Spanish Urological Association Registry of Patients on Active Surveillance

Overview

Description: Multicentre observational study, not randomized. Ambispective character (retro and prospective). Opened to any member of the Asociación Española de Urología (AEU), public and private medicine. Justification: Active surveillance is a strategy proposed to control the overtreatment derived from the opportunist screening in prostate cancer (PCa). Its development in our country is erratic and different in every Center. This database tries to include most of patients included in active surveillance in Spain with a few minimal inclusion criteria. Multicentre registry and follow up of the active surveillance in Spain. Hypothesis: Mortality cancer specific for PCa includible in active surveillance to 15 years is lower than 5 %.

Interventions

• Other Registry
  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.

Primary outcome measures

• Cancer specific survival in patients in active surveillance [Time frame: up to 15 years]
• Overall survival [Time frame: Date randomization-date death, or up to 15 years, whichever came first]
• Active treatment-free interval [Time frame: Date start active surveillance-stop active surveillance due to active treatment, or up to 15 years, whichever came first]
• Characterization of pathologically agressive tumors by Gleason score [Time frame: From the study start and stop until 15 years]
• Characterization of pathologically agressive tumors by TNM [Time frame: From the study start and stop until 15 years]

Secondary outcome measures (2)

• Quality of Life in patients with active surveillance [Time frame: up to 5 years]
• Quality of Life in patients with active surveillance [Time frame: up to 5 years]

Eligibility criteria

Inclusion criteria

• PSA ≤ 10 ng / mL; if prostate volume> 60 cc in transrectal, ultrasound includable with PSA>10 ng / ml if PSAD <0.20
• Local Stadium DRE; cT1c -cT2a
• Diagnosis of transrectal ultrasound guided biopsy minimum 10 cylinders
• Adenocarcinoma Prostate Gleason ≤ 6 (3 + 3) with local and central pathology review
• Maximum number of cylinders = 2 and none of them more than 5mm tumor or more than 50% of assignment
• <80 years and greater expectancy to 10 years life (Charlson score)
• Patients able to understand active surveillance and sign the Informed Consent

Exclusion criteria

• Patient not be able to accept up with repeat biopsies
• Patient who does not want to sign the Informed Consent
• Hospital where the possibility of a biopsy confirmation at 6 months is not guaranteed under the terms of the inclusion criteria
• Patients with a history of ASAP (atypical small acinar proliferation or atypical microglands)
• Patients with treatment with inhibitors of 5-alpha-reductase as dutasteride (Avidart®) and finasteride (Proscar®) during the previous six months
• Patients who have undergone during the 6 months prior to any treatment symptomatic benign prostate hyperplasia, or any invasive urological procedure. It can be associated with an increase of PSA prior to phlebotomy. These therapies include, but they are not limited to, prostate biopsy, thermotherapy, microwave therapy, laser, urethral resection of the prostate, urethral catheterization and the lower genitourinary tract endoscopy.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model

Cohort

Study locations

Spain · 1 center

• Instituto Valenciano de Oncología — Valencia

Publications

• Rubio-Briones J, Borque A, Esteban LM, Iborra I, Lopez PA, Gil JM, Pallas Y, Fumado L, Martinez-Breijo S, Chantada V, Gomez E, Quicios C, Congregado CB, Medina R, Ortiz M, Montesino M, Clar F, Soto J, Campa JM. Preliminary results of the Spanish Association of Urology National Registry in Active Surveillance for prostate cancer. Actas Urol Esp. 2016 Jan-Feb;40(1):3-10. doi: 10.1016/j.acuro.2015.05 PMID 26115777
• Borque-Fernando A, Rubio-Briones J, Esteban LM, Collado-Serra A, Pallas-Costa Y, Lopez-Gonzalez PA, Huguet-Perez J, Sanz-Velez JI, Gil-Fabra JM, Gomez-Gomez E, Quicios-Dorado C, Fumado L, Martinez-Breijo S, Soto-Villalba J. The management of active surveillance in prostate cancer: validation of the Canary Prostate Active Surveillance Study risk calculator with the Spanish Urological Association Re PMID 29312542
• Rubio-Briones J, Borque-Fernando A, Esteban Escano LM, Wong A, Guijarro Cascales A, Gomez Gomez E, Gil Fabra JM, Sanguedolce F, Gomez-Veiga F, Lopez Gonzalez PA, Plata Bello A, Rodriguez Garcia N, Montesino Semper M, Suarez Novo JF, Hajianfar R, Fumado Ciutat LL, Gonzalez Alfaro A, Duarte Ojeda JM, Bono Arino A, Quicios Dorado C, Loizaga Iriarte A, Garcia Fadrique G, Gimenez Bachs JM, Garcia Barre PMID 40926355
• Borque-Fernando A, Rubio-Briones J, Esteban LM, Dong Y, Calatrava A, Gomez-Ferrer A, Gomez-Gomez E, Gil Fabra JM, Rodriguez-Garcia N, Lopez Gonzalez PA, Garcia-Rodriguez J, Rodrigo-Aliaga M, Herrera-Imbroda B, Soto-Villalba J, Martinez-Breijo S, Hernandez-Canas V, Soto-Poveda AM, Sanchez-Rodriguez C, Carrillo-George C, Hernandez-Martinez YE, Okrongly D. Role of the 4Kscore test as a predictor of r PMID 30108375

Identifiers

NCT: NCT02865330 · AEU-PIEM/2014/0001

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