Prospective Prostate Cancer and Patient-reported Outcomes Registry

Recruiting

• Conditions: Locally Advanced Prostate Carcinoma; Prostate Cancer; Locally Advanced Prostate Adenocarcinoma; Adenocarcinoma of the Prostate
• Interventions: Other: standard of care

• Registration Number: NCT04694924
• Lead Sponsor: Universitaire Ziekenhuizen KU Leuven

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2020-10-01
• Study First Submitted: 2020-12-24
• Study First Submitted QC: 2021-01-04
• Study First Posted: 2021-01-05
• Status Verified: 2024-05
• Last Update Submitted: 2024-05-21
• Last Update Posted: 2024-05-22
• Primary Completion: 2030-10
• Study Completion: 2030-10

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Male
• Target Recruitment: 5000

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Localized and locally advanced prostate cancer	standard of care	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.

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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 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
Prostate cancer specific quality of life	at diagnosis, 6 months, 1 year, and annually up to 10 years after diagnosis	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.
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.

Trial Locations

Locations (4)

AZ Sint-Blasius; 🇧🇪 Dendermonde, Oost-Vlaanderen, Belgium

AZ Groeninge Kortrijk; 🇧🇪 Kortrijk, West-Vlaanderen, Belgium

University Hospitals Leuven; 🇧🇪 Leuven, Vlaams-Brabant, Belgium

AZ Sint-Jan Brugge; 🇧🇪 Brugge, West-Vlaanderen, Belgium