Actively Recruiting
Spanish Urological Association Registry of Patients on Active Surveillance
Led by Fundación Instituto Valenciano de Oncología · Updated on 2018-02-12
946
Participants Needed
1
Research Sites
1043 weeks
Total Duration
On this page
AI-Summary
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 %.
CONDITIONS
Official Title
Spanish Urological Association Registry of Patients on Active Surveillance
Who Can Participate
Eligibility Criteria
You may qualify if you...
- PSA 10 ng/mL; if prostate volume > 60 cc by transrectal ultrasound, PSA > 10 ng/mL is includable if PSA density < 0.20
- Clinical local stage DRE; cT1c to cT2a
- Diagnosis based on transrectal ultrasound guided biopsy with at least 10 cylinders
- Prostate adenocarcinoma Gleason score 6 (3 + 3) confirmed by local and central pathology review
- Maximum of 2 positive biopsy cylinders, none showing more than 5 mm tumor or more than 50% involvement
- Age under 80 years with life expectancy over 10 years (Charlson score)
- Ability to understand active surveillance and provide informed consent
You will not qualify if you...
- Unable to accept repeat biopsies
- Unwilling to sign informed consent
- Hospital unable to guarantee biopsy confirmation at 6 months per inclusion criteria
- History of ASAP (atypical small acinar proliferation or atypical microglands)
- Treatment with 5-alpha-reductase inhibitors (dutasteride or finasteride) in the previous 6 months
- Treatment for symptomatic benign prostate hyperplasia or any invasive urological procedure in the past 6 months, including prostate biopsy, thermotherapy, microwave therapy, laser, urethral resection, catheterization, or lower genitourinary tract endoscopy
AI-Screening
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Trial Site Locations
Total: 1 location
1
Instituto Valenciano de Oncología
Valencia, Spain, 46009
Actively Recruiting
Research Team
J
Jose Rubio Briones, MD, PhD
CONTACT
Á
Ángel Borque Fernando, MD, PhD
CONTACT
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
0
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