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Prostate Guided Biopsy Study Evaluating the Diagnostic Performance of Prostate HistoScanning

NCT01950871 · Status: TERMINATED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 80

Last updated 2015-01-05

No results posted yet for this study

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.

Conditions

Interventions

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.

Sponsors & Collaborators

  • Advanced Medical Diagnostics s.a.

    lead INDUSTRY

Principal Investigators

  • Bertrand Tombal, Prof · Cliniques Universitaires Saint-Luc, Brussels, Belgium

Study Design

Allocation
NA
Purpose
DIAGNOSTIC
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
MALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2013-10-31
Primary Completion
2014-07-31
Completion
2014-07-31

Countries

  • Austria
  • Belgium
  • Bulgaria
  • Czechia
  • Denmark
  • Estonia
  • France
  • Germany
  • Hungary
  • Italy
  • Latvia
  • Lithuania
  • Netherlands
  • Russia
  • Spain
  • Switzerland
  • Turkey (Türkiye)
  • United Kingdom

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01950871 on ClinicalTrials.gov