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

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ClinicalTrials.gov Identifier: NCT01950871
Recruitment Status : Terminated (Sponsor is bankrupt)
First Posted : September 26, 2013
Last Update Posted : January 5, 2015
Sponsor:
Information provided by (Responsible Party):
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.


Condition or disease Intervention/treatment Phase
Prostate Cancer Device: Prostate HistoScanning Phase 4

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 80 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Diagnostic Performance of Prostate HistoScanningTM (PHS) in Men at Risk of Prostate Cancer Scheduled for an Initial Prostate Biopsy
Study Start Date : October 2013
Actual Primary Completion Date : July 2014
Actual Study Completion Date : July 2014

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
single arm study
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.
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.
Other Name: PHS/PHS TT




Primary Outcome Measures :
  1. Diagnostic performance of prostate HistoScanning (HS) to identify clinically significant PCa using histology outcomes from systematic prostate biopsy (Bx) as reference [ Time Frame: 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 :
  1. Diagnostic performance of prostate HS to identify PCa using histology outcomes from systematic Bx as reference [ Time Frame: 1 year ]
    Compare prostate HS results to the systematic Bx outcome (positive or negative) for all PCa in the non-run-in population.

  2. 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 [ Time Frame: 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.

  3. Difference in detection rates of clinically significant PCa between systematic and HS-guided biopsy. [ Time Frame: 1 year ]
    Compared PCa detection rates of systematic and HS-guided prostate Bx in the non-run-in population.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01950871


Locations
Show Show 34 study locations
Sponsors and Collaborators
Advanced Medical Diagnostics s.a.
Investigators
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Principal Investigator: Bertrand Tombal, Prof Cliniques Universitaires Saint-Luc, Brussels, Belgium

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Responsible Party: Advanced Medical Diagnostics s.a.
ClinicalTrials.gov Identifier: NCT01950871    
Other Study ID Numbers: CR2P01127
DRKS00005263 ( Registry Identifier: Deutsches Register Klinischer Studien )
First Posted: September 26, 2013    Key Record Dates
Last Update Posted: January 5, 2015
Last Verified: January 2015
Keywords provided by Advanced Medical Diagnostics s.a.:
HistoScanning
TRUS
Prostate cancer
Biopsy guidance
Additional relevant MeSH terms:
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Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Genital Diseases, Male
Prostatic Diseases