No registrations found.
ID
Source
Brief title
Health condition
Prostate cancer, overdiagnosis, overtreatment, active surveillance
Sponsors and support
Intervention
Outcome measures
Primary outcome
Treatment free survival.
Secondary outcome
Prostate cancer specific and overall mortality.
Background 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.
Study objective
Early prostate cancer may safely be managed with an active surveillance strategy, avoiding overtreatment and the risk of resulting side effects.
Study design
Yearly analyses are being performed.
Intervention
None, observational study.
P.O. Box 2040
Monique Roobol-Bouts
Wytemaweg 80, kamer Na-1520
Rotterdam 3000 CN
The Netherlands
+ 31 (0)10 70 322 42
m.roobol@erasmusmc.nl
P.O. Box 2040
Monique Roobol-Bouts
Wytemaweg 80, kamer Na-1520
Rotterdam 3000 CN
The Netherlands
+ 31 (0)10 70 322 42
m.roobol@erasmusmc.nl
Inclusion criteria
1) Histologically proven adenocarcinoma of the prostate.
2) Men should be fit for curative treatment.
3) PSA-level at diagnosis ≤ 10 ng/mL.
4) PSA density (PSA D) less than 0.2.
5) Clinical stage T1C or T2.
6) Gleason score 3+3=6.
7) One or 2 biopsy cores invaded with prostate cancer:
a.
If an MRI, including targeted biopsies on positive lesions, is done at inclusion, there is no limit in the number of positive cores (that is, more than two, and no limit in the % of cancer present in the cores).
b.
If saturation biopsies (either transperineal or transrectal) are done 15% of the cores can be positive with a maximum of 4. (i.e. <20 cores 2 cores can be positive (standard), 20-26 cores 3 cores can be positive, >26 cores 4 cores can be positive) (all other inclusion criteria still apply).
8) Participants must be willing to attend the follow-up visits.
Note: Patients with biopsy Gleason score 3+4 can be followed outside the actual PRIAS protocol.
The patient should be at least 70 years old and should have evidence of limited disease (maximum 10% tumor involvement per biopsy core, maximum 2 cores positive).
Risk reclassification is defined as any upgrading in Gleason score and/or more than 2 positive cores at repeat biopsy.
Exclusion criteria
1) Men who can not or do not want to be radiated or operated.
2) A former therapy for prostate cancer.
Design
Recruitment
IPD sharing statement
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 |
|---|---|
| NTR-new | NL1622 |
| NTR-old | NTR1718 |
| Other | MEC ErasmusMC : 2004-339 |
| ISRCTN | ISRCTN wordt niet meer aangevraagd |
Summary results
van den Bergh RCN, Roemeling S, Roobol MJ, Roobol W, Schröder FH, Bangma CH.<br>
Eur Urol. 2007 Dec;52(6):1560-3. PMID: 17532115.
<br><br>
The Prostate cancer Research International: Active Surveillance study.<br>
Bangma CH, Bul M, Roobol M.<br>
Curr Opin Urol. 2012 May;22(3):216-21. doi: <br>10.1097/MOU.0b013e328351dcc7. Review.<br>
PMID:22453333
<br><br>
Active surveillance for low-risk prostate cancer worldwide: the PRIAS study.<br>
Bul M, Zhu X, Valdagni R, Pickles T, Kakehi Y, Rannikko A, Bjartell A, van der Schoot DK, Cornel EB, Conti GN, Boevé ER, Staerman F, Vis-Maters JJ, Vergunst H, Jaspars JJ, Strölin P, van Muilekom E, Schröder FH, Bangma CH, Roobol MJ.<br>
Eur Urol. 2013 Apr;63(4):597-603. doi: <br>10.1016/j.eururo.2012.11.005. Epub 2012 Nov 12.
PMID:23159452<br><br>
A Decade of Active Surveillance in the PRIAS Study: An Update and Evaluation of the Criteria Used to Recommend a Switch to Active Treatment.<br>
Bokhorst LP, Valdagni R, Rannikko A, Kakehi Y, Pickles T, Bangma CH, Roobol MJ; PRIAS study group..<br>
Eur Urol. 2016 Dec;70(6):954-960. doi: <br>10.1016/j.eururo.2016.06.007. Epub 2016 Jun 19.
PMID:27329565<br><br>
Complications after prostate biopsies in men on active surveillance and its effects on receiving further biopsies in the Prostate cancer Research International: Active Surveillance (PRIAS) study.<br>
Bokhorst LP, Lepistö I, Kakehi Y, Bangma CH, Pickles T, Valdagni R, Alberts AR, Semjonow A, Strölin P, Montesino MF, Berge V, Roobol MJ, Rannikko A.<br>
BJU Int. 2016 Sep;118(3):366-71. doi: 10.1111/bju.13410. Epub 2016 Feb 12.<br>
PMID:26765682<br><br>
Compliance Rates with the Prostate Cancer Research International Active Surveillance (PRIAS) Protocol and Disease Reclassification in Noncompliers.<br>
Bokhorst LP, Alberts AR, Rannikko A, Valdagni R, Pickles T, Kakehi Y, Bangma CH, Roobol MJ; PRIAS study group..<br>
Eur Urol. 2015 Nov;68(5):814-21. doi: 10.1016/j.eururo.2015.06.012. Epub 2015 Jun 29.<br>
PMID:26138043<br><br>