'PRIAS: Prostate cancer Research International: Active Surveillance - guideline and study for the expectant management of localized prostate cancer with curative intent'.
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 2,000
研究概览
简要总结
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.
The Prostate cancer Research International: Active Surveillance study.
Bangma CH, Bul M, Roobol M.
Curr Opin Urol. 2012 May;22(3):216-21. doi:
10.1097/MOU.0b013e328351dcc7. Review.
PMID:22453333
Active surveillance for low-risk prostate cancer worldwide: the PRIAS study.
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.
Eur Urol. 2013 Apr;63(4):597-603. doi:
10.1016/j.eururo.2012.11.005. Epub 2012 Nov 12. PMID:23159452
A Decade of Active Surveillance in the PRIAS Study: An Update and Evaluation of the Criteria Used to Recommend a Switch to Active Treatment.
Bokhorst LP, Valdagni R, Rannikko A, Kakehi Y, Pickles T, Bangma CH, Roobol MJ; PRIAS study group..
Eur Urol. 2016 Dec;70(6):954-960. doi:
10.1016/j.eururo.2016.06.007. Epub 2016 Jun 19. PMID:27329565
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.
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.
BJU Int. 2016 Sep;118(3):366-71. doi: 10.1111/bju.13410. Epub 2016 Feb 12.
PMID:26765682
Compliance Rates with the Prostate Cancer Research International Active Surveillance (PRIAS) Protocol and Disease Reclassification in Noncompliers.
Bokhorst LP, Alberts AR, Rannikko A, Valdagni R, Pickles T, Kakehi Y, Bangma CH, Roobol MJ; PRIAS study group..
Eur Urol. 2015 Nov;68(5):814-21. doi: 10.1016/j.eururo.2015.06.012. Epub 2015 Jun 29.
PMID:26138043
研究设计
- 研究类型
- Observational
入排标准
入选标准
- •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:
- •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).
- •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.
排除标准
- •1) Men who can not or do not want to be radiated or operated.
- •2) A former therapy for prostate cancer.