Prostate Guided Biopsy Study Evaluating the Diagnostic Performance of Prostate HistoScanning

NCT01950871 | Terminated Phase 4

• 2 other identifiers: CR2P01127DRKS00005263
• Study Type: interventional
• Target: 80
• Locations: 17 countries
• Sites: 33

Brief Summary

The primary objective of the PHSTT-01 trial is to determine if prostate HistoScanning (HS) analysis can be used to improve the detection of clinically significant prostate cancer (PCa), and potentially reduce the burden and number of biopsies in routine clinical practice. Prostate HS is an ultrasound-based tissue characterization technology specifically developed to detect, visualize, and locate tissue suspected of harboring PCa. These suspicious tissues are displayed as red areas on an imaging monitor. Recently a new biopsy guidance tool has been developed that uses the results of the prostate HS analysis. The subjects that will participate in this study are all scheduled for a first biopsy of the prostate. They will initially be imaged using transrectal ultrasound (TRUS) to obtain data for prostate HS analysis. The results of HS analysis will be used later in the procedure. Subjects will then undergo a routine systematic 10- to 12-core biopsy procedure using TRUS. This will be followed by a TRUS-guided biopsy that uses the result of prostate HS analysis and new biopsy guidance tool.

Conditions

Prostate Cancer

Keywords

HistoScanning; TRUS; Prostate cancer; Biopsy guidance

Outcome Measures

Primary Outcomes (1)

• Diagnostic performance of prostate HistoScanning (HS) to identify clinically significant PCa using histology outcomes from systematic prostate biopsy (Bx) as reference

  Compare prostate HS results to the systematic Bx outcome (positive or negative) for clinically significant PCa (defined as Gleason sum ≥ 7) in the non-run-in population.

  1 year

Secondary Outcomes (3)

• Diagnostic performance of prostate HS to identify PCa using histology outcomes from systematic Bx as reference

  1 year

• Diagnostic performance of prostate HS to identify clinically significant PCa using a combination of outcomes of both systematic Bx and HS-guided biopsy histology as reference

  1 year

• Difference in detection rates of clinically significant PCa between systematic and HS-guided biopsy.

  1 year

Study Arms (1)

single arm study

OTHER

Prostate HistoScanning (HS) analysis with HS-guided biopsy will be used to sample two cores per suspicious area (displayed as red on an imaging monitor), up to a maximum of 3 suspicious areas per subject. Depending on the number of suspicious areas identified by prostate HS, the number of cores will be zero (if no suspicious area is identified) up to a maximum of 6 cores.

Device: Prostate HistoScanning

Interventions

Prostate HistoScanning DEVICE

In a single visit, subjects will first be imaged with TRUS for the purpose of generating data for prostate HS analysis. The results of HS analysis will be used later in the procedure. Subjects will then undergo two consecutive biopsy procedures. First, using TRUS, a systematic 10- to 12-core biopsy procedure will be performed. In turn, prostate HS data taken at the beginning of the procedure will be used to determine suspicious areas (displayed as red on an imaging monitor) and used to guide the biopsy procedure. Areas that are identified as suspicious (zero to a maximum of 3 areas) will then be sampled with two biopsy cores. Depending on the number of suspicious areas identified by prostate HS, the number of cores will be zero to a maximum of 6 cores.

Also known as: PHS/PHS TT

single arm study

Eligibility Criteria

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

You may qualify if:

• Men at risk of PCa scheduled for first biopsy with serum total PSA
• ≤ 20 ng/ml (≤ 10 ng/mL if taking 5-alpha reductase inhibitors) from maximally 3 months ago
• Signed informed consent

You may not qualify if:

• Previous prostate biopsy
• Confirmed PCa
• PSA \> 20 ng/ml (or \> 10 ng/mL if taking 5-alpha reductase inhibitors)
• Active urinary tract infection
• Presence/history of any confirmed cancer
• Recent prostatic surgery (past 6 months)
• History of pelvic radiotherapy

Sponsors & Collaborators

• Advanced Medical Diagnostics s.a.: lead

Study Sites (34)

