Prostate CancerNCT02865330
Spanish Urological Association Registry of Patients on Active Surveillance
An observational study of Prostate Cancer, run by Fundación Instituto Valenciano de Oncología at 1 site in Spain.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 80 years, men only
- Conditions the study is for
- Prostate Cancer
- What is being tested?
- Registry
- How many people
- 946 participants
- Where
- 1 siteSpain
- Study dates
- Jul 2014to Jul 2034
- How long will I take part?
- 15 Years
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- Men only
- No healthy volunteers
- Adult, Older adult
Study population: Spain male residents diagnosed with low risk PCa (NCCN)
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Jose Rubio Briones, MD, PhD contact
Ángel Borque Fernando, MD, PhD contact
Spain1 site, 1 recruiting
- Recruiting
Instituto Valenciano de Oncología
Valencia, 46009
Jose Rubio Briones, MD, PhD, jrubio@fivo.org
Ángel Borque Fernando, MD, PhD, aborque@comz.org
About this study
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.
Read more
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
- Being tested
- Registry
- Keywords
- Intermediate Risk Prostate Cancer, Low Risk Prostate Cancer, Active Surveillance
- Medical subject headings
- Prostatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RegistryOther
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.
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: From the study start and stop until 15 years
Secondary outcomes (2)
Quality of Life in patients with active surveillance
Assessed with CAVIPRESS-30 questionaires
Measured: up to 5 years
Quality of Life in patients with active surveillance
Assessed with EPIC-20 questionaires
Measured: up to 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Aug 2016 (estimated)
- Study startJul 2014
- Primary completionJun 2019 (estimated)
- Study completionJul 2034 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Prostate CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Other
- Enrolment
- 946 participants (estimated)
- Target duration
- 15 Years
Sponsor and investigators
- Lead sponsor
- Fundación Instituto Valenciano de Oncología
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jose Rubio Briones, MD, PhD, Principal investigator, IVOÁngel Borque Fernando, MD, PhD, Principal investigator, Hospital Miguel Servet
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02865330
- Sponsor's protocol ID
- AEU-PIEM/2014/0001
- Status last verified
- Feb 2018
- First submitted
- 6 Jun 2016
- Last updated
- 12 Feb 2018
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Yes
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.2015.05.006. Epub 2015 Jun 23. English, Spanish.
PubMed 26115777Borque-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.
PubMed 29312542Rubio-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.
PubMed 40926355Borque-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.
PubMed 30108375
Study at a glance
From the registry record, last updated by the sponsor on 12 Feb 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Spanish Urological Association Registry of Patients on Active Surveillance
- ClinicalTrials.gov ID
- NCT02865330
- Acronym / sponsor ID
- AEU-PIEM/2014/0001
- Conditions
- Prostate Cancer
- Keywords
- Intermediate Risk Prostate Cancer, Low Risk Prostate Cancer, Active Surveillance
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 946 participants (estimated)
- Lead sponsor
- Fundación Instituto Valenciano de OncologíaUniversity, hospital or other
- Study start
- Jul 2014
- Primary completion
- Jun 2019 (estimated)
- Study completion
- Jul 2034 (estimated)
- First posted
- 12 Aug 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 %.
Study design
- Observational model
- Cohort
- Time perspective
- Other
- Target follow-up
- 15 Years
Who may qualify
- Ages
- 18 to 80 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Spain male residents diagnosed with low risk PCa (NCCN)
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| RegistryNational 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. | Other | – |
Primary outcome
Cancer specific survival in patients in active surveillance
Time frame: up to 15 years
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.
Overall survival
Time frame: Date randomization-date death, or up to 15 years, whichever came first
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.
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
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.
Characterization of pathologically agressive tumors by Gleason score
Time frame: From the study start and stop until 15 years
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.
Characterization of pathologically agressive tumors by TNM
Time frame: From the study start and stop until 15 years
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.
2 secondary outcomes
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Feb 2018.
- Background: PubMed 26115777Rubio-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.
- Background: PubMed 29312542Borque-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.
- Derived from this study: PubMed 40926355Rubio-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.
- Derived from this study: PubMed 30108375Borque-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.
- Enlace a la página web de la asociación Española de UrologíaLink provided by the sponsor.
- Individual participant dataSharing planned: Yes
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Jose Rubio Briones, MD, PhD contact
Ángel Borque Fernando, MD, PhD contact
Jose Rubio Briones, MD, PhD principal investigator
IVO
Ángel Borque Fernando, MD, PhD principal investigator
Hospital Miguel Servet
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Prostate Cancer, run by Fundación Instituto Valenciano de Oncología at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 12 Feb 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Jose Rubio Briones, MD, PhD (jrubio@fivo.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cancer specific survival in patients in active surveillance (time frame: up to 15 years). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02865330, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Feb 2018.