Prostate Guided Biopsy Study Evaluating the Diagnostic Performance of Prostate HistoScanning
Prostate Guided Biopsy Study Evaluating the Diagnostic Performance of Prostate HistoScanning
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.
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.
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