RecruitingNCT04694924

Prospective Prostate Cancer and Patient-reported Outcomes Registry

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


Sponsor

Universitaire Ziekenhuizen KU Leuven

Enrollment

5,000 participants

Start Date

Oct 1, 2020

Study Type

OBSERVATIONAL

Conditions

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

Sex: MALEMin Age: 18 Years

Inclusion Criteria3

  • 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 Criteria4

  • 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

Interventions

OTHERstandard 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(4)

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

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NCT04694924


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