Spanish Urological Association Registry of Patients on Active Surveillance

Recruiting now

Conditions studied: Prostate Cancer

In brief

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 %.

Key facts

Study ID

NCT02865330

Run by

Fundación Instituto Valenciano de Oncología

People needed

946

Starts

2014-07-01

Expected to finish

2034-07-01

Last updated by the study team

2018-02-12

Who can join

Age: 18 and older, up to 80. Sex: male. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

• Instituto Valenciano de Oncología — Valencia, Spain (enrolling)

Full record on ClinicalTrials.gov

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