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| Name | Class |
|---|---|
| AZ Sint-Jan AV | OTHER |
| General Hospital Groeninge | OTHER |
| AZ Sint-Blasius Dendermonde | UNKNOWN |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Localized and locally advanced prostate cancer | Localized prostate cancer (cT1a-T2c N0 M0) refers to the clinical condition where cancer is confined to the prostate gland, in the absence of lymph node invasion or metastases. Locally advanced refers to the extension of the tumor beyond the capsule of the prostate (cT3-T4) or the clinical presence of nodal invasion (cN+), without metastases. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| standard of care | Other | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | 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. | up to 10 years after diagnosis |
| Measure | Description | Time Frame |
|---|---|---|
| Occurence of disease recurrence/progression | Biochemical prostate specific antigen (PSA) recurrence/progression and recurrence/progression based on medical imaging | up to 10 years after diagnosis |
| General quality of life |
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Inclusion Criteria:
Exclusion Criteria:
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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.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Wouter Everaerts, MD, PhD | Contact | +3216346687 | wouter.everaerts@uzleuven.be |
| Name | Affiliation | Role |
|---|---|---|
| Wouter Everaerts, MD, PhD | UZ Leuven / KU Leuven | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| AZ Sint-Blasius | Recruiting | Dendermonde | Oost-Vlaanderen | 9200 | Belgium |
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| ID | Term |
|---|---|
| D011471 | Prostatic Neoplasms |
| ID | Term |
|---|---|
| D005834 | Genital Neoplasms, Male |
| D014565 | Urogenital Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
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| ID | Term |
|---|---|
| D059039 | Standard of Care |
| ID | Term |
|---|---|
| D019984 | Quality Indicators, Health Care |
| D011787 | Quality of Health Care |
| D006298 | Health Services Administration |
| D017530 | Health Care Quality, Access, and Evaluation |
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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
| 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. | 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. | up to 10 years after diagnosis |
| Prostate Cancer (PC)-related Mortality (PM) | PC-related mortality is the death due to prostate cancer. | up to 10 years after diagnosis |
| University Hospitals Leuven | Recruiting | Leuven | Vlaams-Brabant | 3000 | Belgium |
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| AZ Sint-Jan Brugge | Recruiting | Bruges | West-Vlaanderen | 8000 | Belgium |
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| AZ Groeninge Kortrijk | Recruiting | Kortrijk | West-Vlaanderen | 8500 | Belgium |
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| D005832 |
| Genital Diseases, Male |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D011469 | Prostatic Diseases |
| D052801 | Male Urogenital Diseases |