PSA Glycomics Assay for Early Detection of Prostate Cancer

Prof.dr. H.P. Beerlage150 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

DIAGNOSTIC

Masking

NONE

Enrollment

150

Conditions

Prostate Cancer PSA

Interventions

PSA Glycomics AssayDIAGNOSTIC_TEST

PSA Glycomics Assay will be performed on urine and blood samples

Eligibility

Sex: MALEMin age: 18 YearsHealthy volunteers:

Medical Language ↔ Plain English

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.

Locations (3)

Amsterdam UMC, location AMC

Amsterdam, North Holland, Netherlands

COMPLETED

Amsterdam UMC, location VUmc

Amsterdam, Netherlands

RECRUITING

Leiden University Medical Centre

Leiden, Netherlands

RECRUITING

Outcomes

Primary Outcomes

PSA Glycomics Assay

The relative abundance of glycoforms of PSA in plasma and urine from the subjects will be measured. These will be related to the stage of PCa and compared to non-prostate cancer patients.

Time frame: 1 year

Central Contacts

J R Oddens, MD, PhD

CONTACT

+31(0)20-5668637 j.r.oddens@amsterdamumc.nl

Data from ClinicalTrials.gov

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