A Pilot Evaluation of the Efficacy of HistoScanning™ in Predicting the Presence and Location of Prostate Cancer in Men Undergoing Radical Prostatectomy
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- NYU Langone Health
- Enrollment
- 34
- Locations
- 1
- Primary Endpoint
- Correlation of Histoscan findings with Radical Prostatectomy Pathology
Study Overview
Brief Summary
This pilot clinical trial studies ultrasound imaging in finding prostate cancer in patients undergoing surgery. Diagnostic procedures, such as ultrasound imaging, may help find and diagnose prostate cancer. This study will serve as an analysis of the Histo-Scanning technology for the purpose of determining its ability to identify sites of prostate cancer at the time of prostate ultrasound.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Diagnostic
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- Male
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Patients who have completed a staging multiparametric MRI at New York University (NYU)
- •Patients who plan to undergo radical prostatectomy by open or robotic approach
Exclusion Criteria
- •Previous History of Prostate Cancer Radiation Treatment
- •Focal Ablation of the prostate for cancer treatment
- •Men receiving hormonal ablation within 6 months prior to undergoing radical prostatectomy
Arms & Interventions
Ultrasound Imaging
Men already electing to undergo radical prostatectomy will undergo transrectal ultrasound procedure at induction of anesthesia prior to their surgery procedure.
Intervention: Ultrasound Imaging (Procedure)
Outcomes
Primary Outcomes
Correlation of Histoscan findings with Radical Prostatectomy Pathology
Time Frame: up to 3 years
Compare location and concordance of findings on pre-op MRI \& Histoscan with radical prostatectomy specimen
Secondary Outcomes
- Extent of tumor and grade in treatment planning(Up to 3 years)