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Prostate CancerNCT02080052

Robot-Assisted MRI-Guided Prostate Biopsy

A study testing Robot-assisted prostate biopsy in people with Prostate Cancer, run by Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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. Read more about this study

Who is it for?
Ages 35 to 75 years, men only
Conditions the study is for
Prostate Cancer
What is being tested?
Robot-assisted prostate biopsy
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
5 participants
Where
1 siteUnited States
Study dates
25 Jul 2013to Jan 2016
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 35 to 75 years
  • Men only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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.

Trial locations and contacts

1 site in 1 country.

United States1 site

  • The Johns Hopkins Hospital

    Baltimore, Maryland, 21287

Other trials in United States

About this study

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.

Read the 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
Being tested
Robot-assisted prostate biopsy
Medical subject headings
Prostatic Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Robot-assisted prostate biopsyDevice

Study groups in NCT02080052
Study groupRoleWhat they receive
Robot-assisted prostate biopsyExperimentalNot described
Receives: Device: Robot-assisted prostate biopsy

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Number of participants with adverse events

    Measured: Three months

  2. Logged unsuccessful attempts to target prostate

    Measured: 1 year

  3. Time for device setup, image registration, MRI time, biopsy sampling

    Measured: 1 year

  4. Score for operation of the device

    Score assigned by the engineers on a 1 to 5 scale

    Measured: 1 year

  5. Score for image deterioration

    Score assigned by radiologist on image quality on a 1 to 5 scale

    Measured: 1 year

  6. Quality of the obtained biopsy specimen

    Score assigned by the pathologist on a 1-5 scale.

    Measured: 1 year

  7. Overall grade of the device and procedure

    Grade give by urologist, radiologist and anesthesiologist on a 1-5 scale.

    Measured: 1 year

Secondary outcomes (5)

  1. Distance from the collected to planned biopsy core center measured on DICOM

    Measured: One year

  2. Number of needle trajectory corrections needed for alignment of each biopsy core

    Measured: 1 year

  3. Number of diagnosed prostate cancers

    Measured: 1 year

  4. Number of positive/total cores for each patient

    Measured: 1 year

  5. Correlation of pathology findings with cancer specific region (CSR)s on MRI

    Measured: 1 year

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted6 Mar 2014 (estimated)
  2. Study start25 Jul 2013
  3. Primary completionJan 2016
  4. Study completionJan 2016

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Device feasibility
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
5 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02080052
Sponsor's protocol ID
J1163
Other IDs
1RC1EB010936-01, NA_00025078
Status last verified
Jan 2019
First submitted
6 Feb 2014
Last updated
14 Jan 2019
Results posted
No
Data monitoring committee
Yes

Publications

  • 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.

    PubMed 24118992

  • 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.

    PubMed 23358940

  • 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.

    PubMed 22901579

  • 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.

    PubMed 21571651

  • 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.

    PubMed 21360796

  • 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.

    PubMed 20642386

  • 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.

    PubMed 17763098

  • 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.

    PubMed 21528106

  • 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.

    PubMed 17169653

  • 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.

    PubMed 28735018

Questions about this trial

What is this clinical trial studying?

A study testing Robot-assisted prostate biopsy in people with Prostate Cancer, run by Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 8 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 14 Jan 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Number of participants with adverse events (time frame: Three months). The study lists 7 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02080052, which also lists 10 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Jan 2019.

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