Trial document




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  DRKS00005263

Trial Description

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Title

Diagnostic performance of Prostate HistoScanningTM (PHS) in men at risk of prostate cancer scheduled for an initial prostate biopsy.

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Trial Acronym

PHSTT-01

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URL of the Trial

[---]*

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Brief Summary in Lay Language

The primary objective of the PHSTT-01 trial is to determine if prostate HistoScanning (HS) analysis can be used 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.

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Brief Summary in Scientific Language

PHSTT-01 is a multi-center, prospective clinical trial to evaluate the diagnostic performance of prostate 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.

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Organizational Data

  •   DRKS00005263
  •   2014/03/13
  •   2013/09/19
  •   no
  •   Approved
  •   EK-BR-78/13-1, Ethikkommission bei der Sächsischen Landesärztekammer
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Secondary IDs

  •   NCT01950871  (ClinicalTrial.gov)
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Health Condition or Problem studied

  •   Subjects suspected to have PCa who are schedules for a first prostate biopsy.
  •   C61 -  Malignant neoplasm of prostate
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Interventions/Observational Groups

  •   Prostate HistoScanning (HS) analysis with HS-guided biopsy will 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.
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Characteristics

  •   Interventional
  •   [---]*
  •   Single arm study
  •   Open (masking not used)
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  •   Uncontrolled/Single arm
  •   Screening
  •   Single (group)
  •   N/A
  •   N/A
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Primary Outcome


Diagnostic performance of prostate HS to identify clinically significant PCa using prostate biopsy histology from systematic biopsy as reference: receiver operating characteristic (ROC) curve, area under the ROC curve (AUC), sensitivity, specificity, positive predictive value (PPV), negative predictive value (NPV).

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Secondary Outcome

Diagnostic performance of prostate HS to identify PCa using prostate biopsy histology from systematic biopsy as reference: receiver operating characteristic (ROC) curve, area under the ROC curve (AUC), sensitivity, specificity, positive predictive value (PPV), negative predictive value (NPV).

Diagnostic performance of prostate HS to identify clinically significant PCa using a combination of outcomes of both systematic biopsy and HS guided biopsy histology as reference: receiver operating characteristic (ROC) curve, area under the ROC curve (AUC), sensitivity, specificity, positive predictive value (PPV), negative predictive value (NPV).

Difference in detection rates of clinically significant PCa between systematic and prostate HS guided biopsy.

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Countries of Recruitment

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

  • University Medical Center 
  • University Medical Center 
  • Medical Center 
  • Medical Center 
  • Medical Center 
  • Medical Center 
  • Medical Center 
  • Medical Center 
  • Medical Center 
  • Medical Center 
  • Medical Center 
  • Medical Center 
  • University Medical Center 
  • Medical Center 
  • Medical Center 
  • Medical Center 
  • University Medical Center 
  • University Medical Center 
  • Medical Center 
  • University Medical Center 
  • Medical Center 
  • Medical Center 
  • University Medical Center 
  • Medical Center 
  • University Medical Center 
  • Medical Center 
  • Medical Center 
  • University Medical Center 
  • University Medical Center 
  • Doctor's Practice 
  • Medical Center 
  • Medical Center 
  • Medical Center 
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Recruitment

  •   Actual
  •   2013/10/02
  •   391
  •   Multicenter trial
  •   International
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Inclusion Criteria

  •   Male
  •   18   Years
  •   no maximum age
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Additional 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

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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

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Addresses

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    • Advanced Medical Diagnostics SAWaterloo Office Park Bât i bte 3
    • Drève Richelle, 161
    • 1410  WATERLOO
    • Belgium
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    • Cliniques Universitaires Saint-Luc Urology Department
    • Mr.  Professor  Bertrand   TOMBAL 
    • Avenue Hippocrate 10
    • 1200  BRUSSELS
    • Belgium
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    • Advanced Medical Diagnostics SA Waterloo Office Park Bât i bte 3
    • Ms.  MSc  Sophie  Danloy 
    • Drève Richelle, 161
    • 1410  WATERLOO
    • Belgium
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Sources of Monetary or Material Support

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    • Advanced Medical Diagnostics sa/nv
    • WOP, Bât.i, Bte3, Drève Richelle 161
    • 1410  Waterloo
    • Belgium
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Status

  •   Recruiting ongoing
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Trial Publications, Results and other Documents

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Additional Trial Attributes

  • Urological disease 
  • If other, please specify 
  • Study recommendations 
  • If other, please specify 
  • German director of clinical investigation 
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    • Urology St. EKH Leipzig
    • Mr.  Dr. med.  Jörg  Rassler 
    • Biedermannstrasse 84
    • 04277  Leipzig
    • Germany
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  • Further contact 
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    • Urology EKH Leipzig
    • Mr.  Dr. med.  Jörg-Uwe  Kempter 
    • Biedermannstrasse 84
    • 04277  Leipzig
    • Germany
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  • Function of contact 
  • Non-interventional study 
  • Stage 
  • If other, please specify 
  • Onset of therapy 
  • If other, please specify 
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* This entry means the parameter is not applicable or has not been set.