Spanish Urological Association Registry of Patients on Active Surveillance

Recruiting

• Conditions: Prostate Cancer

• Registration Number: NCT02865330
• Lead Sponsor: Fundación Instituto Valenciano de Oncología

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 %.

Detailed Description

Not available

Study Timeline

• Study Start: 2014-07
• Study First Submitted: 2016-06-06
• Study First Submitted QC: 2016-08-09
• Study First Posted: 2016-08-12
• Status Verified: 2018-02
• Last Update Submitted: 2018-02-09
• Last Update Posted: 2018-02-12
• Primary Completion: 2019-06
• Study Completion: 2034-07

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Male
• Target Recruitment: 946

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Active treatment-free interval	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.
Cancer specific survival in patients in active surveillance	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.
Overall survival	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.
Characterization of pathologically agressive tumors by Gleason score	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.
Characterization of pathologically agressive tumors by TNM	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.

Secondary Outcome Measures

Name	Time	Method
Quality of Life in patients with active surveillance	up to 5 years	Assessed with EPIC-20 questionaires

Trial Locations

Locations (1)

Instituto Valenciano de Oncología; 🇪🇸 Valencia, Spain