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

NCT01191931 | Completed DMC

• 1 other identifier: CR2P00113
• Study Type: observational
• Target: 52
• Locations: 5 countries
• Sites: 7

Brief Summary

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.

Conditions

Prostate Cancer

Study Arms (1)

prostate cancer

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

Eligibility Criteria

• Age: 18 Years+
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Advanced Medical Diagnostics s.a.: lead

Study Sites (7)

Bordet Institute

Brussels, Brussels Capital, 1000, Belgium

Location

UZ-Brussel

Brussels, Brussels Capital, 1090, Belgium

Location

Olomouc Hospital

Olomouc, 775 20, Czechia

Location

Universitätsklinikum Tübingen

Tübingen, Tübingen, 72076, Germany

Location

Semmelweis University

Budapest, Budapest, H-1082, Hungary

Location

Imperial College Healthcare NHS Trust, Charing Cross Hospital

Hammersmith, London, W6 8RF, United Kingdom

Location

University College London Hospital (UCLH)

London, NW1 2BU, United Kingdom

Location

Related Publications (6)

• Braeckman J, Autier P, Garbar C, Marichal MP, Soviany C, Nir R, Nir D, Michielsen D, Bleiberg H, Egevad L, Emberton M. Computer-aided ultrasonography (HistoScanning): a novel technology for locating and characterizing prostate cancer. BJU Int. 2008 Feb;101(3):293-8. doi: 10.1111/j.1464-410X.2007.07232.x. Epub 2007 Oct 8.

  PMID: 17922870 BACKGROUND

• Braeckman J, Autier P, Soviany C, Nir R, Nir D, Michielsen D, Treurnicht K, Jarmulowicz M, Bleiberg H, Govindaraju S, Emberton M. The accuracy of transrectal ultrasonography supplemented with computer-aided ultrasonography for detecting small prostate cancers. BJU Int. 2008 Dec;102(11):1560-5. doi: 10.1111/j.1464-410X.2008.07878.x. Epub 2008 Aug 14.

  PMID: 18710457 BACKGROUND

• Lucidarme O, Akakpo JP, Granberg S, Sideri M, Levavi H, Schneider A, Autier P, Nir D, Bleiberg H; Ovarian HistoScanning Clinical Study Group. A new computer-aided diagnostic tool for non-invasive characterisation of malignant ovarian masses: results of a multicentre validation study. Eur Radiol. 2010 Aug;20(8):1822-30. doi: 10.1007/s00330-010-1750-6. Epub 2010 Mar 20.

  PMID: 20306081 BACKGROUND

• Vaes E, Manchanda R, Nir R, Nir D, Bleiberg H, Autier P, Menon U, Robert A. Mathematical models to discriminate between benign and malignant adnexal masses: potential diagnostic improvement using ovarian HistoScanning. Int J Gynecol Cancer. 2011 Jan;21(1):35-43. doi: 10.1097/IGC.0b013e3182000528.

  PMID: 21330829 BACKGROUND

• Salomon G, Spethmann J, Beckmann A, Autier P, Moore C, Durner L, Sandmann M, Haese A, Schlomm T, Michl U, Heinzer H, Graefen M, Steuber T. Accuracy of HistoScanning for the prediction of a negative surgical margin in patients undergoing radical prostatectomy. BJU Int. 2013 Jan;111(1):60-6. doi: 10.1111/j.1464-410X.2012.11396.x. Epub 2012 Aug 9.

  PMID: 22882794 BACKGROUND

• Simmons LA, Autier P, Zat'ura F, Braeckman J, Peltier A, Romic I, Stenzl A, Treurnicht K, Walker T, Nir D, Moore CM, Emberton M. Detection, localisation and characterisation of prostate cancer by prostate HistoScanning(). BJU Int. 2012 Jul;110(1):28-35. doi: 10.1111/j.1464-410X.2011.10734.x. Epub 2011 Nov 17.

  PMID: 22093966 RESULT

Biospecimen

Retention: SAMPLES WITHOUT DNA

paraffin blocks of prostate specimens

MeSH Terms

Conditions

Prostatic Neoplasms

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases

Study Officials

• Harry Bleiberg, MD

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 30, 2010
• First Posted: August 31, 2010
• Study Start: February 1, 2008
• Study Completion: June 1, 2012
• Last Updated: October 29, 2012

Record last verified: 2012-10

Locations

BE (2); CZ (1); GB (2); HU (1); DE (1)