Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Advanced Medical Diagnostics s.a.
ClinicalTrials.gov Identifier:
NCT01191931
First received: August 30, 2010
Last updated: October 26, 2012
Last verified: October 2012
  Purpose

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.

Condition
Prostate Cancer

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Prostate HistoScanning for the Non-invasive Detection and Staging of Prostate Cancer and Characterization of Prostate Tissues (PHS-02)

Resource links provided by NLM:


Further study details as provided by Advanced Medical Diagnostics s.a.:

Biospecimen Retention:   Samples Without DNA

paraffin blocks of prostate specimens


Enrollment: 52
Study Start Date: February 2008
Study Completion Date: June 2012
Groups/Cohorts
prostate cancer
Patients with histologically proven prostate cancer (positive biopsy) and who are planned to undergo radical prostatectomy.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

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

Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01191931

Locations
Belgium
Bordet Institute
Brussels, Belgium, 1000
UZ-Brussel
Brussels, Belgium, 1090
Czech Republic
Olomouc Hospital
Olomouc, Czech Republic, 775 20
Germany
Universitätsklinikum Tübingen
Tübingen, Germany, 72076
Hungary
Semmelweis University
Budapest, Hungary, H-1082
United Kingdom
Imperial College Healthcare NHS Trust, Charing Cross Hospital
Hammersmith, London, United Kingdom, W6 8RF
University College London Hospital (UCLH)
London, United Kingdom, NW1 2BU
Sponsors and Collaborators
Advanced Medical Diagnostics s.a.
Investigators
Study Director: Harry Bleiberg, MD
  More Information

Publications:

Responsible Party: Advanced Medical Diagnostics s.a.
ClinicalTrials.gov Identifier: NCT01191931     History of Changes
Other Study ID Numbers: CR2P00113
Study First Received: August 30, 2010
Last Updated: October 26, 2012
Health Authority: Belgium: Ethics Committee
Germany: Ethics Commission
Czech Republic: Ethics Committee
Hungary: Institutional Ethics Committee
United Kingdom: National Health Service

Additional relevant MeSH terms:
Prostatic Neoplasms
Genital Diseases, Male
Genital Neoplasms, Male
Neoplasms
Neoplasms by Site
Prostatic Diseases
Urogenital Neoplasms

ClinicalTrials.gov processed this record on November 25, 2014