Prostate Guided Biopsy Study Evaluating the Diagnostic Performance of Prostate HistoScanning

NCT ID: NCT01950871

Last Updated: 2015-01-05

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE4
• Total Enrollment: 80 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-10-31
• Study Completion Date: 2014-07-31

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.

Detailed Description

PHSTT-01 is a multi-center, prospective clinical trial to evaluate the diagnostic performance of prostate HistoScanning (HS) analysis in men at risk of PCa that have been scheduled for a first prostate biopsy. The purpose of this study is to determine if prostate HS analysis can improve the detection of clinically significant PCa, and potentially reduce the burden and number of biopsies in routine clinical practice. Subjects are men with serum total prostate-specific antigen (PCA) <= 20ng/mL (<= 10ng/mL if taking the 5-alpha reductase inhibitor).

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.

Conditions

Prostate Cancer

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Study Groups

single arm study

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.

Group Type: OTHER

Prostate HistoScanning

Intervention Type: 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.

Interventions

Prostate HistoScanning

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.

Intervention Type: DEVICE

Other Intervention Names

PHS/PHS TT

Eligibility Criteria

Inclusion Criteria

• 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

Exclusion Criteria

• 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: No

Sponsors

Advanced Medical Diagnostics s.a.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Bertrand Tombal, Prof

Role: PRINCIPAL_INVESTIGATOR

Cliniques Universitaires Saint-Luc, Brussels, Belgium

Locations

Krankenhaus der Barmherzigen Brüder

Vienna, , Austria

Medical Center Hanuschkrankenhaus

Vienna, , Austria

Medical Center Med.Landeskrankenhaus Vöcklabruck

Vöcklabruck, , Austria

University Medical Center UZ VUB

Brussels, Brussels Capital, Belgium

• University Medical Center Cliniques Universitaires Saint Luc

Brussels, Brussels Capital, Belgium

Medical Center Onze Lieve Vrouw Ziekenhuis OLVZ

Aalst, , Belgium

University Medical Center St. Marina University Hospital

Varna, , Bulgaria

Medical Center Urologická klinika - Fakultní nemocnice

Olomouc, , Czechia

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

Prague, , Czechia

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

Odense C, , Denmark

Medical Center North-Estonian Medical Center Foundation

Tallinn, , Estonia

Medical Center Institut Mutualiste Montouris

Paris, , France

University Medical Center CHU Saint Etienne

Saint-Etienne, , France

Medical Center Cancer Center - Prostatazentrum

Braunschweig, , Germany

Medical Center PAN Klinik

Cologne, , Germany

Medical Center Paracelsus Klinik

Düsseldorf, , Germany

Medical Center Martini Klinik - Prostate Cancer Center

Hamburg, , Germany

Medical Center Klinikum Herford

Herford, , Germany

Medical Center St. Elisabeth Krankenhaus

Leipzig, , Germany

Medical Center Klinikum Leverkusen

Leverkusen, , Germany

Medical Center Klinikum Wolfsburg Urologie

Wolfsburg, , Germany

Medical Center Uro-Clin Ltd

Pécs, , Hungary

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

Milan, , Italy

Medical Center URO

Riga, , Latvia

University Medical Center Vilniaus Universiteto Onkologijos Institutas - Santariškiu Clinics

Vilnius, , Lithuania

Medical Center Antoni Van Leeuwenhoek Ziekenhuis - Nederlands Kanker Instituut

Amsterdam, , Netherlands

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

Moscow, , Russia

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

Barcelona, , Spain

Carouge medical centre

Carouge, , Switzerland

Medical Center URO-TIP Urological Diagnosis Center

Istanbul, , Turkey (Türkiye)

Medical Center Acıbadem Kozyatağı Hospital

Istanbul, , Turkey (Türkiye)

Medical Center Blackpool Victoria Hospital

Blackpool, , United Kingdom

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

Bristol, , United Kingdom

Medical Center Spire Washington Hospital

Tyne and Wear, , United Kingdom

Countries

Austria; Belgium; Bulgaria; Czechia; Denmark; Estonia; France; Germany; Hungary; Italy; Latvia; Lithuania; Netherlands; Russia; Spain; Switzerland; Turkey (Türkiye); United Kingdom

Other Identifiers

DRKS00005263

Identifier Type: REGISTRY

Identifier Source: secondary_id

CR2P01127

Identifier Type: -

Identifier Source: org_study_id