Spanish Urological Association Registry of Patients on Active Surveillance

About This Trial

This study tracks the long-term health of men in Spain with early-stage prostate cancer who choose to closely monitor their disease instead of having immediate treatments like surgery or radiation.
It is designed for men under 80 years old with small, slow-growing tumors that have a low risk of spreading.
Because this is an observational registry rather than a test of a new drug, researchers will simply follow the results of your standard medical care over time.
Before joining, patients should know that this approach requires regular follow-up visits, including repeat prostate biopsies to ensure the cancer remains stable.

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 %.

Age Range: 18 - 80 years
Gender: Male
Who This Trial is For: This study tracks the long-term health of men in Spain with early-stage prostate cancer who choose to closely monitor their disease instead of having immediate treatments like surgery or radiation.

Full Eligibility Criteria

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.