Adenocarcinoma of the Prostate, Locally Advanced Prostate Adenocarcinoma, Locally Advanced Prostate Carcinoma, Prostate Cancer
Conditions
Brief 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.
Interventions
OTHERstandard 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.
Sponsors
AZ Sint-Jan AV
General Hospital Groeninge
AZ Sint-Blasius Dendermonde
Universitaire Ziekenhuizen KU Leuven
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
MALE
Age
18 Years to No maximum
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| General quality of life | at diagnosis, 6 months, 1 year, and annually up to 10 years after diagnosis | 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 |
| Overall Survival (OS) | up to 10 years after diagnosis | Overall survival is defined as the time from enrollment to date of death due to any cause. |
| Prostate Cancer (PC)-related Mortality (PM) | up to 10 years after diagnosis | PC-related mortality is the death due to prostate cancer. |
| Prostate cancer specific quality of life | at diagnosis, 6 months, 1 year, and annually up to 10 years after diagnosis | 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. |
| Occurence of disease recurrence/progression | up to 10 years after diagnosis | Biochemical prostate specific antigen (PSA) recurrence/progression and recurrence/progression based on medical imaging |
Countries
Belgium
Contacts
Primary ContactWouter Everaerts, MD, PhD
Outcome results
None listed