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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 %.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Registry | Other | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Cancer specific survival in patients in active surveillance | Global CSS will be recorded, independently of each Center protocol, from enrollment to death due to PRostate Cancer Estimated CSS will be analyzed at 5, 10 and 15 years from initiation of the protocol. To this purpose, patients will be followed although they progressed and went into active treatment. | up to 15 years |
| Overall survival | Global OS will be recorded, independently of each Center protocol, from enrollment to death of any cause Estimated OS will be analyzed at 5, 10 and 15 years from initiation of the protocol To this purpose, patients will be followed although they progressed and went into active treatment or if the kept in active surveillance till their death due to any cause. | Date randomization-date death, or up to 15 years, whichever came first |
| Active treatment-free interval | Time to active treatment will be recorded, independently of each Center protocol, from enrollment to any other active due to prostate cancer progression or patient desire to receive any active treatment Estimated active treatment free survival will be analyzed at 2, 5 and 10 years from initiation of the protocol. | 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 | Characterization of pathologically agressive tumours will be done by analyzing the pathological reports of radical prostatectomy specimens derived from patients included in the protocol that went on to radical prostatectomy. This has no time frame, although time of radical prostatectomy will be a variable to take in account for comparisions among different timings of performace of radical prostatectomies. | From the study start and stop until 15 years |
| Characterization of pathologically agressive tumors by TNM |
| Measure | Description | Time Frame |
|---|---|---|
| Quality of Life in patients with active surveillance | Assessed with CAVIPRESS-30 questionaires | up to 5 years |
| Quality of Life in patients with active surveillance | Assessed with EPIC-20 questionaires |
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Inclusion Criteria:
Exclusion Criteria:
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Spain male residents diagnosed with low risk PCa (NCCN)
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Jose Rubio Briones, MD, PhD | Contact | jrubio@fivo.org | ||
| Ángel Borque Fernando, MD, PhD | Contact | aborque@comz.org |
| Name | Affiliation | Role |
|---|---|---|
| Jose Rubio Briones, MD, PhD | IVO | Principal Investigator |
| Ángel Borque Fernando, MD, PhD | Hospital Miguel Servet | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Instituto Valenciano de Oncología | Recruiting | Valencia | 46009 | Spain |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 26115777 | Background | 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.2015.05.006. Epub 2015 Jun 23. English, Spanish. | |
| 29312542 |
| Label | URL |
|---|---|
| Enlace a la página web de la asociación Española de Urología | View source |
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| ID | Term |
|---|---|
| D011471 | Prostatic Neoplasms |
| ID | Term |
|---|---|
| D005834 | Genital Neoplasms, Male |
| D014565 | Urogenital Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
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| ID | Term |
|---|---|
| D012042 | Registries |
| ID | Term |
|---|---|
| D003625 | Data Collection |
| D004812 | Epidemiologic Methods |
| D008919 | Investigative Techniques |
| D011996 | Records |
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7.5 ml of blood sample Biopsy sample
Characterization of pathologically agressive tumours will be done by analyzing the pathological reports of radical prostatectomy specimens derived from patients included in the protocol that went on to radical prostatectomy. This has no time frame, although time of radical prostatectomy will be a variable to take in account for comparisions among different timings of performace of radical prostatectomies. |
| From the study start and stop until 15 years |
| up to 5 years |
| Background |
| 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 Registry. Oncotarget. 2017 Oct 24;8(65):108451-108462. doi: 10.18632/oncotarget.21984. eCollection 2017 Dec 12. |
| 40926355 | Derived | 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 Barreras S, Pallas Costa Y, Vilaseca Cabo A, Rodrigo Aliaga M, Campanario Perez F, Servian P, Campa Bortolo JM, Soto Delgado M, Rodriguez de Ledesma JM, Sanchez Rodriguez C, Chantada Abal V, Hernandez Martinez YE, Herrera Imbroda B, Dolezal P, Gual Frau J, Medrano Llorente P, Moreno Jimenez J, Serrano Uribe JS, Congregado Ruiz CB, Reyes A, Fernandez Aparicio T, Garcia Rodriguez J, Cuadras Sole M, Garcia Segui A, Pacheco Bru JJ, Mayor de Castro J, Mira Moreno A, Molina Suarez JL. Real World Evidence of Active Surveillance for Prostate Cancer in Spain; Midterm Results. Cancer Med. 2025 Sep;14(17):e71173. doi: 10.1002/cam4.71173. |
| 30108375 | Derived | 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 reclassification in prostate cancer active surveillance. Prostate Cancer Prostatic Dis. 2019 Mar;22(1):84-90. doi: 10.1038/s41391-018-0074-5. Epub 2018 Aug 14. |
| D005832 |
| Genital Diseases, Male |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D011469 | Prostatic Diseases |
| D052801 | Male Urogenital Diseases |
| D009934 |
| Organization and Administration |
| D006298 | Health Services Administration |
| D017531 | Health Care Evaluation Mechanisms |
| D011787 | Quality of Health Care |
| D017530 | Health Care Quality, Access, and Evaluation |
| D011634 | Public Health |
| D004778 | Environment and Public Health |