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NCT Number: NCT04694924

Prospective Prostate Cancer and Patient-reported Outcomes Registry

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.

Recruiting

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Key information

Conditions

Prostate Cancer Adenocarcinoma of the Prostate Genital Diseases Genital Diseases, Male Genital Neoplasms, Male Locally Advanced Prostate Adenocarcinoma Locally Advanced Prostate Carcinoma Male Urogenital Diseases Neoplasms Neoplasms by Site Prostatic Diseases Prostatic Neoplasms Urogenital Diseases Urogenital Neoplasms

Age range

18 year and older

Sex eligibility

Male

Study type

Observational

Primary location

AZ Sint-Blasius, Dendermonde, Oost-Vlaanderen, Belgium

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Primary outcomes

  1. Assessment of systematically reporting a standardized set of predefined clinical parameters

    Time frame: up to 10 years after diagnosis

    The proportion of patients who are enrolled in the registry over the total localized and locally advanced prostate cancer patients

  2. Assessment of systematically collecting a predefined set of patient-reported outcomes

    Time frame: up to 10 years after diagnosis

    The proportion of patients who completed all questionnaires over the total of questionnaires send.

Secondary outcomes

  1. Occurence of disease recurrence/progression

    Time frame: up to 10 years after diagnosis

    Biochemical prostate specific antigen (PSA) recurrence/progression and recurrence/progression based on medical imaging

  2. General quality of life

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

    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

  3. Prostate cancer specific quality of life

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

    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.

  4. Overall Survival (OS)

    Time frame: up to 10 years after diagnosis

    Overall survival is defined as the time from enrollment to date of death due to any cause.

  5. Prostate Cancer (PC)-related Mortality (PM)

    Time frame: up to 10 years after diagnosis

    PC-related mortality is the death due to prostate cancer.

Study contacts

Contact information is provided by the study sponsor or research team.

Wouter Everaerts, MD, PhD

CONTACT

[email protected]

+3216346687

Sponsors and collaborators

Lead sponsor

Universitaire Ziekenhuizen KU Leuven

Other

Collaborators

  • AZ Sint-Blasius Dendermonde
  • AZ Sint-Jan AV
  • General Hospital Groeninge

Registry information

Official study title

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

Acronym: Prosquare

Important dates

Study start
2020
Primary completion
2030
Study completion
2030
First posted
Jan 5, 2021
Registry last updated
May 22, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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