Prospective Prostate Cancer and Patient-reported Outcomes Registry

NCT ID: NCT04694924

Last Updated: 2024-05-22

Study Results

Results pending

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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Recruitment Status

RECRUITING

Total Enrollment

5000 participants

Study Classification

OBSERVATIONAL

Study Start Date

2020-10-01

Study Completion Date

2030-10-31

Brief Summary

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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.

Detailed Description

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Conditions

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

Study Design

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Observational Model Type

COHORT

Study Time Perspective

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

Intervention Type 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.

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.

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

No

Sponsors

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AZ Sint-Jan AV

OTHER

Sponsor Role collaborator

General Hospital Groeninge

OTHER

Sponsor Role collaborator

AZ Sint-Blasius Dendermonde

UNKNOWN

Sponsor Role collaborator

Universitaire Ziekenhuizen KU Leuven

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

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

Site Status RECRUITING

University Hospitals Leuven

Leuven, Vlaams-Brabant, Belgium

Site Status RECRUITING

AZ Sint-Jan Brugge

Bruges, West-Vlaanderen, Belgium

Site Status RECRUITING

AZ Groeninge Kortrijk

Kortrijk, West-Vlaanderen, Belgium

Site Status RECRUITING

Countries

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Belgium

Central Contacts

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Wouter Everaerts, MD, PhD

Role: CONTACT

+3216346687

Facility Contacts

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Dieter Ost, MD, PhD

Role: primary

052 25 25 05

Wouter Everaerts, MD, PhD

Role: primary

016346687

Pieter Uvin, MD, PhD

Role: primary

050 45 25 30

Siska Van Bruwaene, MD, PhD

Role: primary

056 63 38 00

Other Identifiers

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S63359

Identifier Type: -

Identifier Source: org_study_id

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