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

Prostate Cancer Clinical Trial

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

Status Terminated

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.

Clinical Trial 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. ;

Study Design

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

Related Conditions & MeSH terms

• Prostate Cancer
• Prostatic Neoplasms

• NCT number: NCT01950871
• Study type: Interventional
• Source: Advanced Medical Diagnostics s.a.
• Status: Terminated
• Phase: Phase 4
• Start date: October 2013
• Completion date: July 2014