Ultrasound Imaging in Finding Prostate Cancer in Patients Undergoing Surgery

Not Applicable

Completed

• Conditions: Prostate Cancer
• Interventions: Procedure: Ultrasound Imaging

• Registration Number: NCT02024178
• Lead Sponsor: NYU Langone Health

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2011-06
• Primary Completion: 2012-05
• Study Completion: 2012-05
• Study First Submitted: 2013-12-26
• Study First Submitted QC: 2013-12-26
• Study First Posted: 2013-12-31
• Status Verified: 2016-06
• Last Update Submitted: 2016-06-16
• Last Update Posted: 2016-06-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 34

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Ultrasound Imaging	Ultrasound Imaging	Men already electing to undergo radical prostatectomy will undergo transrectal ultrasound procedure at induction of anesthesia prior to their surgery procedure.

Primary Outcome Measures

Name	Time	Method
Correlation of Histoscan findings with Radical Prostatectomy Pathology	up to 3 years	Compare location and concordance of findings on pre-op MRI \& Histoscan with radical prostatectomy specimen

Secondary Outcome Measures

Name	Time	Method
Extent of tumor and grade in treatment planning	Up to 3 years	Describe correlation between tumor grade on final pathology and histoscan findings

Trial Locations

Locations (1)

Smilow Comprehensive Prostate Cancer Center; 🇺🇸 New York, New York, United States