Spanish Urological Association Registry of Patients on Active Surveillance
ConditionProstate Cancer
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexMale
Age18-80
SponsorFundación Instituto Valenciano de Oncología
About this trial
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
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
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
Patients with a history of ASAP (atypical small acinar proliferation or atypical microglands)
Trial population
Spain male residents diagnosed with low risk PCa (NCCN)
Trial design
Design model
Cohort
Time perspective
Other
Treatments tested in this trial
Registry
Other interventionNational 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.
Treatment groups
No treatment groups listed
Trial outcomes
Primary outcomes
1
Cancer specific survival in patients in active surveillance
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
up to 15 years2
Overall survival
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 randomization-date death, or up to 15 years, whichever came first3
Active treatment-free interval
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
Date start active surveillance-stop active surveillance due to active treatment, or up to 15 years, whichever came first4
Characterization of pathologically agressive tumors by Gleason score
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 yearsSecondary outcomes
1
Quality of Life in patients with active surveillance
Assessed with CAVIPRESS-30 questionaires
Time frame
up to 5 years2
Quality of Life in patients with active surveillance
Assessed with EPIC-20 questionaires
Time frame
up to 5 yearsSponsors and contacts
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Source ClinicalTrials.gov