Krankenhaus der Barmherzigen Brüder

Vienna, 1020, Austria

Location

Medical Center Hanuschkrankenhaus

Vienna, 1140, Austria

Location

Medical Center Med.Landeskrankenhaus Vöcklabruck

Vöcklabruck, 4840, Austria

Location

University Medical Center UZ VUB

Brussels, Brussels Capital, 1090, Belgium

Location

• University Medical Center Cliniques Universitaires Saint Luc

Brussels, Brussels Capital, 1200, Belgium

Location

Medical Center Onze Lieve Vrouw Ziekenhuis OLVZ

Aalst, 9300, Belgium

Location

University Medical Center St. Marina University Hospital

Varna, 9010, Bulgaria

Location

Medical Center Urologická klinika - Fakultní nemocnice

Olomouc, 775 20, Czechia

Location

University Medical Center Všeobecná fakultní nemocnice v Praze (VFN) a 1. -General University Hospital and First Faculty of Medicine Charles University

Prague, 15006, Czechia

Location

• University Medical Center Urinary Tract Surgery - Urology Dpt - Odense Universitetshospital Svendborg Sygehus

Odense C, 5000, Denmark

Location

Medical Center North-Estonian Medical Center Foundation

Tallinn, 13419, Estonia

Location

Medical Center Institut Mutualiste Montouris

Paris, 75014, France

Location

University Medical Center CHU Saint Etienne

Saint-Etienne, 42055, France

Location

Medical Center Cancer Center - Prostatazentrum

Braunschweig, 38126, Germany

Location

Medical Center PAN Klinik

Cologne, 50667, Germany

Location

Medical Center Paracelsus Klinik

Düsseldorf, 40474, Germany

Location

Medical Center Martini Klinik - Prostate Cancer Center

Hamburg, 20246, Germany

Location

Medical Center Klinikum Herford

Herford, 32049, Germany

Location

Medical Center St. Elisabeth Krankenhaus

Leipzig, 04277, Germany

Location

Medical Center Klinikum Leverkusen

Leverkusen, 51375, Germany

Location

Medical Center Klinikum Wolfsburg Urologie

Wolfsburg, 38440, Germany

Location

Medical Center Uro-Clin Ltd

Pécs, 7601 Pf. 246, Hungary

Location

University Medical Center University Vita-Salute, Scientific Institute H. San Raffaele

Milan, 20132, Italy

Location

Medical Center URO

Riga, 1006, Latvia

Location

University Medical Center Vilniaus Universiteto Onkologijos Institutas - Santariškiu Clinics

Vilnius, 08406, Lithuania

Location

Medical Center Antoni Van Leeuwenhoek Ziekenhuis - Nederlands Kanker Instituut

Amsterdam, 1066 CX, Netherlands

Location

University Medical Center Moscow State University of Medicine and Dentistry named after A.I.Evdokimov

Moscow, 127473, Russia

Location

University Medical Center Vall d'Hebron University Hospital - Autonoma Universitat Barcelona

Barcelona, 08035, Spain

Location

Carouge medical centre

Carouge, 1227, Switzerland

Location

Medical Center URO-TIP Urological Diagnosis Center

Istanbul, 34740, Turkey (Türkiye)

Location

Medical Center Acıbadem Kozyatağı Hospital

Istanbul, 34742, Turkey (Türkiye)

Location

Medical Center Blackpool Victoria Hospital

Blackpool, FY38NR, United Kingdom

Location

University Medical Center Nuffield Health - University Hospitals Bristol (UHB) - Bristol Royal Infirmary and Southmead Hospitals

Bristol, BS28HW, United Kingdom

Location

Medical Center Spire Washington Hospital

Tyne and Wear, NE38 9JZ, United Kingdom

Location

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

• Bertrand Tombal, Prof

  Cliniques Universitaires Saint-Luc, Brussels, Belgium

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 19, 2013
• First Posted: September 26, 2013
• Study Start: October 1, 2013
• Primary Completion: July 1, 2014
• Study Completion: July 1, 2014
• Last Updated: January 5, 2015

Record last verified: 2015-01

Locations

IT (1); HU (1); ES (1); FR (2); CH (1); LI (1); TU (2); GB (3); CZ (2); LA (1); NL (1); DE (8); DK (1); RU (1); BU (1); AU (3); BE (3)