Robot-Assisted Biopsy for Prostate Cancer

Overseen By Sara A Naizghi

Age: 18+

Sex: Male

Trial Phase: Phase 1

Sponsor: Johns Hopkins University

Must not be taking: Anticoagulants

Disqualifiers: Females, Children, Rectal surgery, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 2

Duration: 1 day

60 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new robot-assisted method for prostate cancer biopsies. The ProBot device uses a special ultrasound probe to help doctors take more accurate tissue samples, potentially improving diagnosis and treatment. The trial aims to determine the device's safety and effectiveness in two different biopsy methods. Men at high risk for prostate cancer or with certain test results, such as a PSA level higher than 4.0 or an abnormal prostate exam, might be suitable candidates for this trial. As a Phase 1 trial, the research focuses on understanding how the treatment works in people, offering participants the opportunity to be among the first to receive this innovative approach.

Do I need to stop my current medications for the trial?

The trial does not specify if you need to stop taking your current medications, but you cannot participate if you are on active anticoagulation medication (blood thinners like Coumadin, Lovenox, or Heparin).

What prior data suggests that the ProBot device is safe for prostate biopsies?

Research has shown that robot-assisted prostate biopsies, such as those using the ProBot device, are generally safe and well-tolerated. For the transperineal method, studies have found complications to be rare, with only about 1.1% of patients experiencing issues. The most common problem, difficulty urinating, occurred in just 0.9% of cases and was often linked to a larger prostate size.

For the transrectal method, research has also confirmed its safety and effectiveness. This approach allows precise targeting of the biopsy needle, which can enhance cancer detection while maintaining safety. These findings suggest that although the ProBot system is new, it reduces risks and improves accuracy compared to traditional methods. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about robot-assisted prostate biopsy because it combines advanced imaging with robotic precision, which could improve accuracy in detecting prostate cancer. Unlike traditional manual biopsies, this method uses a novel ultrasound probe fused with MRI to guide the needle, potentially leading to more precise sampling. The trial compares two approaches: the transperineal and transrectal pathways, both utilizing this cutting-edge technology. This could reduce the risk of missing cancerous tissue and improve diagnosis, making it a promising advancement over standard biopsy techniques.

What evidence suggests that the ProBot device is effective for prostate cancer biopsy?

Research has shown that using robots to assist with prostate biopsies holds promise for detecting prostate cancer. Participants in this trial will undergo either the transperineal or transrectal approach. In the transperineal approach, studies found cancer in 61% of cases, with 35% being serious. Another study found cancer in 51.2% of cases, with 40.1% being serious. The transrectal approach also appears promising. Tests demonstrated that robot-assisted biopsies are more accurate and precise than traditional methods. This suggests that robots could enhance prostate cancer detection. ^{1 2 6 7 8}

Who Is on the Research Team?

Misop Han, MD

Principal Investigator

Johns Hopkins University

Are You a Good Fit for This Trial?

This trial is for men with prostate cancer or thalassemia who may benefit from a more accurate biopsy. Participants should be suitable candidates for MRI-targeted and systematic biopsies, either transrectally or transperineally. Specific eligibility details are not provided but typically would exclude those with contraindications to the procedure.

Inclusion Criteria

I am a man aged between 40 and 75.

My MRI results show areas of concern in my prostate.

I am a man with a PSA over 4.0, an abnormal DRE, or ASAP found in a biopsy.

Exclusion Criteria

I cannot have a standard prostate biopsy due to health risks or conditions.

Patients without available mpMRI exams

I have had a prostate biopsy with the ProBot device.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants undergo robot-assisted prostate biopsy using the ProBot device, with procedures including transperineal and transrectal biopsies guided by ultrasound fused with MRI.

1 day

1 visit (in-person)

Follow-up

Participants are monitored for safety, device feasibility, and adverse events, including assessments of discomfort, pain, and prostate cancer detection rates.

4 weeks

1-2 visits (in-person or virtual)

What Are the Treatments Tested in This Trial?

Interventions

• Robot-Assisted Prostate Biopsy with Novel Ultrasound Probe

Trial Overview The study tests a new robot-assisted ultrasound probe called ProBot designed for precise prostate biopsies. It aims to improve accuracy by preventing gland deformation during 3D scanning and needle targeting, potentially enhancing MRI-ultrasound fusion results.

How Is the Trial Designed?

Group I: Transrectal biopsy (TR) Experimental Treatment 1 Intervention

Biopsy guided by transrectal ultrasound fused with MRI and needle inserted on a transrectal path

Group II: Transperineal biopsy (TP) Experimental Treatment 1 Intervention

Biopsy guided by transrectal ultrasound fused with MRI and needle inserted on a transperineal path.

Who Is Running the Clinical Trial?

Johns Hopkins University

Lead Sponsor

Trials

2,366

Recruited

15,160,000+

National Cancer Institute (NCI)

Collaborator

Trials

14,080

Recruited

41,180,000+

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT07271017

Robot-Assisted Prostate Biopsy With a Novel Ultrasound ... Prostate cancer detection rates at systematic biopsy (SB), Clinically significant PCa detection rates at SB throughout the study, Up to one ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11075013/

Evaluating the Effectiveness and Safety of Robotic ... The study conducted on a sample of 19 patients revealed an overall cancer detection rate of 73.7%, with a csPca detection rate of 15.8%. Lee et al demonstrated ...

3. nature.com nature.com/articles/s41598-024-55492-w

The learning curve for robotic-assisted transperineal MRI ... Overall, PCa was detected in 61% and csPCa in 35% of biopsies. PCa and csPCa detection rates per operator on patient level stratified by PI-RADS ...

4. sciencedirect.com sciencedirect.com/science/article/pii/S2287888223000600

Shifting to transperineal prostate biopsy: A narrative review A study by Miah et al showed a detection rate of 51.2% for overall prostate cancer and a detection rate of 40.1% for clinically significant prostate cancer.

5. urotoday.com urotoday.com/index.php?option=com_acymailing&ctrl=archive&task=view&mailid=14152&key=F7Mi8oII&subid=-&tmpl=component&Itemid=1448&utm_source=newsletter_14152&utm_medium=email&utm_campaign=innovation-at-the-intersection-of-engineering-and-urology-highlights-from-the-38th-annual-eus-meeting-at-the-aua&acm=_14152

Highlights from the 38th Annual EUS Meeting at the AUA Andreas Forsvall presented a novel prostate biopsy needle that achieved a 96% reduction in bacterial transfer and significantly improved targeting accuracy ...

6. nature.com nature.com/articles/s41598-025-23101-z

Accuracy and safety of in-office transperineal freehand ... Complications were rare (1.1%), with urinary retention being the most common (0.9%), associated with larger prostate volume (> 50 mL). Combining ...

7. sciencedirect.com sciencedirect.com/science/article/pii/S2472630324000669

Feasibility and safety study of advanced prostate biopsy ... The study utilized an advanced prostate biopsy robot system based on MR-TRUS image flexible registration technology and conducted experiments on animal models.

8. mdpi.com mdpi.com/2218-6581/14/8/100

PRONOBIS: A Robotic System for Automated Ultrasound ... This paper presents the PRONOBIS project, an ultrasound-only, robotically assisted, deep learning-based system for prostate scanning and biopsy treatment ...