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Prostate Guided Biopsy Study Evaluating the Diagnostic Performance of Prostate HistoScanning (PHSTT-01)

Primary Purpose

Prostate Cancer

Status
Terminated
Phase
Phase 4
Locations
International
Study Type
Interventional
Intervention
Prostate HistoScanning
Sponsored by
Advanced Medical Diagnostics s.a.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Prostate Cancer focused on measuring HistoScanning, TRUS, Prostate cancer, Biopsy guidance

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)MaleDoes not accept healthy volunteers

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

Sites / Locations

  • Krankenhaus der Barmherzigen Brüder
  • Medical Center Hanuschkrankenhaus
  • Medical Center Med.Landeskrankenhaus Vöcklabruck
  • Medical Center Onze Lieve Vrouw Ziekenhuis OLVZ
  • University Medical Center UZ VUB
  • • University Medical Center Cliniques Universitaires Saint Luc
  • University Medical Center St. Marina University Hospital
  • Medical Center Urologická klinika - Fakultní nemocnice
  • University Medical Center Všeobecná fakultní nemocnice v Praze (VFN) a 1. -General University Hospital and First Faculty of Medicine Charles University
  • • University Medical Center Urinary Tract Surgery - Urology Dpt - Odense Universitetshospital Svendborg Sygehus
  • Medical Center North-Estonian Medical Center Foundation
  • Medical Center Institut Mutualiste Montouris
  • University Medical Center CHU Saint Etienne
  • Medical Center Cancer Center - Prostatazentrum
  • Medical Center Paracelsus Klinik
  • Medical Center Martini Klinik - Prostate Cancer Center
  • Medical Center Klinikum Herford
  • Medical Center PAN Klinik
  • Medical Center St. Elisabeth Krankenhaus
  • Medical Center Klinikum Leverkusen
  • Medical Center Klinikum Wolfsburg Urologie
  • Medical Center Uro-Clin Ltd
  • University Medical Center University Vita-Salute, Scientific Institute H. San Raffaele
  • Medical Center URO
  • University Medical Center Vilniaus Universiteto Onkologijos Institutas - Santariškiu Clinics
  • Medical Center Antoni Van Leeuwenhoek Ziekenhuis - Nederlands Kanker Instituut
  • University Medical Center Moscow State University of Medicine and Dentistry named after A.I.Evdokimov
  • University Medical Center Vall d'Hebron University Hospital - Autonoma Universitat Barcelona
  • Carouge medical centre
  • Medical Center URO-TIP Urological Diagnosis Center
  • Medical Center Acıbadem Kozyatağı Hospital
  • Medical Center Blackpool Victoria Hospital
  • University Medical Center Nuffield Health - University Hospitals Bristol (UHB) - Bristol Royal Infirmary and Southmead Hospitals
  • Medical Center Spire Washington Hospital

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

single arm study

Arm Description

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.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.
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.
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.

Full Information

First Posted
September 19, 2013
Last Updated
January 2, 2015
Sponsor
Advanced Medical Diagnostics s.a.
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1. Study Identification

Unique Protocol Identification Number
NCT01950871
Brief Title
Prostate Guided Biopsy Study Evaluating the Diagnostic Performance of Prostate HistoScanning
Acronym
PHSTT-01
Official Title
Diagnostic Performance of Prostate HistoScanningTM (PHS) in Men at Risk of Prostate Cancer Scheduled for an Initial Prostate Biopsy
Study Type
Interventional

2. Study Status

Record Verification Date
January 2015
Overall Recruitment Status
Terminated
Why Stopped
Sponsor is bankrupt
Study Start Date
October 2013 (undefined)
Primary Completion Date
July 2014 (Actual)
Study Completion Date
July 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Advanced Medical Diagnostics s.a.

4. Oversight

Data Monitoring Committee
No

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Prostate Cancer
Keywords
HistoScanning, TRUS, Prostate cancer, Biopsy guidance

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
80 (Actual)

8. Arms, Groups, and Interventions

Arm Title
single arm study
Arm Type
Other
Arm Description
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.
Intervention Type
Device
Intervention Name(s)
Prostate HistoScanning
Other Intervention Name(s)
PHS/PHS TT
Intervention Description
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.
Primary Outcome Measure Information:
Title
Diagnostic performance of prostate HistoScanning (HS) to identify clinically significant PCa using histology outcomes from systematic prostate biopsy (Bx) as reference
Description
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.
Time Frame
1 year
Secondary Outcome Measure Information:
Title
Diagnostic performance of prostate HS to identify PCa using histology outcomes from systematic Bx as reference
Description
Compare prostate HS results to the systematic Bx outcome (positive or negative) for all PCa in the non-run-in population.
Time Frame
1 year
Title
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
Description
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.
Time Frame
1 year
Title
Difference in detection rates of clinically significant PCa between systematic and HS-guided biopsy.
Description
Compared PCa detection rates of systematic and HS-guided prostate Bx in the non-run-in population.
Time Frame
1 year

