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Clinical trial Recruiting at 1 site Observational Ages 18 to 80 Men only

Registry of prostate cancer patients on active surveillance in Spain

Official title: Spanish Urological Association Registry of Patients on Active Surveillance

Run by Fundación Instituto Valenciano de Oncología · NCT02865330 · Data updated 2026-11-12

This study is creating a registry of prostate cancer patients in Spain who are being monitored without immediate treatment to see how well this approach works over time.

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Quick facts

Study typeObservational
Ages18 Years to 80 Years
SexMen only
Enrollment946 (estimated)
SponsorFundación Instituto Valenciano de Oncología
Academic / other
Locations1 site (Valencia)
StatusRecruiting
StartedJuly 2014
Main results expectedJune 2019
Study endsJuly 2034
Registry record updatedFebruary 12, 2018
Trial IDNCT02865330 on ClinicalTrials.gov

Is this trial a fit for you?

Likely a good fit

Ideal candidates for this study are men under 80 years old with low to intermediate risk prostate cancer who meet specific clinical criteria for active surveillance.

Probably not a fit

Patients with a history of atypical small acinar proliferation or those unwilling to undergo repeat biopsies may not benefit from this study.

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This multicenter observational study aims to create a comprehensive registry of patients with prostate cancer who are undergoing active surveillance in Spain. It includes both retrospective and prospective data collection from various medical centers affiliated with the Spanish Urological Association. The study seeks to standardize the approach to active surveillance and monitor outcomes over time, with a hypothesis that cancer-specific mortality for patients eligible for active surveillance will be less than 5% over 15 years. The registry will help address the variability in active surveillance practices across different centers in Spain.

Why it matters

Potential benefit: If successful, this registry could lead to improved management strategies for prostate cancer, reducing unnecessary treatments and associated side effects.

How similar studies have gone: Other studies have shown success with similar registries and active surveillance approaches, indicating potential for meaningful insights and improvements in patient care.

Who can join: the full rules

Show full inclusion / exclusion criteria 
Inclusion Criteria:

1. PSA ≤ 10 ng / mL; if prostate volume\> 60 cc in transrectal, ultrasound includable with PSA\>10 ng / ml if PSAD \<0.20
2. Local Stadium DRE; cT1c -cT2a
3. Diagnosis of transrectal ultrasound guided biopsy minimum 10 cylinders
4. Adenocarcinoma Prostate Gleason ≤ 6 (3 + 3) with local and central pathology review
5. Maximum number of cylinders = 2 and none of them more than 5mm tumor or more than 50% of assignment
6. \<80 years and greater expectancy to 10 years life (Charlson score)
7. Patients able to understand active surveillance and sign the Informed Consent

Exclusion Criteria:

1. Patient not be able to accept up with repeat biopsies
2. Patient who does not want to sign the Informed Consent
3. Hospital where the possibility of a biopsy confirmation at 6 months is not guaranteed under the terms of the inclusion criteria
4. Patients with a history of ASAP (atypical small acinar proliferation or atypical microglands)
5. Patients with treatment with inhibitors of 5-alpha-reductase as dutasteride (Avidart®) and finasteride (Proscar®) during the previous six months
6. 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's running

  • Instituto Valenciano de Oncología
    Valencia, Spain     Recruiting

Study contacts

  • Principal investigator: Jose Rubio Briones, MD, PhD — Ivo
  • Study coordinator: Jose Rubio Briones, MD, PhD
  • Email: jrubio@fivo.org

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
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Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.