Prospective Prostate Cancer and Patient-reported Outcomes Registry

NCT04694924 | Recruiting

• 1 other identifier: S63359
• Study Type: observational
• Target: 5,000
• Locations: 1 country
• Sites: 4

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.

Conditions

Prostate Cancer; Adenocarcinoma of the Prostate; Locally Advanced Prostate Carcinoma; Locally Advanced Prostate Adenocarcinoma

Outcome Measures

Primary Outcomes (2)

• 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

• 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 Outcomes (5)

• Occurence of disease recurrence/progression

  up to 10 years after diagnosis

• General quality of life

  at diagnosis, 6 months, 1 year, and annually up to 10 years after diagnosis

• Prostate cancer specific quality of life

  at diagnosis, 6 months, 1 year, and annually up to 10 years after diagnosis

• Overall Survival (OS)

  up to 10 years after diagnosis

• Prostate Cancer (PC)-related Mortality (PM)

  up to 10 years after diagnosis

Study Arms (1)

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.

Other: standard of care

Interventions

standard of care OTHER

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.

Localized and locally advanced prostate cancer

Eligibility Criteria

• Age: 18 Years+
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Universitaire Ziekenhuizen KU Leuven: lead
• AZ Sint-Jan AV: collaborator
• General Hospital Groeninge: collaborator
• AZ Sint-Blasius Dendermonde: collaborator

Study Sites (4)

AZ Sint-Blasius

Dendermonde, Oost-Vlaanderen, 9200, Belgium

RECRUITING

University Hospitals Leuven

Leuven, Vlaams-Brabant, 3000, Belgium

RECRUITING

AZ Sint-Jan Brugge

Bruges, West-Vlaanderen, 8000, Belgium

RECRUITING

AZ Groeninge Kortrijk

Kortrijk, West-Vlaanderen, 8500, Belgium

RECRUITING

MeSH Terms

Conditions

Prostatic Neoplasms

Interventions

Standard of Care

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases

Intervention Hierarchy (Ancestors)

Quality Indicators, Health Care; Quality of Health Care; Health Services Administration; Health Care Quality, Access, and Evaluation

Study Officials

• Wouter Everaerts, MD, PhD

  UZ Leuven / KU Leuven

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Wouter Everaerts, MD, PhD

CONTACT

+3216346687; wouter.everaerts@uzleuven.be

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 10 Years
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 24, 2020
• First Posted: January 5, 2021
• Study Start: October 1, 2020
• Primary Completion (Estimated): October 1, 2030
• Study Completion (Estimated): October 1, 2030
• Last Updated: May 22, 2024

Record last verified: 2024-05

Locations

BE (4)