Prosquare: Prospective Prostate Cancer and Patient-reported Outcomes Registry
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| 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. |
Other: 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 EHR. Patient-reported outcomes will be collected electronically.
All treatment decisions will be made at the discretion of the investigator or treating physician.
|
Outcome Measures
Primary Outcome Measures
- 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 Outcome Measures
- 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
- 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 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 [at diagnosis, 6 months, 1 year, and annually up to 10 years after diagnosis]
Measured by 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) [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.
Eligibility Criteria
Criteria
Inclusion Criteria:
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Pathology confirmed diagnosis of localized or locally advanced prostate cancer
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Being able to speak, read and understand Dutch, French, or English
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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:
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Patients with prior treatment for prostate malignancies will be excluded.
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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
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Patients who cannot submit themselves to following the protocol for psychological reasons, social, family, or geographical.
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Persons deprived of liberty or under guardianship
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | AZ Sint-Blasius | Dendermonde | Oost-Vlaanderen | Belgium | 9200 |
| 2 | University Hospitals Leuven | Leuven | Vlaams-Brabant | Belgium | 3000 |
| 3 | AZ Sint-Jan Brugge | Brugge | West-Vlaanderen | Belgium | 8000 |
| 4 | AZ Groeninge Kortrijk | Kortrijk | West-Vlaanderen | Belgium | 8500 |
Sponsors and Collaborators
- Universitaire Ziekenhuizen Leuven
- AZ Sint-Jan AV
- General Hospital Groeninge
- AZ Sint-Blasius Dendermonde
Investigators
- Principal Investigator: Wouter Everaerts, MD, PhD, UZ Leuven / KU Leuven
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- S63359