Computer-aided ultrasound (HistoScanning) in men with prostate cancer on active surveillance.
Recruiting
- Conditions
- prostate cancer, active surveillance, computer-aided ultrasonography, HistoScanning.prostaat kanker, actief afwachtend beleid, computerondersteunde echoscopie, HistoScanning.
- Registration Number
- NL-OMON21941
- Lead Sponsor
- Drs. S. van den Heuvel
- Brief Summary
/A
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- Not specified
- Target Recruitment
- 150
Inclusion Criteria
1. Male patient aged ≥ 18 years;
2. Newly diagnosed patients participating in the PRIAS-study or patients participating for 3 years;
Exclusion Criteria
1. Incapable of understanding the language in which the information for the patient is given;
2. Patient who can not or does not want to be radiated or operated;
Study & Design
- Study Type
- Observational non invasive
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method The main study endpoint is the area under the curve for HistoScanning predicting adverse repeat biopsy findings.
- Secondary Outcome Measures
Name Time Method 1. Time to deferred active treatment while on active surveillance;<br /><br>2. Kappa-coefficient for interobserver variability.