Ireland
--:--IST
Recruiting Observational

Prospective Prostate Cancer and Patient-reported Outcomes Registry

NCT04694924 · tracked via the Priya Life Science Belgium tracker
Phase
Observational
Started
2020-10-01
Last updated
2024-05-22

Condition(s) studied

Prostate CancerAdenocarcinoma of the ProstateLocally Advanced Prostate CarcinomaLocally Advanced Prostate Adenocarcinoma

Investigational drug(s) / intervention(s)

standard of care

standard of care: No other procedures than those performed during the usual care for prostate cancer patients will be done. No study medication will be provided as part of participation. Clinical outcomes will be reported via predefined electronic forms, integrated into the electronic health record (EHR). Patient-reported outcomes will be collected electronically. All treatment decisions will be made at the discretion of the investigator or treating physician.

Study summary

This study aims to evaluate the use of a digital solution, integrated into the electronic health record, for prospective and structured reporting of clinical and patient-reported outcomes for patients diagnosed with localized or locally advanced prostate cancer.

Eligibility

Sex
MALE
Min age
18 Years
Max age
—
Healthy volunteers
No
Inclusion Criteria: * Pathology confirmed diagnosis of localized or locally advanced prostate cancer * Being able to speak, read and understand Dutch, French, or English * Each patient (or their legally acceptable representative) must sign an informed consent form (ICF) indicating that he understands the purpose of, and is willing to participate in the study. Exclusion Criteria: * Patients with prior treatment for prostate malignancies will be excluded. * Dementia, mental alteration, or psychiatric pathology that can compromise informed consent from the patient and/ or adherence to the protocol and the monitoring of the trial * Patients who cannot submit themselves to following the protocol for psychological reasons, social, family, or geographical. * Persons deprived of liberty or under guardianship

Primary outcome measure(s)

  • Assessment of systematically reporting a standardized set of predefined clinical parameters — up to 10 years after diagnosis
    The proportion of patients who are enrolled in the registry over the total localized and locally advanced prostate cancer patients
  • Assessment of systematically collecting a predefined set of patient-reported outcomes — up to 10 years after diagnosis
    The proportion of patients who completed all questionnaires over the total of questionnaires send.

Trial sites (4)

FacilityCityRegionStatus
AZ Sint-Blasius Dendermonde Oost-Vlaanderen Recruiting
University Hospitals Leuven Leuven Vlaams-Brabant Recruiting
AZ Sint-Jan Brugge Bruges West-Vlaanderen Recruiting
AZ Groeninge Kortrijk Kortrijk West-Vlaanderen Recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT04694924 on ClinicalTrials.gov ↗ ← All trials in Belgium