Prospective Prostate Cancer and Patient-reported Outcomes Registry

Prostate Cancer Clinical Trial

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Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04694924
• Other study ID #: S63359
• Status: Recruiting
• Start date: October 1, 2020
• Est. completion date: October 2030

Study information

• Verified date: May 2022
• Source: Universitaire Ziekenhuizen KU Leuven
• Contact: Wouter Everaerts, MD, PhD
• Phone: +3216346687
• Email: wouter.everaerts[@]uzleuven.be
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 5000
• Est. completion date: October 2030
• Est. primary completion date: October 2030
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Adenocarcinoma
• Adenocarcinoma of the Prostate
• Locally Advanced Prostate Adenocarcinoma
• Locally Advanced Prostate Carcinoma
• Prostate Cancer
• Prostatic Neoplasms

Intervention

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.

Locations

Country	Name	City	State
Belgium	AZ Sint-Jan Brugge	Brugge	West-Vlaanderen
Belgium	AZ Sint-Blasius	Dendermonde	Oost-Vlaanderen
Belgium	AZ Groeninge Kortrijk	Kortrijk	West-Vlaanderen
Belgium	University Hospitals Leuven	Leuven	Vlaams-Brabant

Sponsors (4)

Lead Sponsor	Collaborator
Universitaire Ziekenhuizen KU Leuven	AZ Sint-Blasius Dendermonde, AZ Sint-Jan AV, General Hospital Groeninge

Country where clinical trial is conducted

Belgium, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	Prostate Cancer (PC)-related Mortality (PM)	PC-related mortality is the death due to prostate cancer.	up to 10 years after diagnosis