Prostate Guided Biopsy Study Evaluating the Diagnostic Performance of Prostate HistoScanning

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

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

Conditions
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Prostate Cancer

Intervention / Treatment
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* Device: Prostate HistoScanning


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: single arm study<br>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<br>* 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.<br>* Other names: PHS/PHS TT;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Diagnostic performance of prostate HistoScanning (HS) to identify clinically significant PCa using histology outcomes from systematic prostate biopsy (Bx) as reference | 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. | 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Diagnostic performance of prostate HS to identify PCa using histology outcomes from systematic Bx as reference | Compare prostate HS results to the systematic Bx outcome (positive or negative) for all PCa in the non-run-in population. | 1 year | 
| 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 | 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. | 1 year | 
| Difference in detection rates of clinically significant PCa between systematic and HS-guided biopsy. | Compared PCa detection rates of systematic and HS-guided prostate Bx in the non-run-in population. | 1 year | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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HistoScanning, TRUS, Prostate cancer, Biopsy guidance