Ultrasound Imaging in Finding Prostate Cancer in Patients Undergoing Surgery

Prostate Cancer Clinical Trial

Official title:

A Pilot Evaluation of the Efficacy of HistoScanning™ in Predicting the Presence and Location of Prostate Cancer in Men Undergoing Radical Prostatectomy

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02024178
• Other study ID #: NYU11-00220
• Status: Completed
• Phase: N/A
• First received: December 26, 2013
• Last updated: June 16, 2016
• Start date: June 2011
• Est. completion date: May 2012

Study information

• Verified date: June 2016
• Source: New York University School of Medicine
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 34
• Est. completion date: May 2012
• Est. primary completion date: May 2012
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years and older

Eligibility

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

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Related Conditions & MeSH terms

• Prostate Cancer
• Prostatic Neoplasms

Intervention

Procedure:
• Ultrasound Imaging

Locations

Country	Name	City	State
United States	Smilow Comprehensive Prostate Cancer Center	New York	New York

Sponsors (1)

Lead Sponsor	Collaborator
New York University School of Medicine

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	Extent of tumor and grade in treatment planning	Describe correlation between tumor grade on final pathology and histoscan findings	Up to 3 years	No