Robot-Assisted MRI-Guided Prostate Biopsy

Prostate Cancer Clinical Trial

Official title:

Robot-Assisted MRI-Guided Prostate Biopsy

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02080052
• Other study ID #: J1163
• Secondary ID: 1RC1EB010936-01N
• Status: Completed
• Phase: N/A
• Start date: July 25, 2013
• Est. completion date: January 2016

Study information

• Verified date: January 2019
• Source: Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Prostate biopsies are commonly performed freehanded under transrectal ultrasound guidance (TRUS). Due to the manual approach and the limitations of the ultrasound imager, the procedure has high false-negative rates. This represents a daily problem for urologists managing the disease, creates uncertainty and emotional stress for patients, and initiates a cascade of repeat testing and biopsies which also burden the investigators healthcare system.

The investigators believe that prostate biopsy can be improved by using a new biopsy paradigm. The investigators plan to perform MRI-guided prostate biopsies with robot-assistance for orienting a needle-guide through which the biopsy is taken. The combination of MRI and robotic precision is expected to improve prostate biopsy sensitivity compared to regular TRUS biopsies.

The study is a Pilot clinical trial on 5 patients to primarily assess feasibility and safety. The needle-guide robot is an investigational device developed in their Urology Robotics Laboratory.

Description:

While prostate cancer is the most common non-dermatologic malignancy among men in the US, it is frequently indolent and may not require radical therapy, i.e. radical prostatectomy or external beam radiotherapy. There has been increased interest in conservative approaches to low risk disease, including both active surveillance and focal therapy. Both of these approaches require accurate mapping of the prostate to allow for reproducible access to diseased portions of the gland, for biopsy or treatment purposes. Magnetic resonance imaging (MRI) has been increasingly utilized for prostate cancer staging and is considered the most accurate technique available for imaging prostate cancer. Furthermore there is increasing concern about the use of freehand transrectal ultrasound (TRUS) and needle biopsying in terms of reproducibility and accuracy in mapping disease. With systematic TRUS-guided biopsy the sensitivity of the test is low (33%-44%) and yields high false-negative rates (23%) [1, 2].

The investigators hypothesize that the integration of a novel robotic device for assisting MRI-guided prostate biopsy is feasible, safe, and accurate. This represents the first clinical trial of robotic assistance for MRI-guided transperineal prostate biopsy. The device consists of a robotic needle-guide instrument developed in the investigators Urology Robotics Laboratory. The robot orients a needle-guide on target based on MRI. The physician verifies the alignment and manually takes the biopsy, as usual. Pre-clinical tests showed that the robot operates precisely and safely in the MRI scanner and does not deteriorate imaging quality.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 5
• Est. completion date: January 2016
• Est. primary completion date: January 2016
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 35 Years to 75 Years

Eligibility

Inclusion Criteria:

• men between the ages of 35 and 75,

• have a negative 12 core prostate biopsy, and

• must have one of the following "high risk" features:

• PSA >= 5.0 ng/ml and Prostate Volume <= 50cc,

• PSA density >= 0.2ng/ml/cc,

• Percent Free PSA <=10%,

• PSA velocity > 0.5 ng/ml/year,

• High Grade Prostate Intraepithelial Neoplasia on previous biopsy, or Atypia on previous biopsy.

Exclusion Criteria:

• bleeding problems,

• metal implants precluding MRI scanning,

• previous rectal surgery, anal stenosis that precludes endorectal coil insertion,

• patients who cannot tolerate anesthesia or in whom anesthesia is considered high-risk, and

• patients who are unwilling or unable to sign informed consent.

