The primary objective is to compare the sensitivity and specificity of tumour size and growth assessed with HistoScanningTM with the PRIAS parameters (PSA changes). The sensitivity and specificity of both methods will be measured with adverse biopsy…
ID
Source
Brief title
Condition
- Reproductive and genitourinary neoplasms gender unspecified NEC
- Prostatic disorders (excl infections and inflammations)
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The main study endpoint is the area under curve for HistoScanning predicting
adverse repeat biopsy findings.
Secondary outcome
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.
Background summary
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 HistoScanning would be a marker of
disease progression.
Study objective
The primary objective is to compare the sensitivity and specificity of tumour
size and growth assessed with HistoScanningTM 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 Histoscans, 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.
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.
Study burden and risks
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.
's-Gravendijkwal 230
3015 CE Rotterdam
NL
's-Gravendijkwal 230
3015 CE Rotterdam
NL
Listed location countries
Age
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
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| CCMO | NL27765.078.09 |