Spanish Urological Association Registry of Patients on Active Surveillance

Prostate Cancer Clinical Trial

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02865330
• Other study ID #: AEU-PIEM/2014/0001
• Status: Recruiting
• Phase: N/A
• First received: June 6, 2016
• Last updated: February 9, 2018
• Start date: July 2014
• Est. completion date: July 2034

Study information

• Verified date: February 2018
• Source: Fundación Instituto Valenciano de Oncología
• Contact: Jose Rubio Briones, MD, PhD
• Email: jrubio[@]fivo.org
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical 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.

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 %.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 946
• Est. completion date: July 2034
• Est. primary completion date: June 2019
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years to 80 Years

Eligibility

Inclusion Criteria:

1. PSA = 10 ng / mL; if prostate volume> 60 cc in transrectal, ultrasound includable with PSA>10 ng / ml if PSAD <0.20

2. Local Stadium DRE; cT1c -cT2a

3. Diagnosis of transrectal ultrasound guided biopsy minimum 10 cylinders

4. Adenocarcinoma Prostate Gleason = 6 (3 + 3) with local and central pathology review

5. Maximum number of cylinders = 2 and none of them more than 5mm tumor or more than 50% of assignment

6. <80 years and greater expectancy to 10 years life (Charlson score)

7. Patients able to understand active surveillance and sign the Informed Consent

Exclusion Criteria:

1. Patient not be able to accept up with repeat biopsies

2. Patient who does not want to sign the Informed Consent

3. Hospital where the possibility of a biopsy confirmation at 6 months is not guaranteed under the terms of the inclusion criteria

4. Patients with a history of ASAP (atypical small acinar proliferation or atypical microglands)

5. Patients with treatment with inhibitors of 5-alpha-reductase as dutasteride (Avidart®) and finasteride (Proscar®) during the previous six months

6. 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.

Related Conditions & MeSH terms

• Prostate Cancer
• Prostatic Neoplasms

Intervention

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.

Locations

Country	Name	City	State
Spain	Instituto Valenciano de Oncología	Valencia

Sponsors (1)

Lead Sponsor	Collaborator
Fundación Instituto Valenciano de Oncología

Country where clinical trial is conducted

Spain, 

References & Publications (2)

Borque-Fernando Á, Rubio-Briones J, Esteban LM, Collado-Serra A, Pallás-Costa Y, López-González PÁ, Huguet-Pérez J, Sanz-Vélez JI, Gil-Fabra JM, Gómez-Gómez E, Quicios-Dorado C, Fumadó L, Martínez-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. — View Citation

Rubio-Briones J, Borque A, Esteban LM, Iborra I, López PA, Gil JM, Pallás Y, Fumadó L, Martínez-Breijo S, Chantada V, Gómez E, Quicios C, Congregado CB, Medina R, Ortiz M, Montesino M, Clar F, Soto J, Campá 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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	Quality of Life in patients with active surveillance	Assessed with CAVIPRESS-30 questionaires	up to 5 years
Secondary	Quality of Life in patients with active surveillance	Assessed with EPIC-20 questionaires	up to 5 years

External Links

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