Prostate Guided Biopsy Study Evaluating the Diagnostic Performance of Prostate HistoScanning
- Conditions
- Prostate Cancer
- Interventions
- Device: Prostate HistoScanning
- Registration Number
- NCT01950871
- Lead Sponsor
- Advanced Medical Diagnostics s.a.
- 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.
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- Male
- Target Recruitment
- 80
-
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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description single arm study Prostate HistoScanning 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.
- Primary Outcome Measures
Name Time Method Diagnostic performance of prostate HistoScanning (HS) to identify clinically significant PCa using histology outcomes from systematic prostate biopsy (Bx) as reference 1 year 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.
- Secondary Outcome Measures
Name Time Method Diagnostic performance of prostate HS to identify PCa using histology outcomes from systematic Bx as reference 1 year Compare prostate HS results to the systematic Bx outcome (positive or negative) for all PCa in the non-run-in population.
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 Compare prostate HS results to the combination of systematic and HS-guided Bx outcomes (positive or negative) for clinically significant PCa (defined as Gleason sum ≥ 7) in the non-run-in population.
Difference in detection rates of clinically significant PCa between systematic and HS-guided biopsy. 1 year Compared PCa detection rates of systematic and HS-guided prostate Bx in the non-run-in population.
Trial Locations
- Locations (34)
Krankenhaus der Barmherzigen Brüder
🇦🇹Vienna, Austria
Medical Center Urologická klinika - Fakultní nemocnice
🇨🇿Olomouc, Czech Republic
University Medical Center Všeobecná fakultní nemocnice v Praze (VFN) a 1. -General University Hospital and First Faculty of Medicine Charles University
🇨🇿Praha, Czech Republic
Medical Center North-Estonian Medical Center Foundation
🇪🇪Tallinn, Estonia
Medical Center URO-TIP Urological Diagnosis Center
🇹🇷Istanbul, Turkey
Medical Center Spire Washington Hospital
🇬🇧Tyne and Wear, United Kingdom
Medical Center Hanuschkrankenhaus
🇦🇹Vienna, Austria
Medical Center Med.Landeskrankenhaus Vöcklabruck
🇦🇹Vöcklabruck, Austria
Medical Center Onze Lieve Vrouw Ziekenhuis OLVZ
🇧🇪Aalst, Belgium
University Medical Center UZ VUB
🇧🇪Brussels, Belgium
• University Medical Center Cliniques Universitaires Saint Luc
🇧🇪Brussels, Belgium
• University Medical Center Urinary Tract Surgery - Urology Dpt - Odense Universitetshospital Svendborg Sygehus
🇩🇰Odense C, Denmark
Medical Center Institut Mutualiste Montouris
🇫🇷Paris, France
University Medical Center CHU Saint Etienne
🇫🇷Saint Etienne, France
University Medical Center St. Marina University Hospital
🇧🇬Varna, Bulgaria
Medical Center Cancer Center - Prostatazentrum
🇩🇪Braunschweig, Germany
Medical Center Antoni Van Leeuwenhoek Ziekenhuis - Nederlands Kanker Instituut
🇳🇱Amsterdam, Netherlands
University Medical Center University Vita-Salute, Scientific Institute H. San Raffaele
🇮🇹Milano, Italy
Medical Center Klinikum Herford
🇩🇪Herford, Germany
Medical Center PAN Klinik
🇩🇪Köln, Germany
Medical Center Uro-Clin Ltd
🇭🇺Pécs, Hungary
Medical Center URO
🇱🇻Riga, Latvia
University Medical Center Vilniaus Universiteto Onkologijos Institutas - Santariškiu Clinics
🇱🇹Vilnius, Lithuania
Carouge medical centre
🇨🇭Carouge, Switzerland
University Medical Center Moscow State University of Medicine and Dentistry named after A.I.Evdokimov
🇷🇺Moscow, Russian Federation
Medical Center Klinikum Leverkusen
🇩🇪Leverkusen, Germany
Medical Center Klinikum Wolfsburg Urologie
🇩🇪Wolfsburg, Germany
Medical Center Acıbadem Kozyatağı Hospital
🇹🇷Istanbul, Turkey
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
University Medical Center Vall d'Hebron University Hospital - Autonoma Universitat Barcelona
🇪🇸Barcelona, Spain
Medical Center Paracelsus Klinik
🇩🇪Düsseldorf, Germany
Medical Center St. Elisabeth Krankenhaus
🇩🇪Leipzig, Germany
Medical Center Martini Klinik - Prostate Cancer Center
🇩🇪Hamburg, Germany