Evaluation of Prostate-Specific Antigen Glycomics Assay for the Early Detection of Prostate Cancer

Prof.dr. H.P. Beerlage3 sites in 1 country150 target enrollmentAugust 1, 2020

ConditionsProstate Cancer PSA

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Prostate Cancer
Sponsor: Prof.dr. H.P. Beerlage
Enrollment: 150
Locations: 3
Primary Endpoint: PSA Glycomics Assay
Status: Recruiting
Last Updated: 2 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

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.

Registry

clinicaltrials.gov

Start Date

August 1, 2020

End Date

August 1, 2025

Last Updated

2 years ago

Study Type

Interventional

Study Design

Single Group

Sex

Male

Investigators

Sponsor

Prof.dr. H.P. Beerlage

Responsible Party

Sponsor Investigator

Principal Investigator

Prof.dr. H.P. Beerlage

Urologist, Head of Department of Urology

Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)

Eligibility Criteria

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.

Outcomes

Primary Outcomes

PSA Glycomics Assay

Time Frame: 1 year

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.