Back to resultsUltrasound Imaging in Finding Prostate Cancer in Patients Undergoing Surgery
Primary Purpose
Prostate Cancer
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Ultrasound Imaging
Sponsored by
About this trial
This is an interventional diagnostic trial for Prostate Cancer focused on measuring Prostate Cancer, Radical Prostatectomy, Ultrasound Imaging
Eligibility Criteria
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
Sites / Locations
- Smilow Comprehensive Prostate Cancer Center
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Ultrasound Imaging
Arm Description
Men already electing to undergo radical prostatectomy will undergo transrectal ultrasound procedure at induction of anesthesia prior to their surgery procedure.
Outcomes
Primary Outcome Measures
Correlation of Histoscan findings with Radical Prostatectomy Pathology
Compare location and concordance of findings on pre-op MRI & Histoscan with radical prostatectomy specimen
Secondary Outcome Measures
Extent of tumor and grade in treatment planning
Describe correlation between tumor grade on final pathology and histoscan findings
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02024178
Brief Title
Ultrasound Imaging in Finding Prostate Cancer in Patients Undergoing Surgery
Official Title
A Pilot Evaluation of the Efficacy of HistoScanning™ in Predicting the Presence and Location of Prostate Cancer in Men Undergoing Radical Prostatectomy
Study Type
Interventional
2. Study Status
Record Verification Date
June 2016
Overall Recruitment Status
Completed
Study Start Date
June 2011 (undefined)
Primary Completion Date
May 2012 (Actual)
Study Completion Date
May 2012 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
NYU Langone Health
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Prostate Cancer
Keywords
Prostate Cancer, Radical Prostatectomy, Ultrasound Imaging
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
34 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Ultrasound Imaging
Arm Type
Experimental
Arm Description
Men already electing to undergo radical prostatectomy will undergo transrectal ultrasound procedure at induction of anesthesia prior to their surgery procedure.
Intervention Type
Procedure
Intervention Name(s)
Ultrasound Imaging
Primary Outcome Measure Information:
Title
Correlation of Histoscan findings with Radical Prostatectomy Pathology
Description
Compare location and concordance of findings on pre-op MRI & Histoscan with radical prostatectomy specimen
Time Frame
up to 3 years
Secondary Outcome Measure Information:
Title
Extent of tumor and grade in treatment planning
Description
Describe correlation between tumor grade on final pathology and histoscan findings
Time Frame
Up to 3 years
10. Eligibility
Sex
Male
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Samir Taneja, MD
Organizational Affiliation
NYU Langone Health
Official's Role
Principal Investigator
Facility Information:
Facility Name
Smilow Comprehensive Prostate Cancer Center
City
New York
State/Province
New York
ZIP/Postal Code
10016
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Ultrasound Imaging in Finding Prostate Cancer in Patients Undergoing Surgery
We'll reach out to this number within 24 hrs