Robot-Assisted MRI-Guided Prostate Biopsy

NCT ID: NCT02080052

Last Updated: 2019-01-14

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 5 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-07-25
• Study Completion Date: 2016-01-31

Brief 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.

Detailed 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.

Conditions

Prostate Cancer

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: DEVICE_FEASIBILITY
• Blinding Strategy: NONE

Study Groups

Robot-assisted prostate biopsy

Group Type: EXPERIMENTAL

Robot-assisted prostate biopsy

Intervention Type: DEVICE

Interventions

Robot-assisted prostate biopsy

Intervention Type: DEVICE

Eligibility Criteria

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.

• Minimum Eligible Age: 35 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: No

Sponsors

National Institute for Biomedical Imaging and Bioengineering (NIBIB)

NIH

Sponsor Role: collaborator

Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Mohamad E Allaf, MD

Role: PRINCIPAL_INVESTIGATOR

Johns Hopkins University

Mark W Ball, MD

Role: STUDY_DIRECTOR

Johns Hopkins University

Locations

The Johns Hopkins Hospital

Baltimore, Maryland, United States

Countries

United States

References

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.

Reference Type: BACKGROUND

PMID: 24118992 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 23358940 (View on PubMed)

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. No abstract available.

Reference Type: BACKGROUND

PMID: 22901579 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 21571651 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 21360796 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 20642386 (View on PubMed)

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. doi: 10.1080/13645700701520735.

Reference Type: BACKGROUND

PMID: 17763098 (View on PubMed)

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. doi: 10.1109/TMECH.2006.886258.

Reference Type: BACKGROUND

PMID: 21528106 (View on PubMed)

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. doi: 10.1016/j.urology.2006.08.1089.

Reference Type: BACKGROUND

PMID: 17169653 (View on PubMed)

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 Robotic Device. Urology. 2017 Nov;109:216-221. doi: 10.1016/j.urology.2017.07.010. Epub 2017 Jul 19.

Reference Type: RESULT

PMID: 28735018 (View on PubMed)

Other Identifiers

1RC1EB010936-01

Identifier Type: NIH

Identifier Source: secondary_id

View Link

NA_00025078

Identifier Type: OTHER

Identifier Source: secondary_id

J1163

Identifier Type: -

Identifier Source: org_study_id