Spanish Urological Association Registry of Patients on Active Surveillance
Recruiting · NCT02865330 · Observational (researchers observe without assigning treatment) · Lead sponsor: Fundación Instituto Valenciano de Oncología
View the official record on ClinicalTrials.gov →Interventions studied
What this trial is about
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 %.
Who can take part
Inclusion criteria
- 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
Exclusion criteria
- 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.
Where it is running
1 location listed.
- Instituto Valenciano de Oncología - Valencia, Spain