Recruiting NCT04694924
Prospective Prostate Cancer and Patient-reported Outcomes Registry
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: standard of care.
- Who it may be relevant to
- Registry conditions: Prostate Cancer, Adenocarcinoma of the Prostate, Locally Advanced Prostate Carcinoma, Locally Advanced Prostate Adenocarcinoma. Basic parameters: from 18 years · Male.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Belgium
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Promoting Quality of Care: a Prospective Cohort Study of Localized and Locally Advanced Prostate Cancer Patients
Overview
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
- 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 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.
Primary outcome measures
- Assessment of systematically reporting a standardized set of predefined clinical parameters [Time frame: up to 10 years after diagnosis]
- Assessment of systematically collecting a predefined set of patient-reported outcomes [Time frame: up to 10 years after diagnosis]
Secondary outcome measures (5)
- Occurence of disease recurrence/progression [Time frame: up to 10 years after diagnosis]
- General quality of life [Time frame: at diagnosis, 6 months, 1 year, and annually up to 10 years after diagnosis]
- Prostate cancer specific quality of life [Time frame: at diagnosis, 6 months, 1 year, and annually up to 10 years after diagnosis]
- Overall Survival (OS) [Time frame: up to 10 years after diagnosis]
- Prostate Cancer (PC)-related Mortality (PM) [Time frame: up to 10 years after diagnosis]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
Belgium · 4 centers
- AZ Sint-Blasius — Dendermonde
- University Hospitals Leuven — Leuven
- AZ Sint-Jan Brugge — Bruges
- AZ Groeninge Kortrijk — Kortrijk
Identifiers
NCT: NCT04694924 · S63359