NCT01639859

Brief Summary

The primary aim of the study is to assess the elasticity (Young's modulus) of cancerous tumor foci, of normal peripheral zone, and of normal transition zone in the prostate. Images obtained with the Supersonic Imagine Aixplorer scanner prior to radical prostatectomy are compared to whole-mount histology.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Oct 2011

Typical duration for not_applicable

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

October 1, 2011

Completed
9 months until next milestone

First Submitted

Initial submission to the registry

June 22, 2012

Completed
21 days until next milestone

First Posted

Study publicly available on registry

July 13, 2012

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2012

Completed
10 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2013

Completed
Last Updated

January 10, 2025

Status Verified

January 1, 2025

Enrollment Period

1 year

First QC Date

June 22, 2012

Last Update Submit

January 9, 2025

Conditions

Cancer of Prostate

Keywords

prostate cancerelastographyelasticity

Outcome Measures

Primary Outcomes (3)

  • Young's modulus(kPa) of cancerous tumor foci

    2 years

  • Young's modulus(kPa) of normal peripheral zone

    2 years

  • Young's modulus(kPa) of normal transition zone

    2 years

Study Arms (1)

Elastography

EXPERIMENTAL
Other: Elastography

Interventions

ElastographyOTHER

The elastography in vivo will be performed before the prostatectomy. The elastography ex vivo will be performed after radical prostatectomy.

Also known as: Supersonic Imagine Aixplorer scanner
Elastography

Eligibility Criteria

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

You may qualify if:

  • Patient over 18 years old, with prostate cancer and scheduled for radical prostatectomy

You may not qualify if:

  • Medical history of prostate surgery or radiotherapy of prostate
  • Medical history of abdominal perinéanal amputation or whole of state which prevent to use endorectal probe

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Service de Radiologie, Pavillon P Radio, Hôpital Edouard Herriot

Lyon, LYON, 69 437, France

Location

Related Publications (1)

  • Rouviere O, Melodelima C, Hoang Dinh A, Bratan F, Pagnoux G, Sanzalone T, Crouzet S, Colombel M, Mege-Lechevallier F, Souchon R. Stiffness of benign and malignant prostate tissue measured by shear-wave elastography: a preliminary study. Eur Radiol. 2017 May;27(5):1858-1866. doi: 10.1007/s00330-016-4534-9. Epub 2016 Aug 23.

    PMID: 27553936BACKGROUND

MeSH Terms

Conditions

Prostatic Neoplasms

Condition Hierarchy (Ancestors)

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

Study Officials

  • ROUVIERE Olivier, Pr

    Hospices Civils de Lyon

    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

June 22, 2012

First Posted

July 13, 2012

Study Start

October 1, 2011

Primary Completion

October 1, 2012

Study Completion

August 1, 2013

Last Updated

January 10, 2025

Record last verified: 2025-01

Locations

FR(1)