10. Eligibility

Sex
Male
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Bertrand Tombal, Prof
Organizational Affiliation
Cliniques Universitaires Saint-Luc, Brussels, Belgium
Official's Role
Principal Investigator
Facility Information:
Facility Name
Krankenhaus der Barmherzigen Brüder
City
Vienna
ZIP/Postal Code
1020
Country
Austria
Facility Name
Medical Center Hanuschkrankenhaus
City
Vienna
ZIP/Postal Code
1140
Country
Austria
Facility Name
Medical Center Med.Landeskrankenhaus Vöcklabruck
City
Vöcklabruck
ZIP/Postal Code
4840
Country
Austria
Facility Name
Medical Center Onze Lieve Vrouw Ziekenhuis OLVZ
City
Aalst
ZIP/Postal Code
9300
Country
Belgium
Facility Name
University Medical Center UZ VUB
City
Brussels
ZIP/Postal Code
1090
Country
Belgium
Facility Name
• University Medical Center Cliniques Universitaires Saint Luc
City
Brussels
ZIP/Postal Code
1200
Country
Belgium
Facility Name
University Medical Center St. Marina University Hospital
City
Varna
ZIP/Postal Code
9010
Country
Bulgaria
Facility Name
Medical Center Urologická klinika - Fakultní nemocnice
City
Olomouc
ZIP/Postal Code
775 20
Country
Czech Republic
Facility Name
University Medical Center Všeobecná fakultní nemocnice v Praze (VFN) a 1. -General University Hospital and First Faculty of Medicine Charles University
City
Praha
ZIP/Postal Code
15006
Country
Czech Republic
Facility Name
• University Medical Center Urinary Tract Surgery - Urology Dpt - Odense Universitetshospital Svendborg Sygehus
City
Odense C
ZIP/Postal Code
5000
Country
Denmark
Facility Name
Medical Center North-Estonian Medical Center Foundation
City
Tallinn
ZIP/Postal Code
13419
Country
Estonia
Facility Name
Medical Center Institut Mutualiste Montouris
City
Paris
ZIP/Postal Code
75014
Country
France
Facility Name
University Medical Center CHU Saint Etienne
City
Saint Etienne
ZIP/Postal Code
42055
Country
France
Facility Name
Medical Center Cancer Center - Prostatazentrum
City
Braunschweig
ZIP/Postal Code
38126
Country
Germany
Facility Name
Medical Center Paracelsus Klinik
City
Düsseldorf
ZIP/Postal Code
40474
Country
Germany
Facility Name
Medical Center Martini Klinik - Prostate Cancer Center
City
Hamburg
ZIP/Postal Code
20246
Country
Germany
Facility Name
Medical Center Klinikum Herford
City
Herford
ZIP/Postal Code
32049
Country
Germany
Facility Name
Medical Center PAN Klinik
City
Köln
ZIP/Postal Code
50667
Country
Germany
Facility Name
Medical Center St. Elisabeth Krankenhaus
City
Leipzig
ZIP/Postal Code
04277
Country
Germany
Facility Name
Medical Center Klinikum Leverkusen
City
Leverkusen
ZIP/Postal Code
51375
Country
Germany
Facility Name
Medical Center Klinikum Wolfsburg Urologie
City
Wolfsburg
ZIP/Postal Code
38440
Country
Germany
Facility Name
Medical Center Uro-Clin Ltd
City
Pécs
ZIP/Postal Code
7601 Pf. 246
Country
Hungary
Facility Name
University Medical Center University Vita-Salute, Scientific Institute H. San Raffaele
City
Milano
ZIP/Postal Code
20132
Country
Italy
Facility Name
Medical Center URO
City
Riga
ZIP/Postal Code
1006
Country
Latvia
Facility Name
University Medical Center Vilniaus Universiteto Onkologijos Institutas - Santariškiu Clinics
City
Vilnius
ZIP/Postal Code
08406
Country
Lithuania
Facility Name
Medical Center Antoni Van Leeuwenhoek Ziekenhuis - Nederlands Kanker Instituut
City
Amsterdam
ZIP/Postal Code
1066 CX
Country
Netherlands
Facility Name
University Medical Center Moscow State University of Medicine and Dentistry named after A.I.Evdokimov
City
Moscow
ZIP/Postal Code
127473
Country
Russian Federation
Facility Name
University Medical Center Vall d'Hebron University Hospital - Autonoma Universitat Barcelona
City
Barcelona
ZIP/Postal Code
08035
Country
Spain
Facility Name
Carouge medical centre
City
Carouge
ZIP/Postal Code
1227
Country
Switzerland
Facility Name
Medical Center URO-TIP Urological Diagnosis Center
City
Istanbul
ZIP/Postal Code
34740
Country
Turkey
Facility Name
Medical Center Acıbadem Kozyatağı Hospital
City
Istanbul
ZIP/Postal Code
34742
Country
Turkey
Facility Name
Medical Center Blackpool Victoria Hospital
City
Blackpool
ZIP/Postal Code
FY38NR
Country
United Kingdom
Facility Name
University Medical Center Nuffield Health - University Hospitals Bristol (UHB) - Bristol Royal Infirmary and Southmead Hospitals
City
Bristol
ZIP/Postal Code
BS28HW
Country
United Kingdom
Facility Name
Medical Center Spire Washington Hospital
City
Tyne and Wear
ZIP/Postal Code
NE38 9JZ
Country
United Kingdom

12. IPD Sharing Statement

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Prostate Guided Biopsy Study Evaluating the Diagnostic Performance of Prostate HistoScanning

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