PSA Glycomics Assay for Early Detection of Prostate Cancer

Prof.dr. H.P. Beerlage

Status: Enrolling

Conditions: Prostate Cancer; PSA

Treatments: Diagnostic Test: PSA Glycomics Assay

Study type: Interventional

Funder types: Other

Identifiers

NCT04393376

NL73261.018.20

Details and patient eligibility

About

The principal aim of this pilot study is to test whether the PSA Glycomics Assay on urine and serum samples can provide insights regarding the disease state of patients with elevated PSA concentrations, as well as to accurately identify if the patient has prostate cancer and, in the case of prostate cancer, to determine its level of aggressiveness.

Enrollment: 150 estimated patients

Sex: Male

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Patients with elevated PSA (>3 ng/mL)
• Signed informed consent

Exclusion criteria

• Patients that have a cystitis (bladder infection)
• Patients under chemotherapy
• Patients using 5-alpha reductase inhibitors
• History or presence of cancers, or non-prostate urological disorders.

Trial design

Primary purpose: Diagnostic

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)