Ultrasound Imaging in Finding Prostate Cancer in Patients Undergoing Surgery
A Pilot Evaluation of the Efficacy of HistoScanning™ in Predicting the Presence and Location of Prostate Cancer in Men Undergoing Radical Prostatectomy
1 other identifier
interventional
34
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable prostate-cancer
Started Jun 2011
Shorter than P25 for not_applicable prostate-cancer
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
June 1, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2012
CompletedStudy Completion
Last participant's last visit for all outcomes
May 1, 2012
CompletedFirst Submitted
Initial submission to the registry
December 26, 2013
CompletedFirst Posted
Study publicly available on registry
December 31, 2013
CompletedJune 17, 2016
June 1, 2016
11 months
December 26, 2013
June 16, 2016
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Correlation of Histoscan findings with Radical Prostatectomy Pathology
Compare location and concordance of findings on pre-op MRI \& Histoscan with radical prostatectomy specimen
up to 3 years
Secondary Outcomes (1)
Extent of tumor and grade in treatment planning
Up to 3 years
Study Arms (1)
Ultrasound Imaging
EXPERIMENTALMen already electing to undergo radical prostatectomy will undergo transrectal ultrasound procedure at induction of anesthesia prior to their surgery procedure.
Interventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Smilow Comprehensive Prostate Cancer Center
New York, New York, 10016, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Samir Taneja, MD
NYU Langone Health
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- DIAGNOSTIC
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
December 26, 2013
First Posted
December 31, 2013
Study Start
June 1, 2011
Primary Completion
May 1, 2012
Study Completion
May 1, 2012
Last Updated
June 17, 2016
Record last verified: 2016-06