Robot-Assisted MRI-Guided Prostate Biopsy
Completed · Not applicable
Conditions studied: Prostate Cancer
In brief
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.
Key facts
- Study ID
- NCT02080052
- Run by
- Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
- People needed
- 5
- Starts
- 2013-07-25
- Expected to finish
- 2016-01-01
- Last updated by the study team
- 2019-01-14
Who can join
Age: 35 and older, up to 75. Sex: male. Healthy volunteers: not accepted.
You may qualify if…
- 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.
You may not qualify if…
- 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.
Where it is running
- The Johns Hopkins Hospital — Baltimore, Maryland, United States
Full record on ClinicalTrials.gov
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