Clinical trial NCT02865330: Spanish Urological Association Registry of Patients on Active Surveillance
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Prostate Cancer
Keywords: Intermediate Risk Prostate Cancer
Low Risk Prostate Cancer
Active Surveillance
Lead sponsor: Fundación Instituto Valenciano de Oncología
Sponsor class: OTHER
First posted: 2016-08-12
Enrollment: 946
Sex: MALE
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: OTHER
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Spain male residents diagnosed with low risk PCa (NCCN)

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 %.


Eligibility criteria: 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.

Primary outcomes:
measure: Cancer specific survival in patients in active surveillance
timeFrame: up to 15 years
measure: Overall survival
timeFrame: Date randomization-date death, or up to 15 years, whichever came first
measure: Active treatment-free interval
timeFrame: Date start active surveillance-stop active surveillance due to active treatment, or up to 15 years, whichever came first
measure: Characterization of pathologically agressive tumors by Gleason score
timeFrame: From the study start and stop until 15 years
measure: Characterization of pathologically agressive tumors by TNM
timeFrame: From the study start and stop until 15 years
Secondary outcomes:
measure: Quality of Life in patients with active surveillance
timeFrame: up to 5 years
measure: Quality of Life in patients with active surveillance
timeFrame: up to 5 years
Other outcomes:
Locations:
city: Valencia
country: Spain
facility: Instituto Valenciano de Oncología
Study officials:
affiliation: IVO
name: Jose Rubio Briones, MD, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Hospital Miguel Servet
name: Ángel Borque Fernando, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.