Clinical trial NCT01950871: Prostate Guided Biopsy Study Evaluating the Diagnostic Performance of Prostate HistoScanning
Official title: Diagnostic Performance of Prostate HistoScanningTM (PHS) in Men at Risk of Prostate Cancer Scheduled for an Initial Prostate Biopsy
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE4
Conditions: Prostate Cancer
Keywords: HistoScanning
TRUS
Prostate cancer
Biopsy guidance
Lead sponsor: Advanced Medical Diagnostics s.a.
Sponsor class: INDUSTRY
First posted: 2013-09-26
Enrollment: 80
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

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.

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

Primary outcomes:
measure: Diagnostic performance of prostate HistoScanning (HS) to identify clinically significant PCa using histology outcomes from systematic prostate biopsy (Bx) as reference
timeFrame: 1 year
Secondary outcomes:
measure: Diagnostic performance of prostate HS to identify PCa using histology outcomes from systematic Bx as reference
timeFrame: 1 year
measure: 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
timeFrame: 1 year
measure: Difference in detection rates of clinically significant PCa between systematic and HS-guided biopsy.
timeFrame: 1 year
Other outcomes:
Locations:
city: Vienna
country: Austria
facility: Krankenhaus der Barmherzigen Brüder
city: Vienna
country: Austria
facility: Medical Center Hanuschkrankenhaus
city: Vöcklabruck
country: Austria
facility: Medical Center Med.Landeskrankenhaus Vöcklabruck
city: Aalst
country: Belgium
facility: Medical Center Onze Lieve Vrouw Ziekenhuis OLVZ
city: Brussels
country: Belgium
facility: University Medical Center UZ VUB
city: Brussels
country: Belgium
facility: • University Medical Center Cliniques Universitaires Saint Luc
city: Varna
country: Bulgaria
facility: University Medical Center St. Marina University Hospital
city: Olomouc
country: Czech Republic
facility: Medical Center Urologická klinika - Fakultní nemocnice
city: Praha
country: Czech Republic
facility: University Medical Center Všeobecná fakultní nemocnice v Praze (VFN) a 1. -General University Hospital and First Faculty of Medicine Charles University
city: Odense C
country: Denmark
facility: • University Medical Center Urinary Tract Surgery - Urology Dpt - Odense Universitetshospital Svendborg Sygehus
city: Tallinn
country: Estonia
facility: Medical Center North-Estonian Medical Center Foundation
city: Paris
country: France
facility: Medical Center Institut Mutualiste Montouris
city: Saint Etienne
country: France
facility: University Medical Center CHU Saint Etienne
city: Braunschweig
country: Germany
facility: Medical Center Cancer Center - Prostatazentrum
city: Düsseldorf
country: Germany
facility: Medical Center Paracelsus Klinik
city: Hamburg
country: Germany
facility: Medical Center Martini Klinik - Prostate Cancer Center
city: Herford
country: Germany
facility: Medical Center Klinikum Herford
city: Köln
country: Germany
facility: Medical Center PAN Klinik
city: Leipzig
country: Germany
facility: Medical Center St. Elisabeth Krankenhaus
city: Leverkusen
country: Germany
facility: Medical Center Klinikum Leverkusen
city: Wolfsburg
country: Germany
facility: Medical Center Klinikum Wolfsburg Urologie
city: Pécs
country: Hungary
facility: Medical Center Uro-Clin Ltd
city: Milano
country: Italy
facility: University Medical Center University Vita-Salute, Scientific Institute H. San Raffaele
city: Riga
country: Latvia
facility: Medical Center URO
city: Vilnius
country: Lithuania
facility: University Medical Center Vilniaus Universiteto Onkologijos Institutas - Santariškiu Clinics
city: Amsterdam
country: Netherlands
facility: Medical Center Antoni Van Leeuwenhoek Ziekenhuis - Nederlands Kanker Instituut
city: Moscow
country: Russian Federation
facility: University Medical Center Moscow State University of Medicine and Dentistry named after A.I.Evdokimov
city: Barcelona
country: Spain
facility: University Medical Center Vall d'Hebron University Hospital - Autonoma Universitat Barcelona
city: Carouge
country: Switzerland
facility: Carouge medical centre
city: Istanbul
country: Turkey
facility: Medical Center URO-TIP Urological Diagnosis Center
city: Istanbul
country: Turkey
facility: Medical Center Acıbadem Kozyatağı Hospital
city: Blackpool
country: United Kingdom
facility: Medical Center Blackpool Victoria Hospital
city: Bristol
country: United Kingdom
facility: University Medical Center Nuffield Health - University Hospitals Bristol (UHB) - Bristol Royal Infirmary and Southmead Hospitals
city: Tyne and Wear
country: United Kingdom
facility: Medical Center Spire Washington Hospital
Study officials:
affiliation: Cliniques Universitaires Saint-Luc, Brussels, Belgium
name: Bertrand Tombal, Prof
role: PRINCIPAL_INVESTIGATOR
References: