RecruitingNCT02865330

Spanish Urological Association Registry of Patients on Active Surveillance


Sponsor

Fundación Instituto Valenciano de Oncología

Enrollment

946 participants

Start Date

Jul 1, 2014

Study Type

OBSERVATIONAL

Conditions

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

Sex: MALEMin Age: 18 YearsMax Age: 80 Years

Plain Language Summary

Simplified for easier understanding

This study is building a national registry in Spain to track men who choose active surveillance for low-risk prostate cancer — meaning they are being carefully monitored with regular tests rather than immediately treated — to understand the long-term outcomes of this approach. **You may be eligible if...** - Your PSA blood marker is 10 or below (or meets special criteria if your prostate is enlarged) - Your prostate cancer is low-grade (Gleason 6) confirmed by biopsy and specialist review - No more than 2 biopsy samples contain cancer, and the amount of cancer in each sample is limited - Your cancer appears confined to the prostate at an early stage - You are under 80 years old with a life expectancy of more than 10 years - You understand what active surveillance means and have signed a consent form **You may NOT be eligible if...** - You are unwilling to undergo repeat biopsies as part of monitoring - You refuse to sign the informed consent form - Your treating hospital cannot perform a confirmatory biopsy at 6 months Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

OTHERRegistry

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(1)

Instituto Valenciano de Oncología

Valencia, Spain

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NCT02865330


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