NCT03077126

Brief Summary

The main purpose of this study is to determine the accuracy and feasibility (possibility) of Aixplorer® ShearWave Elastography (SWE™) Ultrasound System (made by SuperSonic Imagine, Inc.) for detecting prostate cancer in men undergoing radical prostatectomy.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
10

participants targeted

Target at below P25 for not_applicable prostate-cancer

Timeline
Completed

Started Apr 2013

Geographic Reach
1 country

1 active site

Status
completed

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

April 11, 2013

Completed
2.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 29, 2015

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 18, 2015

Completed
1.5 years until next milestone

First Submitted

Initial submission to the registry

March 2, 2017

Completed
8 days until next milestone

First Posted

Study publicly available on registry

March 10, 2017

Completed
Last Updated

March 13, 2017

Status Verified

March 1, 2017

Enrollment Period

2.2 years

First QC Date

March 2, 2017

Last Update Submit

March 9, 2017

Conditions

Prostate Cancer

Keywords

elastographyultrasoundprostatecancer screening

Outcome Measures

Primary Outcomes (1)

  • Rate of Correlation Between Ultrasound Results and Pathology Results

    Investigators will correlate the pathology findings from the radical prostatectomy specimen with the data recorded from USE.

    6 months

Study Arms (1)

Pre-surgery Ultrasound

OTHER

Aixplorer® ShearWave Elastography (SWE™) Ultrasound. Participants will undergo ultrasound prep with Fleet Enema and ultrasound procedure at their pre-op visit one to two weeks before their standard of care prostatectomy.

Other: Fleet EnemaDevice: Aixplorer® ShearWave Elastography (SWE™)Diagnostic Test: Pre-surgery UltrasoundProcedure: Prostatectomy

Interventions

Fleet EnemaOTHER

Since a probe will be introduced into the participant's rectal area, participants will be instructed to give themself one regular Fleet enema.

Also known as: enema
Pre-surgery Ultrasound
Aixplorer® ShearWave Elastography (SWE™)DEVICE

Pre-surgery ultrasound: Aixplorer® ShearWave Elastography (SWE™) Ultrasound System (made by SuperSonic Imagine, Inc.). The device is used transrectally. This device (ultrasound system) has been cleared by the United States Food and Drug Administration (FDA) for the indication for use as described in this consent form.

Also known as: ultrasound device, probe
Pre-surgery Ultrasound
Pre-surgery UltrasoundDIAGNOSTIC_TEST

The ultrasound procedure referenced above will be performed at the participant's pre-op visit one to two weeks before their surgery.

Also known as: Aixplorer® ShearWave Elastography (SWE™), ultrasound elastography
Pre-surgery Ultrasound
ProstatectomyPROCEDURE

Participants will undergo radical prostatectomy as currently performed at our Moffitt Cancer Center. This procedure is performed under general anesthesia in the operating room. This is considered standard of care.

Also known as: prostate surgery
Pre-surgery Ultrasound

Eligibility Criteria

Age18 Years+
Sexmale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Men with prostate cancer who elect surgery as the primary treatment of their cancer and to be performed at the Moffitt Cancer Center.
  • Biopsy confirmed prostate cancer with at least ten biopsies performed for diagnosis.
  • Location of cancer specified in the pathology report.
  • Pathology reviewed by Moffitt pathologist

You may not qualify if:

  • Less than ten biopsies obtained at time of diagnosis.
  • Location of cancer not specified.
  • Pathology not reviewed by Moffitt pathologist.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

H. Lee Moffitt Cancer Center and Research Institute

Tampa, Florida, 33612, United States

Location

Related Links

MeSH Terms

Conditions

Prostatic Neoplasms

Interventions

sodium phosphateEnemaUltrasonographyProstatectomy

Condition Hierarchy (Ancestors)

Genital Neoplasms, MaleUrogenital NeoplasmsNeoplasms by SiteNeoplasmsGenital Diseases, MaleGenital DiseasesUrogenital DiseasesProstatic DiseasesMale Urogenital Diseases

Intervention Hierarchy (Ancestors)

Drug TherapyTherapeuticsDiagnostic ImagingDiagnostic Techniques and ProceduresDiagnosisUrologic Surgical Procedures, MaleUrologic Surgical ProceduresUrogenital Surgical ProceduresSurgical Procedures, Operative

Study Officials

  • Julio Pow-Sang, M.D.

    H. Lee Moffitt Cancer Center and Research Institute

    PRINCIPAL INVESTIGATOR

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

March 2, 2017

First Posted

March 10, 2017

Study Start

April 11, 2013

Primary Completion

June 29, 2015

Study Completion

September 18, 2015

Last Updated

March 13, 2017

Record last verified: 2017-03

Locations

US(1)