Prospective Prostate Cancer and Patient-reported Outcomes Registry (Prosquare)

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

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.

Study Overview

• Status: Recruiting
• Conditions: Prostate Cancer; Adenocarcinoma of the Prostate; Locally Advanced Prostate Carcinoma; Locally Advanced Prostate Adenocarcinoma
• Intervention / Treatment: Other: standard of care

• Study Type: Observational
• Enrollment (Anticipated): 5000

Contacts and Locations

Study Locations

• Belgium
  • Oost-Vlaanderen
    • Dendermonde, Oost-Vlaanderen, Belgium, 9200
      • Recruiting
      • AZ Sint-Blasius
  • Vlaams-Brabant
    • Leuven, Vlaams-Brabant, Belgium, 3000
      • Recruiting
      • University Hospitals Leuven
  • West-Vlaanderen
    • Brugge, West-Vlaanderen, Belgium, 8000
      • Recruiting
      • AZ Sint-Jan Brugge
    • Kortrijk, West-Vlaanderen, Belgium, 8500
      • Recruiting
      • AZ Groeninge Kortrijk

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Male

• 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.

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort

Intervention / Treatment

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; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Occurence of disease recurrence/progression	Biochemical prostate specific antigen (PSA) recurrence/progression and recurrence/progression based on medical imaging	up to 10 years after diagnosis
Overall Survival (OS)	Overall survival is defined as the time from enrollment to date of death due to any cause.	up to 10 years after diagnosis
Prostate Cancer (PC)-related Mortality (PM)	PC-related mortality is the death due to prostate cancer.	up to 10 years after diagnosis
General quality of life	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	at diagnosis, 6 months, 1 year, and annually up to 10 years after diagnosis
Prostate cancer specific quality of life	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.	at diagnosis, 6 months, 1 year, and annually up to 10 years after diagnosis

Collaborators and Investigators

• Sponsor: Universitaire Ziekenhuizen KU Leuven
• Collaborators: AZ Sint-Jan AV; General Hospital Groeninge; AZ Sint-Blasius Dendermonde

Study record dates

Study Major Dates

• Study Start (Actual): October 1, 2020
• Primary Completion (Anticipated): October 1, 2030
• Study Completion (Anticipated): October 1, 2030

Study Registration Dates

• First Submitted: December 24, 2020
• First Submitted That Met QC Criteria: January 4, 2021
• First Posted (Actual): January 5, 2021

Study Record Updates

• Last Update Posted (Actual): April 3, 2023
• Last Update Submitted That Met QC Criteria: March 30, 2023
• Last Verified: May 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms by Histologic Type; Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Carcinoma; Neoplasms, Glandular and Epithelial; Genital Neoplasms, Male; Prostatic Diseases; Prostatic Neoplasms; Adenocarcinoma
• Other Study ID Numbers: S63359

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No