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.
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.
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
All patients with newly diagnosed histologically proven localized and locally advanced prostate cancer referred to one of the participating sites will be eligible to be enrolled in the cohort.
Cohort
Prospective
standard of care
Other interventionNo 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.
Assessment of systematically reporting a standardized set of predefined clinical parameters
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
The proportion of patients who completed all questionnaires over the total of questionnaires send.
Occurence of disease recurrence/progression
Biochemical prostate specific antigen (PSA) recurrence/progression and recurrence/progression based on medical imaging
General quality of life
Assessment of health-related quality of life in prostate cancer patients. Measured by EORTC Quality of Life Questionnaire C30 (QLQ-C30). The EORTC QLQ-C30 is a generic QoL questionnaire designed to cover issues important to all cancer patients
Prostate cancer specific quality of life
Measured by Extended Prostate cancer Index Composite 26 (EPIC26). EPIC-26 is a validated instrument that measures the quality of life across 5 disease-specific domains: urinary incontinence, urinary obstruction and irritation, bowel-related symptoms, sexual dysfunction, and hormonal symptoms.
Overall Survival (OS)
Overall survival is defined as the time from enrollment to date of death due to any cause.
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Universitaire Ziekenhuizen KU Leuven
Lead sponsor
AZ Sint-Jan AV
Collaborator
General Hospital Groeninge
Collaborator
AZ Sint-Blasius Dendermonde
Collaborator
