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PSA Glycomics Assay for Early Detection of Prostate Cancer

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

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04393376
Enrollment
150
Registered
2020-05-19
Start date
2020-08-01
Completion date
2025-08-01
Last updated
2023-09-26

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Prostate Cancer, PSA

Keywords

Prostate Cancer, PSA, Glycomics Assay

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.

Interventions

DIAGNOSTIC_TESTPSA Glycomics Assay

PSA Glycomics Assay will be performed on urine and blood samples

Sponsors

Amsterdam UMC, location VUmc
CollaboratorOTHER
The Netherlands Cancer Institute
CollaboratorOTHER
Radboud University Medical Center
CollaboratorOTHER
Leiden University Medical Center
CollaboratorOTHER
Prof.dr. H.P. Beerlage
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE

Eligibility

Sex/Gender
MALE
Age
18 Years to No maximum
Healthy volunteers
Yes

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.

Design outcomes

Primary

MeasureTime frameDescription
PSA Glycomics Assay1 yearThe 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.

Countries

Netherlands

Contacts

Primary ContactJ R Oddens, MD, PhD
j.r.oddens@amsterdamumc.nl+31(0)20-5668637

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026