NCT00824902

Brief Summary

The primary objective is to perform a pilot trial evaluation of a novel prostate ultrasound imaging software utilizing tissue elasticity measurements to identify tumor foci among men who will undergo radical prostatectomy for localized prostate cancer. As a secondary objective, investigators will compare elasticity measured tumor foci volume to the measured volume from radical prostatectomy pathologic examination.

Trial Health

57
Monitor

Trial Health Score

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

Enrollment
13

participants targeted

Target at below P25 for not_applicable prostate-cancer

Timeline
Completed

Started Dec 2008

Typical duration for not_applicable prostate-cancer

Geographic Reach
1 country

1 active site

Status
terminated

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

December 1, 2008

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

January 15, 2009

Completed
4 days until next milestone

First Posted

Study publicly available on registry

January 19, 2009

Completed
4.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2013

Completed
Last Updated

January 9, 2015

Status Verified

December 1, 2013

Enrollment Period

4.9 years

First QC Date

January 15, 2009

Last Update Submit

January 7, 2015

Conditions

Prostate Cancer

Keywords

Prostate CancerProstateRadical ProstatectomyTissue ElastographyTissue Elastography ImagingSoftware Program Measuring Prostate ElasticityElasticity/Tissue Strain-Hardening ImagingUltrasound

Outcome Measures

Primary Outcomes (1)

  • Evaluation of diagnostic technique (using tissue elastography) for prostate cancer detection in men scheduled to undergo a radical prostatectomy

    Pilot evaluation of novel prostate ultrasound imaging software utilizing tissue elasticity measurements to identify tumor foci among men who will undergo radical prostatectomy for localized prostate cancer. The methods of Bland and Altman (1986) used to assess whether the tumor volume estimated by the ultrasound imaging technique agrees with the tumor volume measured at pathology. An ultrasound based elasticity measurement technique will detect differences in prostate hardness by using sophisticated mathematical techniques to analyze ultrasound images obtained before and after small compressions of the prostate gland with the ultrasound probe, detecting differences in hardness by measuring relative displacements of portions of the gland. Elasticity images obtained during standard, medically-indicated prostate sonography.

    2 Years

Study Arms (1)

Tissue Elastography Imaging

EXPERIMENTAL

Using special elastography software, probe pressed gently against prostate during routine ultrasound before prostate surgery, 10-15 minutes process.

Procedure: Tissue Elastography Imaging

Interventions

Tissue Elastography ImagingPROCEDURE

Using special elastography software, probe pressed gently against prostate during routine ultrasound before prostate surgery, 10-15 minutes process.

Tissue Elastography Imaging

Eligibility Criteria

Sexmale
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Patients selected for radical prostatectomy (any technique) at MDACC
  • Histologic diagnosis of prostate cancer, clinical stage cT1c-cT3b
  • Serum prostate specific antigen less than 30 ng/ml.
  • Any Gleason score
  • Total prostate volume of 20-60 cc, measured by outside ultrasound or clinical examination at MDACC.
  • Group 1: high volume disease. At least 3 positive cores containing cancer on one side of the prostate Group 2: low volume disease. Less than 50% tumor length in a single positive core on one side of the prostate

You may not qualify if:

  • Prior radiation therapy to the pelvis
  • Prior hormonal therapy within 3 months (including LH/RH agonists, estrogens, testosterone receptor blockade, finasteride, dutasteride)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

UT MD Anderson Cancer Center

Houston, Texas, 77030, United States

Location

Related Links

MeSH Terms

Conditions

Prostatic Neoplasms

Condition Hierarchy (Ancestors)

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

Study Officials

  • John W. Davis, MD

    UT MD Anderson Cancer Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 15, 2009

First Posted

January 19, 2009

Study Start

December 1, 2008

Primary Completion

November 1, 2013

Study Completion

November 1, 2013

Last Updated

January 9, 2015

Record last verified: 2013-12

Locations

US(1)