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

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

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

NL-OMON

Registry ID

NL-OMON33297

Enrollment

115

Registered

2009-08-13

Start date

2009-09-30

Completion date

Unknown

Last updated

2024-05-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Prostate cancer prostate carcinoma

Interventions

None listed

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

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

Exclusion criteria

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

Design outcomes

Primary

Measure	Time frame
The main study endpoint is the area under curve for HistoScanning predicting adverse repeat biopsy findings.	—

Secondary

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

Measure

Time frame

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

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Countries

Netherlands

Outcome results