NCT02865330 Spanish Urological Association Registry of Patients on Active Surveillance
| NCT ID | NCT02865330 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Fundación Instituto Valenciano de Oncología |
| Condition | Prostate Cancer |
| Study Type | OBSERVATIONAL |
| Enrollment | 946 participants |
| Start Date | 2014-07 |
| Primary Completion | 2019-06 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 946 participants in total. It began in 2014-07 with a primary completion date of 2019-06.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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 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.
Contact & Investigator
Jose Rubio Briones, MD, PhD
✉ jrubio@fivo.orgJose Rubio Briones, MD, PhD
PRINCIPAL INVESTIGATOR
IVO
Frequently Asked Questions
Who can join the NCT02865330 clinical trial?
This trial is open to male participants only, aged 18 Years or older, up to 80 Years, studying Prostate Cancer. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT02865330 currently recruiting?
Yes, NCT02865330 is actively recruiting participants. Contact the research team at jrubio@fivo.org for enrollment information.
Where is the NCT02865330 trial being conducted?
This trial is being conducted at Valencia, Spain.
Who is sponsoring the NCT02865330 clinical trial?
NCT02865330 is sponsored by Fundación Instituto Valenciano de Oncología. The principal investigator is Jose Rubio Briones, MD, PhD at IVO. The trial plans to enroll 946 participants.
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