|- candidate number||5440|
|- NTR Number||NTR1718|
|- ISRCTN||ISRCTN wordt niet meer aangevraagd|
|- Date ISRCTN created|
|- date ISRCTN requested|
|- Date Registered NTR||11-mrt-2009|
|- Secondary IDs||2004-339 MEC ErasmusMC |
|- Public Title||'PRIAS: Prostate cancer Research International: Active Surveillance - guideline and study for the expectant management of localized prostate cancer with curative intent'.
|- Scientific Title||'PRIAS: Prostate cancer Research International: Active Surveillance - guideline and study for the expectant management of localized prostate cancer with curative intent'.
|- hypothesis||Early prostate cancer may safely be managed with an active surveillance strategy, avoiding overtreatment and the risk of resulting side effects.|
|- Healt Condition(s) or Problem(s) studied||Prostate cancer|
|- Inclusion criteria||1. Provene adenomcarcinoma of the prostate;|
2. CLinical stage T1C/T2;
3. Prostate specific antigen =<10.0 ng/ml;
4. PSA density <0.2;
5. 1-2 positive prostate biopsies;
6. Gleason score 3+3=6 or more favorable.
|- Exclusion criteria||During follow-up:|
1. PSA doubling time <3 years;
2. Clinical stage >T2;
3. >2 positive prostate biopsies;
4. Gleason score >3+3=6.
|- mec approval received||yes|
|- multicenter trial||yes|
|- Type||Single arm|
|- planned startdate ||1-dec-2006|
|- planned closingdate||1-dec-2021|
|- Target number of participants||2000|
|- Interventions||None, observational study.|
|- Primary outcome||Treatment free survival.|
|- Secondary outcome||Prostate cancer specific and overall mortality.|
|- Timepoints||Yearly analyses are being performed.|
|- Trial web site||www.prias-project.org|
|- status||open: patient inclusion|
|- CONTACT FOR PUBLIC QUERIES||MD Roderick Bergh, van den |
|- CONTACT for SCIENTIFIC QUERIES||MD Roderick Bergh, van den |
|- Sponsor/Initiator ||Erasmus Medical Center|
(Source(s) of Monetary or Material Support)
|Prostate Cancer Research Foundation (SWOP) Rotterdam, The Netherlands|
|- Publications||Prospective validation of active surveillance in prostate cancer: the PRIAS study.
van den Bergh RCN, Roemeling S, Roobol MJ, Roobol W, Schröder FH, Bangma CH.
Eur Urol. 2007 Dec;52(6):1560-3. PMID: 17532115.
|- Brief summary||The incidence of prostate cancer has been rising over the last two decades, while the absolute mortality has remained stable. The proportion of men dying WITH prostate cancer instead of FROM prostate cancer has therefore increased.
A so called active surveillance strategy of selecting prostate tumors with a favorable prognosis, withholding radical treatment but instead monitoring the tumor with the option of curative treatment at the moment of progression, is indicated in a large proportion of the newly diagnosed prostate cancer.
Our international, protocol based, observational study aims to prospectively collect evidence for this stratregy, by applying a strcit protocl of inclusion and followcriteria.|
|- Main changes (audit trail)|
|- RECORD||11-mrt-2009 - 14-sep-2009|