Robot-Assisted MRI-Guided Prostate Biopsy
| Status: | Completed |
|---|---|
| Conditions: | Prostate Cancer, Cancer |
| Therapuetic Areas: | Oncology |
| Healthy: | No |
| Age Range: | 35 - 75 |
| Updated: | 1/16/2019 |
| Start Date: | July 25, 2013 |
| End Date: | January 2016 |
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.
(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.
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.
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.
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.
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