Related Conditions & MeSH terms

• Prostate Cancer

Intervention

Device:
• Robot-assisted prostate biopsy

Locations

Country	Name	City	State
United States	The Johns Hopkins Hospital	Baltimore	Maryland

Sponsors (2)

Lead Sponsor	Collaborator
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins	National Institute for Biomedical Imaging and Bioengineering (NIBIB)

Country where clinical trial is conducted

United States, 

References & Publications (10)

Badaan S, Petrisor D, Kim C, Mozer P, Mazilu D, Gruionu L, Patriciu A, Cleary K, Stoianovici D. Does needle rotation improve lesion targeting? Int J Med Robot. 2011 Jun;7(2):138-47. doi: 10.1002/rcs.381. Epub 2011 Mar 1. — View Citation

Ball MW, Ross AE, Ghabili K, Kim C, Jun C, Petrisor D, Pan L, Epstein JI, Macura KJ, Stoianovici DS, Allaf ME. Safety and Feasibility of Direct Magnetic Resonance Imaging-guided Transperineal Prostate Biopsy Using a Novel Magnetic Resonance Imaging-safe R — View Citation

Bonekamp D, Jacobs MA, El-Khouli R, Stoianovici D, Macura KJ. Advancements in MR imaging of the prostate: from diagnosis to interventions. Radiographics. 2011 May-Jun;31(3):677-703. doi: 10.1148/rg.313105139. Review. — View Citation

Cunha JA, Hsu IC, Pouliot J, Roach Iii M, Shinohara K, Kurhanewicz J, Reed G, Stoianovici D. Toward adaptive stereotactic robotic brachytherapy for prostate cancer: demonstration of an adaptive workflow incorporating inverse planning and an MR stealth robot. Minim Invasive Ther Allied Technol. 2010 Aug;19(4):189-202. doi: 10.3109/13645706.2010.497000. — View Citation

Kim C, Chang D, Petrisor D, Chirikjian G, Han M, Stoianovici D. Ultrasound probe and needle-guide calibration for robotic ultrasound scanning and needle targeting. IEEE Trans Biomed Eng. 2013 Jun;60(6):1728-34. doi: 10.1109/TBME.2013.2241430. Epub 2013 Jan 21. — View Citation

Muntener M, Patriciu A, Petrisor D, Mazilu D, Bagga H, Kavoussi L, Cleary K, Stoianovici D. Magnetic resonance imaging compatible robotic system for fully automated brachytherapy seed placement. Urology. 2006 Dec;68(6):1313-7. — View Citation

Srimathveeravalli G, Kim C, Petrisor D, Ezell P, Coleman J, Hricak H, Solomon SB, Stoianovici D. MRI-safe robot for targeted transrectal prostate biopsy: animal experiments. BJU Int. 2014 Jun;113(6):977-85. doi: 10.1111/bju.12335. Epub 2013 Dec 2. — View Citation

Stoianovici D, Patriciu A, Petrisor D, Mazilu D, Kavoussi L. A New Type of Motor: Pneumatic Step Motor. IEEE ASME Trans Mechatron. 2007 Feb 1;12(1):98-106. — View Citation

Stoianovici D, Song D, Petrisor D, Ursu D, Mazilu D, Muntener M, Schar M, Patriciu A. "MRI Stealth" robot for prostate interventions. Minim Invasive Ther Allied Technol. 2007;16(4):241-8. Erratum in: Minim Invasive Ther Allied Technol. 2007;16(6):370. Mutener, Michael [corrected to Muntener, Michael]. — View Citation

Stoianovici D. Technology advances for prostate biopsy and needle therapies. J Urol. 2012 Oct;188(4):1074-5. doi: 10.1016/j.juro.2012.06.127. Epub 2012 Aug 15. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of participants with adverse events		Three months
Primary	Logged unsuccessful attempts to target prostate		1 year
Primary	Time for device setup, image registration, MRI time, biopsy sampling		1 year
Primary	Score for operation of the device	Score assigned by the engineers on a 1 to 5 scale	1 year
Primary	Score for image deterioration	Score assigned by radiologist on image quality on a 1 to 5 scale	1 year
Primary	Quality of the obtained biopsy specimen	Score assigned by the pathologist on a 1-5 scale.	1 year
Primary	Overall grade of the device and procedure	Grade give by urologist, radiologist and anesthesiologist on a 1-5 scale.	1 year
Secondary	Distance from the collected to planned biopsy core center measured on DICOM		One year
Secondary	Number of needle trajectory corrections needed for alignment of each biopsy core		1 year
Secondary	Number of diagnosed prostate cancers		1 year
Secondary	Number of positive/total cores for each patient		1 year
Secondary	Correlation of pathology findings with cancer specific region (CSR)s on MRI		1 year