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

Recruiting

• Conditions: Prostate cancer, overdiagnosis, overtreatment, active surveillance

• Registration Number: NL-OMON22061
• Lead Sponsor: Erasmus MC, Rotterdam.

Brief Summary

Prospective validation of active surveillance in prostate cancer: the PRIAS study.<br> 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>

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 28 February 2024

Recruitment & Eligibility

• Status: Recruiting
• Sex: Not specified
• Target Recruitment: 2000

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.

Study & Design

• Study Type: Observational non invasive
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Treatment free survival.

Secondary Outcome Measures

Name	Time	Method
Prostate cancer specific and overall mortality.