopsy (Procedure) 2023 Treatment Timeline for Medical Study. Trial Name: NCT02871726 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

How numerous are the participants in this investigation?

"Affirmative. According to records available on clinicaltrials.gov, this experiment is looking for participants and was initially published on November 24th 2021 with the most recent amendment made January 7th 2022. 483 volunteers are needed from one clinic location."

Answered by AI

Are there still opportunities for individuals to take part in this exploration?

"According to the clinicaltrials.gov registry, this medical study is still recruiting volunteers; it was initially made available on November 24th 2021 and recently revised on January 7th 2022."

Answered by AI

Is it possible for me to participate in this medical experiment?

"This medical trial welcomes 483 people with prostate cancer between the ages of 45 and 75. To qualify, applicants must have an upcoming biopsy appointment, a serum PSA (prostate specific antigen) level greater than 4 ng/ml, or an abnormal digital rectal exam result."

Answered by AI

Is the age criteria for this clinical trial restricted to those over sixty years of age?

"This clinical trial has a specific age range of 45-75. Those under the age threshold can look at 76 trials, whereas those above it may view 1315 studies."

Answered by AI

What are the aims of this research project?

"This research trial, slated to last for a duration of 5 years, will assess the Cancer Detection Rate of Clinically Insignificant [Prostate cancer](https://www.withpower.com/clinical-trials/prostate-cancer). Secondary aims involve comparing biopsy results with gold standard pathology in order to determine Sensitivity and Specificity when detecting clinically significant prostate cancer at biopsy as well as Procedure Time."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Transrectal Ultrasound Robot-Assisted Prostate Biopsy

2021. "Transrectal Ultrasound Robot-Assisted Prostate Biopsy". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT02871726.

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