Computer-aided ultrasound (HistoScanning) in men with prostate cancer on active surveillance.

Rationale:
Markers that predict the behaviour of localized prostate cancer are needed to identify patients who require treatment. We hypothesise that, within the group of low-risk disease (as identified by the PRIAS protocol), the initial tumour volume and tumour growth assessed with HistoScanningTM would be a marker of disease progression.

Objective:
The primary objective is to compare the sensitivity and specificity of tumour size and growth assessed with HistoScanning with the PRIAS parameters (PSA changes). The sensitivity and specificity of both methods will be measured with adverse biopsy findings as golden standard.

Secondary objectives are to assess the correlation of HistoScanning results and time to deferred treatment, if HistoScanning-targeted biopsies improve the yield of positive tumour biopsies, interuser and interobserver variability, reproducibility of subsequent HistoScannings, ease of use in clinical practice and the correlation of HistoScanning with pathological findings of prostate biopsies and radical prostatectomy specimens.

Study design:
Prospective multicentre observational study.

Study population:
Patients with histologically proven adenocarcinoma of the prostate gland, managed by active surveillance and participating in the PRIAS-study.

Intervention:
Patients will visit the outpatient clinic for a transrectal computer-aided ultrasonography (HistoScanning) at 0, 3, 6, 12, 18 and 24 months. At 12 months patients will also receive two HistoScanning guided biopsies simultaneously with the scheduled systematic biopsies within the PRIAS study.

Main study parameter/endpoint:
The main study endpoint is the area under the curve for HistoScanning predicting adverse repeat biopsy findings.

Nature and extent of the burden and risks associated with participation, benefit and group relatedness:
The visits for HistoScanning can be combined with the visits for the PRIAS-study. The HistoScanning should, from the patient’s perspective, be no different to a standard diagnostic transrectal ultrasonography. The benefit for the patient could be a more accurate biopsy sampling and therefore in case of a progressive cancer an earlier discovery.

We hypothesise that, within the group of low-risk disease the initial tumour volume and tumour growth assessed with HistoScanning would be a marker of disease progression.

2 years.

Computer-aided ultrasound (HistoScanning) of the prostate at inclusion and after 3, 6, 12, 18 and 24 months. At 12 months also 2 HistoScanning guided prostate biopsies in addition to the systematic prostate biopsies scheduled in the standard care.