Spanish Urological Association Registry of Patients on Active Surveillance
ConditionProstate Cancer
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexMale
Age18-80
SponsorFundación Instituto Valenciano de Oncología
About this trial
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
Qualifiers
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
Disqualifiers
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)
Trial design
Treatments tested in this trial
- Registry
Treatment groups
No treatment groups listed
Sponsors and collaborators
Source ClinicalTrials.gov