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van CCT (UK)


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van CCT (UK)


'PRIAS: Prostate cancer Research International: Active Surveillance - guideline and study for the expectant management of localized prostate cancer with curative intent'.


- candidate number5440
- NTR NumberNTR1718
- ISRCTNISRCTN wordt niet meer aangevraagd
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR11-mrt-2009
- Secondary IDs2004-339 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'.
- ACRONYMRCNvdB
- hypothesisEarly 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) studiedProstate cancer
- Inclusion criteria1. 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 criteriaDuring 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 receivedyes
- multicenter trialyes
- randomisedno
- groupParallel
- TypeSingle arm
- Studytypeobservational
- planned startdate 1-dec-2006
- planned closingdate1-dec-2021
- Target number of participants2000
- InterventionsNone, observational study.
- Primary outcomeTreatment free survival.
- Secondary outcomeProstate cancer specific and overall mortality.
- TimepointsYearly analyses are being performed.
- Trial web sitewww.prias-project.org
- statusopen: patient inclusion
- CONTACT FOR PUBLIC QUERIESMD Roderick Bergh, van den
- CONTACT for SCIENTIFIC QUERIESMD Roderick Bergh, van den
- Sponsor/Initiator Erasmus Medical Center
- Funding
(Source(s) of Monetary or Material Support)
Prostate Cancer Research Foundation (SWOP) Rotterdam, The Netherlands
- PublicationsProspective 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 summaryThe 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)
- RECORD11-mrt-2009 - 14-sep-2009


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