Computer-aided ultrasonography (HistoScanning) in men with untreated localised prostate cancer on active surveillance.

Completed

• Conditions: 10036958; Prostate cancer; prostate carcinoma; 10038588

• Registration Number: NL-OMON33297
• Lead Sponsor: Erasmus MC, Universitair Medisch Centrum Rotterdam

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 6 May 2024

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 115

Inclusion Criteria

• Male patient aged >= 18 years.
• Newly diagnosed patients participating in PRIAS or patients participating for 3 years.
• PRIAS has the following inclusion criteria:
o Histologically proven adenocarcinoma of the prostate
o Patient should be fit for curative treatment
o PSA-level at diagnosis <= 10 ng/mL
o PSA density (PSA D) less than 0,2
o Clinical stage T1C or T2
o Appropriate biopsy sampling
o Gleason score 3+3=6 (or less)
o One or 2 biopsy cores invaded with prostate cancer
o Participants must be willing to attend the follow-up visits
• Provides written Informed Consent and is willing and able to comply with protocol requirements.

Exclusion Criteria

• Incapable of understanding the language in which the information for the patient is given.
• Patient who can not or do not want to be radiated or operated
• Previously treated for prostate cancer

Study & Design

• Study Type: Observational invasive
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>The main study endpoint is the area under curve for HistoScanning predicting<br /><br>adverse repeat biopsy findings.</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>Time to deferred active treatment, number of positive biopsy cores (systematic<br /><br>and HistoScanning guided), percentage of corresponding quadrants defined by<br /><br>HistoScanning and biopsy, percentage of corresponding quadrants defined by<br /><br>HistoScanning and radical prostatectomy, Kappa coefficient, percentage of<br /><br>corresponding quadrants defined by various HistoScanning procedures,<br /><br>qualitative description of physician questionnaire, number of successful<br /><br>HistoScannings.<br /><br><br /><br>Baseline values are age, initial PSA level, clinical tumour stage, free PSA to<br /><br>total PSA ratio, PSA velocity, Gleason score, prostate volume, PSA density and<br /><br>PSA doubling time.</p><br>