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Spots Global Cancer Trial Database for Prostate Guided Biopsy Study Evaluating the Diagnostic Performance of Prostate HistoScanning

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Trial Identification

Brief Title: 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 ID: NCT01950871

Conditions

Prostate Cancer

Study Description

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

Minimum Age: 18 Years

Eligible Ages: ADULT, OLDER_ADULT

Sex: MALE

Healthy Volunteers: No

Locations

Krankenhaus der Barmherzigen Brüder, Vienna, , Austria

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 St. Marina University Hospital, Varna, , Bulgaria

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

• 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 Paracelsus Klinik, Düsseldorf, , Germany

Medical Center Martini Klinik - Prostate Cancer Center, Hamburg, , Germany

Medical Center Klinikum Herford, Herford, , Germany

Medical Center PAN Klinik, Köln, , 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, Milano, , 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, , Russian Federation

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

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

Medical Center Spire Washington Hospital, Tyne and Wear, , United Kingdom

Contact Details

Name: Bertrand Tombal, Prof

Affiliation: Cliniques Universitaires Saint-Luc, Brussels, Belgium

Role: PRINCIPAL_INVESTIGATOR

Useful links and downloads for this trial

Clinicaltrials.gov

Google Search Results

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