Prostate Guided Biopsy Study Evaluating the Diagnostic Performance of Prostate HistoScanning

Prostate Cancer Clinical Trial

— PHSTT-01  

Official title:

Diagnostic Performance of Prostate HistoScanningTM (PHS) in Men at Risk of Prostate Cancer Scheduled for an Initial Prostate Biopsy

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01950871
• Other study ID #: CR2P01127
• Secondary ID: DRKS00005263
• Status: Terminated
• Phase: Phase 4
• First received: September 19, 2013
• Last updated: January 2, 2015
• Start date: October 2013
• Est. completion date: July 2014

Study information

• Verified date: January 2015
• Source: Advanced Medical Diagnostics s.a.
• Contact: n/a
• Is FDA regulated: No
• Health authority: Austria: EthikkommissionBelgium: Ethics CommitteeBulgaria: Ethics committeeCzech Republic: Ethics CommitteeDenmark: Ethics CommitteeEstonia: Research Ethics CommitteeFrance: Agence Nationale de Sécurité du Médicament et des produits de santéFrance: Committee for the Protection of PersonnesGermany: Ethics CommissionHungary: Research Ethics Medical CommitteeItaly: Ethics CommitteeLatvia: Institutional Review BoardLithuania: Bioethics CommitteeNetherlands: Medical Ethics Review Committee (METC)Russia: Ethics CommitteeSpain: Ethics CommitteeSwitzerland: EthikkommissionTurkey: Ethics CommitteeUnited Kingdom: National Health Service
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Terminated
• Enrollment: 80
• Est. completion date: July 2014
• Est. primary completion date: July 2014
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years and older

Eligibility

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

Study Design

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Related Conditions & MeSH terms

• Prostate Cancer
• Prostatic Neoplasms

Intervention

Device:
• 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.

Locations

Country	Name	City	State
Austria	Krankenhaus der Barmherzigen Brüder	Vienna
Austria	Medical Center Hanuschkrankenhaus	Vienna
Austria	Medical Center Med.Landeskrankenhaus Vöcklabruck	Vöcklabruck
Belgium	Medical Center Onze Lieve Vrouw Ziekenhuis OLVZ	Aalst
Belgium	• University Medical Center Cliniques Universitaires Saint Luc	Brussels
Belgium	University Medical Center UZ VUB	Brussels
Bulgaria	University Medical Center St. Marina University Hospital	Varna
Czech Republic	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
Denmark	• University Medical Center Urinary Tract Surgery - Urology Dpt - Odense Universitetshospital Svendborg Sygehus	Odense C
Estonia	Medical Center North-Estonian Medical Center Foundation	Tallinn
France	Medical Center Institut Mutualiste Montouris	Paris
France	University Medical Center CHU Saint Etienne	Saint Etienne
Germany	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
Hungary	Medical Center Uro-Clin Ltd	Pécs
Italy	University Medical Center University Vita-Salute, Scientific Institute H. San Raffaele	Milano
Latvia	Medical Center URO	Riga
Lithuania	University Medical Center Vilniaus Universiteto Onkologijos Institutas - Santariškiu Clinics	Vilnius
Netherlands	Medical Center Antoni Van Leeuwenhoek Ziekenhuis - Nederlands Kanker Instituut	Amsterdam
Russian Federation	University Medical Center Moscow State University of Medicine and Dentistry named after A.I.Evdokimov	Moscow
Spain	University Medical Center Vall d'Hebron University Hospital - Autonoma Universitat Barcelona	Barcelona
Switzerland	Carouge medical centre	Carouge
Turkey	Medical Center Acibadem Kozyatagi Hospital	Istanbul
Turkey	Medical Center URO-TIP Urological Diagnosis Center	Istanbul
United Kingdom	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

Sponsors (1)

Lead Sponsor	Collaborator
Advanced Medical Diagnostics s.a.

Countries where clinical trial is conducted

Austria,  Belgium,  Bulgaria,  Czech Republic,  Denmark,  Estonia,  France,  Germany,  Hungary,  Italy,  Latvia,  Lithuania,  Netherlands,  Russian Federation,  Spain,  Switzerland,  Turkey,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	Diagnostic performance of prostate HS to identify PCa using histology outcomes from systematic Bx as reference	Compare prostate HS results to the systematic Bx outcome (positive or negative) for all PCa in the non-run-in population.	1 year	No
Secondary	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	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.	1 year	No
Secondary	Difference in detection rates of clinically significant PCa between systematic and HS-guided biopsy.	Compared PCa detection rates of systematic and HS-guided prostate Bx in the non-run-in population.	1 year	No

External Links

•   Deutsche Register für klinische Studien (DRKS)