Prostate HistoScanning for the Non-invasive Detection and Staging of Prostate Cancer and Characterization of Prostate Tissues (PHS-02) (PHS-02)

October 26, 2012 updated by: Advanced Medical Diagnostics s.a.

Study design:

-The study will be a phase I like study to assess the extent to which prostate HistoScanning (PHS, the index test) can identify and characterize foci of prostate cancer when compared to histological samples harvested during radical prostatectomy (the reference test). The study will comprise 3 steps: first, defining the most suitable method for matching the TRUS (TransRectalUltrasonography) to histology (step 1); second, refining the algorithms (training set); third, verification of the PHS performances (test set).

Study objectives:

  • Primary Objective:

    • To evaluate the extent to which PHS can discriminate between malignant lesions of the prostate versus non-malignant tissue in 3D RF TRUS data using radical prostatectomy histological step sectioning as the reference test.

  • Secondary Objectives:

    • To adapt and refine PHS tissue characterisation algorithms using RF data that were previously developed using grey-level data as input.
    • To assess the accuracy of PHS in predicting the volume of prostate cancers determined by histology.
    • To assess the ability of PHS to rule in or rule out the presence of cancer > or = 0.5 cc and of > or = 0.2 cc as determined by histology.
    • To evaluate the ability to discriminate primary Gleason pattern 4 and 5 versus 3 or less in tumours > or = 0.5 cc and > or = 0.2 cc.
    • To assess the ability of PHS to correctly risk stratify patients.

Study Overview

Status

Completed

Conditions

Study Type

Observational

Enrollment (Actual)

52

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Belgium
      • Brussels, Belgium, 1000
        • Bordet Institute
      • Brussels, Belgium, 1090
        • UZ-Brussel
  • Czech Republic
      • Olomouc, Czech Republic, 775 20
        • Olomouc Hospital
  • Germany
      • Tübingen, Germany, 72076
        • Universitätsklinikum Tübingen
  • Hungary
      • Budapest, Hungary, H-1082
        • Semmelweis University
  • United Kingdom
      • London, United Kingdom, NW1 2BU
        • University College London Hospital (UCLH)
    • London
      • Hammersmith, London, United Kingdom, W6 8RF
        • Imperial College Healthcare NHS Trust, Charing Cross Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Male

Sampling Method

Non-Probability Sample

Study Population

Patients with histologically proven prostate cancer (positive biopsy) and who are planned to undergo radical prostatectomy.

Description

Inclusion Criteria:

  • Age: >or=18 year-old
  • Histologically (positive biopsy) proven prostate cancer with primary and secondary Gleason patterns attributed.
  • Patient planned to undergo radical prostatectomy
  • Prostate cancer is deemed to be organ confined (T1-T2, Nx or No, Mx or Mo)
  • No prior treatment for prostate cancer, including any type of hormonal therapy
  • No major calcification is noted during the TRUS (i.e. (Diameter >or=5 mm, spread all over the prostate or blocking to much of the ultrasound signal).
  • Patient willing to give written informed consent

Exclusion Criteria:

  • Patients who are either unsuitable or unwilling to enter the study or to proceed to surgical investigation.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
prostate cancer
Patients with histologically proven prostate cancer (positive biopsy) and who are planned to undergo radical prostatectomy.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Advanced Medical Diagnostics s.a.

Investigators

  • Study Director: Harry Bleiberg, MD

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2008

Study Completion (Actual)

June 1, 2012

Study Registration Dates

First Submitted

August 30, 2010

First Submitted That Met QC Criteria

August 30, 2010

First Posted (Estimate)

August 31, 2010

Study Record Updates

Last Update Posted (Estimate)

October 29, 2012

Last Update Submitted That Met QC Criteria

October 26, 2012

Last Verified

October 1, 2012

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CR2P00113

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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