Prospective Prostate Cancer and Patient-reported Outcomes Registry
NCT ID: NCT04694924
Last Updated: 2024-05-22
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
5000 participants
OBSERVATIONAL
2020-10-01
2030-10-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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Localized and locally advanced prostate cancer
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.
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.
Interventions
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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.
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
MALE
No
Sponsors
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AZ Sint-Jan AV
OTHER
General Hospital Groeninge
OTHER
AZ Sint-Blasius Dendermonde
UNKNOWN
Universitaire Ziekenhuizen KU Leuven
OTHER
Responsible Party
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Principal Investigators
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Wouter Everaerts, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
UZ Leuven / KU Leuven
Locations
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AZ Sint-Blasius
Dendermonde, Oost-Vlaanderen, Belgium
University Hospitals Leuven
Leuven, Vlaams-Brabant, Belgium
AZ Sint-Jan Brugge
Bruges, West-Vlaanderen, Belgium
AZ Groeninge Kortrijk
Kortrijk, West-Vlaanderen, Belgium
Countries
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Central Contacts
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Facility Contacts
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Dieter Ost, MD, PhD
Role: primary
Pieter Uvin, MD, PhD
Role: primary
Siska Van Bruwaene, MD, PhD
Role: primary
Other Identifiers
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S63359
Identifier Type: -
Identifier Source: org_study_id
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