prostate cancer, active surveillance, computer-aided ultrasonography, HistoScanning. prostaat kanker, actief afwachtend beleid, computerondersteunde echoscopie, HistoScanning.
Conditions
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 pr
Sponsors
Drs. S. van den Heuvel
Eligibility
Inclusion criteria
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
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The main study endpoint is the area under the curve for HistoScanning predicting adverse repeat biopsy findings. | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Time to deferred active treatment while on active surveillance; 2. Kappa-coefficient for interobserver variability. | — |
Contacts
Public ContactS. Heuvel, van den
ErasmusMC Room H-187 's Gravendijkwal 230
Outcome results
None listed