NCT02865330Recruiting
Spanish Urological Association Registry of Patients on Active Surveillance
Source: ClinicalTrials.gov · Last updated 12 Feb 2018 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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 %.
- Status (registry)
- Recruiting
- Study type
- Observational
- Enrollment
- 946 (estimated)
- First submitted
- 6 Jun 2016
- Start date
- 1 Jul 2014
- Primary completion date
- 30 Jun 2019
- Lead sponsor
- Fundación Instituto Valenciano de Oncología
- Diseases
- Prostate cancer
- NCT number
- NCT02865330
What you commit to
- Study type: Observational
- Planned participants: 946
- From 1 Jul 2014 to the primary completion date, 30 Jun 2019
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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.
Other illness
- Patients with a history of ASAP (atypical small acinar proliferation or atypical microglands)
Other
- 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
Who the study is looking for
- 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
Age in the registry: 18 years to 80 years · Sex: Male · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Instituto Valenciano de Oncologia Coordinator of this site? Confirm its status | Valencia | Spain | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.