PSA Glycomics Assay for Early Detection of Prostate Cancer

Prostate Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04393376
• Other study ID #: NL73261.018.20
• Status: Recruiting
• Phase: N/A
• Start date: August 1, 2020
• Est. completion date: August 1, 2025

Study information

• Verified date: September 2023
• Source: Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
• Contact: J R Oddens, MD, PhD
• Phone: +31(0)20-5668637
• Email: j.r.oddens[@]amsterdamumc.nl
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 150
• Est. completion date: August 1, 2025
• Est. primary completion date: January 1, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Prostate Cancer
• Prostatic Neoplasms
• PSA

Intervention

Diagnostic Test:
• PSA Glycomics Assay
PSA Glycomics Assay will be performed on urine and blood samples

Locations

Country	Name	City	State
Netherlands	Amsterdam UMC, location AMC	Amsterdam	Noord Holland
Netherlands	Amsterdam UMC, location VUmc	Amsterdam
Netherlands	Leiden University Medical Centre	Leiden

Sponsors (5)

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

Country where clinical trial is conducted

Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	1 year