Registry for prostate cancer and patient-reported outcomes
Promoting Quality of Care: a Prospective Cohort Study of Localized and Locally Advanced Prostate Cancer Patients
Universitaire Ziekenhuizen KU Leuven · NCT04694924
This study is testing a new digital tool to help track how men with localized or locally advanced prostate cancer feel and respond to treatment over time.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 5000 (estimated) |
| Ages | 18 Years and up |
| Sex | Male |
| Sponsor | Universitaire Ziekenhuizen KU Leuven (other) |
| Locations | 4 sites (Dendermonde, Oost-Vlaanderen and 3 other locations) |
| Trial ID | NCT04694924 on ClinicalTrials.gov |
What this trial studies
This observational study evaluates a digital solution integrated into electronic health records to systematically report clinical and patient-reported outcomes for patients diagnosed with localized or locally advanced prostate cancer. The study aims to enhance the understanding of patient experiences and treatment effects through structured data collection. Participants will be monitored under standard care protocols while contributing to a comprehensive registry that captures their health outcomes over time.
Who should consider this trial
Good fit: Ideal candidates include individuals with a confirmed diagnosis of localized or locally advanced prostate cancer who can communicate in Dutch, French, or English.
Not a fit: Patients with prior treatments for prostate malignancies or those unable to provide informed consent due to mental health issues may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could improve the management and treatment of prostate cancer by providing valuable insights into patient experiences and outcomes.
How similar studies have performed: Other studies utilizing digital solutions for patient-reported outcomes have shown promise, indicating that this approach may yield valuable data.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Dendermonde, Oost-Vlaanderen and 3 other locations
- AZ Sint-Blasius — Dendermonde, Oost-Vlaanderen, Belgium (RECRUITING)
- University Hospitals Leuven — Leuven, Vlaams-Brabant, Belgium (RECRUITING)
- AZ Sint-Jan Brugge — Bruges, West-Vlaanderen, Belgium (RECRUITING)
- AZ Groeninge Kortrijk — Kortrijk, West-Vlaanderen, Belgium (RECRUITING)
Study contacts
- Principal investigator: Wouter Everaerts, MD, PhD — UZ Leuven / KU Leuven
- Study coordinator: Wouter Everaerts, MD, PhD
- Email: wouter.everaerts@uzleuven.be
- Phone: +3216346687
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Prostate Cancer, Adenocarcinoma of the Prostate, Locally Advanced Prostate Carcinoma, Locally Advanced Prostate Adenocarcinoma