|- candidate number||6346|
|- NTR Number||NTR1968|
|- ISRCTN||ISRCTN wordt niet meer aangevraagd.|
|- Date ISRCTN created|
|- date ISRCTN requested|
|- Date Registered NTR||24-aug-2009|
|- Secondary IDs||MEC-2009-185 METC Erasmus MC|
|- Public Title||Computer-aided ultrasound (HistoScanning) in men with prostate cancer on active surveillance.|
|- Scientific Title||Computer-aided ultrasonography (HistoScanning) in men with untreated localised prostate cancer on active surveillance.|
|- hypothesis||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.|
|- Healt Condition(s) or Problem(s) studied||Prostatic neoplasms, Active surveillance, Computer-aided ultrasonography, HistoScanning|
|- Inclusion criteria||1. Male patient aged ≥ 18 years;|
2. Newly diagnosed patients participating in the PRIAS-study or patients participating for 3 years;
3. The PRIAS-study has the following inclusion criteria:
A. Histologically proven adenocarcinoma of the prostate;
B. Patient should be fit for curative treatment;
C. PSA-level at diagnosis ≤ 10 ng/mL;
D. PSA density (PSA D) less than 0,2;
E. Clinical stage T1C or T2;
F. Appropriate biopsy sampling (see 12.4 Appendix D table 1);
G. Gleason score 3+3=6 or less;
H. One or 2 biopsy cores invaded with prostate cancer;
I. Participants must be willing to attend the follow-up visits;
J. Provides written Informed Consent and is willing and able to comply with protocol requirements.
|- 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;
3. Previously treated for prostate cancer.
|- mec approval received||yes|
|- multicenter trial||yes|
|- Type||Single arm|
|- planned startdate ||14-sep-2009|
|- planned closingdate|
|- Target number of participants||150|
|- Interventions||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.|
|- Primary outcome||The main study endpoint is the area under the curve for HistoScanning predicting adverse repeat biopsy findings. |
|- Secondary outcome||1. Time to deferred active treatment while on active surveillance;|
2. Kappa-coefficient for interobserver variability.
|- Timepoints||2 years.|
|- Trial web site||N/A|
|- status||open: patient inclusion|
|- CONTACT FOR PUBLIC QUERIES||Drs. S. Heuvel, van den|
|- CONTACT for SCIENTIFIC QUERIES||Drs. S. Heuvel, van den|
|- Sponsor/Initiator ||Erasmus Medical Center, Department of Urology|
(Source(s) of Monetary or Material Support)
|Erasmus Medical Center, Department of Urology|
|- Brief summary||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.
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.
Prospective multicentre observational study.
Patients with histologically proven adenocarcinoma of the prostate gland, managed by active surveillance and participating in the PRIAS-study.
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 patientís 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.
|- Main changes (audit trail)|
|- RECORD||24-aug-2009 - 12-okt-2009|