Prospective Prostate Cancer and Patient-reported Outcomes Registry

Study Overview
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Brief Summary
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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.

Official Title
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Promoting Quality of Care: a Prospective Cohort Study of Localized and Locally Advanced Prostate Cancer Patients

Conditions
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Prostate Cancer, Adenocarcinoma of the Prostate, Locally Advanced Prostate Carcinoma, Locally Advanced Prostate Adenocarcinoma

Intervention / Treatment
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* Other: standard of care


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Localized and locally advanced prostate cancer<br>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<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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 | 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 |