Preliminary results of the Spanish Association of Urology National Registry in Active Surveillance for prostate cancer

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• 作者：J. Rubio-Briones<sup>asup><sup> ; sup><sup>jrubio@fivo.org" class="auth_mail" title="E-mail the corresponding authorsup> ; A. Borque<sup>bsup> ; L.M. Esteban<sup>csup> ; I. Iborra<sup>asup> ; P.A. Ló ; pez<sup>dsup> ; J.M. Gil<sup>bsup> ; Y. Pallá ; s<sup>esup> ; Ll. Fumadó ; <sup>fsup> ; S. Martí ; nez-Breijo<sup>gsup> ; V. Chantada<sup>gsup> ; E. Gó ; mez<sup>hsup> ; C. Quicios<sup>isup> ; C.B. Congregado<sup>jsup> ; R. Medina<sup>jsup> ; M. Ortiz<sup>ksup> ; M. Montesino<sup>lsup> ; F. Clar<sup>msup> ; J. Soto<sup>nsup> ; J.M. Campá ; <sup>osup>
• 关键词：Prostate cancer ; Active surveillance ; Multicentre studies ; Prognosis ; Information
• 刊名：Actas Urológicas Espa?olas (English Edition)
• 出版年：2016
• 出版时间：January-February 2016
• 年：2016
• 卷：40
• 期：1
• 页码：3-10
• 全文大小：909 K

文摘

To present a National Registry of patients with prostate cancer as monitored through active surveillance, with the intention of testing the hypothesis that cancer-specific mortality in very low-risk and low-risk patients is less than 5% at 15 years.

sSec_2">Material and methods

spar0010">A multicentre observational study (AEU-PIEM/2014/0001) sponsored by the Spanish Association of Urology was conducted using their platform for multicentre studies. The clinical&ndash;pathological inclusion criteria were as follows: cT1a-cT3a, PSA ≤20 ng/ml, initial minimum biopsy of 10 cores, number of affected cores ≤3, 1st Gleason score of 3 and 2nd Gleason score ≤4 and a known prostate volume (in cm<sup>3sup>). A unified follow-up was not established for all recruiting centers; however, a survey was conducted that reflects the follow-up characteristics based on a number of tangible parameters that allow for their comparison. With the same philosophy of flexibility, the use of certain biomarkers and multiparametric MRI was not considered necessary for inclusion.

sSec_3">Results

spar0015">We describe the Registry's characteristics and possibilities, as well as the preliminary results from the 324 patients included in its first 5 months of operation in the 15 recruiting centers. We also report the clinical&ndash;pathological variables, biomarkers, radiologic techniques and quality-of-life questionnaires considered for the database, as well as the possibilities for indefinite follow-up, remaining open to any active treatment recognized in clinical guidelines.

sSec_4">Conclusions

spar0020">The AEU-PIEM/2014/0001 represents an extremely useful tool for all Spanish urologists for multicentre clinical research. The registry will undoubtedly enable the difussion M&M of active surveillance of our patients in a more coordinated manner, thus maintaining the advantages of optimized opportunistic screening for prostate cancer without resulting in overtreatment.