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

Advanced Medical Diagnostics

Status and phase: Terminated; Phase 4

Conditions: Prostate Cancer

Treatments: Device: Prostate HistoScanning

Study type: Interventional

Funder types: Industry

Identifiers

NCT01950871

CR2P01127

DRKS00005263 (Registry Identifier)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 80 patients

Sex: Male

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Diagnostic

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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80 participants in 1 patient group

single arm study

Other group

Description:

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.

Treatment:

Device: Prostate HistoScanning