Spanish Urological Association Registry of Patients on Active Surveillance

NCT02865330 | Recruiting

• 1 other identifier: AEU-PIEM/2014/0001
• Study Type: observational
• Target: 946
• Locations: 1 country
• Sites: 1

Brief Summary

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 %.

Conditions

Prostate Cancer

Keywords

Intermediate Risk Prostate Cancer; Low Risk Prostate Cancer; Active Surveillance

Outcome Measures

Primary Outcomes (5)

• 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

  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

Secondary Outcomes (2)

• Quality of Life in patients with active surveillance

  up to 5 years

• Quality of Life in patients with active surveillance

  up to 5 years

Interventions

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.

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Spain male residents diagnosed with low risk PCa (NCCN)

You may qualify if:

• 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

You may not qualify if:

• Patient not be able to accept up with repeat biopsies
• Patient who does not want to sign the Informed Consent
• 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.

Sponsors & Collaborators

• Fundación Instituto Valenciano de Oncología: lead

Study Sites (1)

Instituto Valenciano de Oncología

Valencia, 46009, Spain

RECRUITING

Related Publications (4)

• 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.

  PMID: 26115777 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.

  PMID: 29312542 BACKGROUND

• 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.

  PMID: 40926355 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.

  PMID: 30108375 DERIVED

Related Links

• Enlace a la página web de la asociación Española de Urología

Biospecimen

Retention: NONE RETAINED

7.5 ml of blood sample Biopsy sample

MeSH Terms

Conditions

Prostatic Neoplasms

Interventions

Registries

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases

Intervention Hierarchy (Ancestors)

Data Collection; Epidemiologic Methods; Investigative Techniques; Records; Organization and Administration; Health Services Administration; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Public Health; Environment and Public Health

Study Officials

• Jose Rubio Briones, MD, PhD

  IVO

  PRINCIPAL INVESTIGATOR

• Ángel Borque Fernando, MD, PhD

  Hospital Miguel Servet

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jose Rubio Briones, MD, PhD

CONTACT

jrubio@fivo.org

Ángel Borque Fernando, MD, PhD

CONTACT

aborque@comz.org

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: OTHER
• Target Duration: 15 Years
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 6, 2016
• First Posted: August 12, 2016
• Study Start: July 1, 2014
• Primary Completion: June 1, 2019
• Study Completion (Estimated): July 1, 2034
• Last Updated: February 12, 2018

Record last verified: 2018-02

Data Sharing

• IPD Sharing: Will share

Locations

ES (1)