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

Universitaire Ziekenhuizen KU Leuven

Status: Enrolling

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

Treatments: Other: standard of care

Study type: Observational

Funder types: Other

Identifiers

NCT04694924

S63359

Details and patient eligibility

About

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.

Enrollment: 5,000 estimated patients

Sex: Male

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

5,000 participants in 1 patient group

Localized and locally advanced prostate cancer

Description:

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.

Treatment:

Other: standard of care