Ultrasound Imaging in Finding Prostate Cancer in Patients... | NCT02024178

Studies
Ultrasound Imaging in Finding Prostate Cancer in Patients Undergoing Surgery

NCT02024178

Sponsor

NYU Langone Health

Status

Completed

Last Update Posted

Jun 17, 2016Estimated

Enrollment

34Actual

Phase

Not Applicable

Conditions

Prostate Cancer

Interventions

Ultrasound Imaging

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jun 2016

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jun 2011

Primary Completion Date

May 2012Actual

Completion Date

May 2012Actual

First Submitted Date

Dec 26, 2013

First Submission Date that Met QC Criteria

Dec 26, 2013

First Posted Date

Dec 31, 2013Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jun 16, 2016

Last Update Posted Date

Jun 17, 2016Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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 provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

34Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Ultrasound Imaging	Experimental	Men already electing to undergo radical prostatectomy will undergo transrectal ultrasound procedure at induction of anesthesia prior to their surgery procedure.	Procedure: Ultrasound Imaging

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Ultrasound Imaging	Procedure		Ultrasound Imaging

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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

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

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Sex

Male

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Samir Taneja, MD	NYU Langone Health	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Smilow Comprehensive Prostate Cancer Center		New York	New York	10016	United States

Condition Browse Module

MeSH Terms

ID	Term
D011471	Prostatic Neoplasms

Ancestor Terms

ID	Term
D005834	Genital Neoplasms, Male
D014565	Urogenital Neoplasms
D009371	Neoplasms by Site
D009369	Neoplasms

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D019220	High-Energy Shock Waves

Ancestor Terms

ID	Term
D000069453	Ultrasonic Waves
D013016	Sound
D011840	Radiation, Nonionizing
D011827	Radiation

Browse Leaves

Not provided

Browse Branches

Not provided