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.
Study Type
OBSERVATIONAL
Enrollment
5,000
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.
AZ Sint-Blasius
Dendermonde, Oost-Vlaanderen, Belgium
RECRUITINGUniversity Hospitals Leuven
Leuven, Vlaams-Brabant, Belgium
RECRUITINGAZ Sint-Jan Brugge
Bruges, West-Vlaanderen, Belgium
RECRUITINGAssessment 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
Time frame: up to 10 years after diagnosis
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.
Time frame: up to 10 years after diagnosis
Occurence of disease recurrence/progression
Biochemical prostate specific antigen (PSA) recurrence/progression and recurrence/progression based on medical imaging
Time frame: up to 10 years after diagnosis
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
Time frame: at diagnosis, 6 months, 1 year, and annually up to 10 years after diagnosis
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.
Time frame: at diagnosis, 6 months, 1 year, and annually up to 10 years after diagnosis
Overall Survival (OS)
Overall survival is defined as the time from enrollment to date of death due to any cause.
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AZ Groeninge Kortrijk
Kortrijk, West-Vlaanderen, Belgium
RECRUITINGTime frame: up to 10 years after diagnosis
Prostate Cancer (PC)-related Mortality (PM)
PC-related mortality is the death due to prostate cancer.
Time frame: up to 10 years after diagnosis