Instituto Valenciano de Oncología
Valencia, 46009, Spain
Location status: Recruiting
Location contact
Jose Rubio Briones, MD, PhD
CONTACT
Ángel Borque Fernando, MD, PhD
CONTACT
NCT Number: NCT02865330
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 %.
Interested in participating?
Request Info18 year–80 year
Male
Observational
Valencia, 46009, Spain
Location status: Recruiting
Jose Rubio Briones, MD, PhD
CONTACT
Ángel Borque Fernando, MD, PhD
CONTACT
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
National Registry of patients with prostate cancer as monitored through active surveillance, with the intention of testing the hypothesis that cancer-specific mortality in very low-risk and low-risk patients is less than 5% at 15 years.
Time frame: up to 15 years
Global CSS will be recorded, independently of each Center protocol, from enrollment to death due to PRostate Cancer Estimated CSS will be analyzed at 5, 10 and 15 years from initiation of the protocol.
To this purpose, patients will be followed although they progressed and went into active treatment.
Time frame: Date randomization-date death, or up to 15 years, whichever came first
Global OS will be recorded, independently of each Center protocol, from enrollment to death of any cause Estimated OS will be analyzed at 5, 10 and 15 years from initiation of the protocol To this purpose, patients will be followed although they progressed and went into active treatment or if the kept in active surveillance till their death due to any cause.
Time frame: Date start active surveillance-stop active surveillance due to active treatment, or up to 15 years, whichever came first
Time to active treatment will be recorded, independently of each Center protocol, from enrollment to any other active due to prostate cancer progression or patient desire to receive any active treatment Estimated active treatment free survival will be analyzed at 2, 5 and 10 years from initiation of the protocol.
Time frame: From the study start and stop until 15 years
Characterization of pathologically agressive tumours will be done by analyzing the pathological reports of radical prostatectomy specimens derived from patients included in the protocol that went on to radical prostatectomy. This has no time frame, although time of radical prostatectomy will be a variable to take in account for comparisions among different timings of performace of radical prostatectomies.
Time frame: From the study start and stop until 15 years
Characterization of pathologically agressive tumours will be done by analyzing the pathological reports of radical prostatectomy specimens derived from patients included in the protocol that went on to radical prostatectomy. This has no time frame, although time of radical prostatectomy will be a variable to take in account for comparisions among different timings of performace of radical prostatectomies.
Time frame: up to 5 years
Assessed with CAVIPRESS-30 questionaires
Time frame: up to 5 years
Assessed with EPIC-20 questionaires
Contact information is provided by the study sponsor or research team.
Jose Rubio Briones, MD, PhD
CONTACT
Ángel Borque Fernando, MD, PhD
CONTACT
Fundación Instituto Valenciano de Oncología
Other
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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