Clinical trial NCT04694924: Prospective Prostate Cancer and Patient-reported Outcomes Registry
Official title: Promoting Quality of Care: a Prospective Cohort Study of Localized and Locally Advanced Prostate Cancer Patients
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Prostate Cancer
Adenocarcinoma of the Prostate
Locally Advanced Prostate Carcinoma
Locally Advanced Prostate Adenocarcinoma
Lead sponsor: Universitaire Ziekenhuizen KU Leuven
Sponsor class: OTHER
Collaborators: name: AZ Sint-Jan AV
name: General Hospital Groeninge
name: AZ Sint-Blasius Dendermonde
First posted: 2021-01-05
Enrollment: 5000
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All patients with newly diagnosed histologically proven localized and locally advanced prostate cancer referred to one of the participating sites will be eligible to be enrolled in the cohort.

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.


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

Primary outcomes:
measure: Assessment of systematically reporting a standardized set of predefined clinical parameters
timeFrame: up to 10 years after diagnosis
measure: Assessment of systematically collecting a predefined set of patient-reported outcomes
timeFrame: up to 10 years after diagnosis
Secondary outcomes:
measure: Occurence of disease recurrence/progression
timeFrame: up to 10 years after diagnosis
measure: General quality of life
timeFrame: at diagnosis, 6 months, 1 year, and annually up to 10 years after diagnosis
measure: Prostate cancer specific quality of life
timeFrame: at diagnosis, 6 months, 1 year, and annually up to 10 years after diagnosis
measure: Overall Survival (OS)
timeFrame: up to 10 years after diagnosis
measure: Prostate Cancer (PC)-related Mortality (PM)
timeFrame: up to 10 years after diagnosis
Other outcomes:
Locations:
city: Dendermonde
country: Belgium
facility: AZ Sint-Blasius
state: Oost-Vlaanderen
city: Leuven
country: Belgium
facility: University Hospitals Leuven
state: Vlaams-Brabant
city: Brugge
country: Belgium
facility: AZ Sint-Jan Brugge
state: West-Vlaanderen
city: Kortrijk
country: Belgium
facility: AZ Groeninge Kortrijk
state: West-Vlaanderen
Study officials:
affiliation: UZ Leuven / KU Leuven
name: Wouter Everaerts, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: