PSA Glycomics Assay for Early Detection of Prostate Cancer

Not Applicable

Recruiting

• Conditions: Prostate Cancer; PSA

• Registration Number: NCT04393376
• Lead Sponsor: Prof.dr. H.P. Beerlage

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2020-05-14
• Study First Submitted QC: 2020-05-14
• Study First Posted: 2020-05-19
• Study Start: 2020-08-01
• Status Verified: 2023-09
• Last Update Submitted: 2023-09-22
• Last Update Posted: 2023-09-26
• Primary Completion: 2024-01-01
• Study Completion: 2025-08-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Male
• Target Recruitment: 150

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
PSA Glycomics Assay	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.

Trial Locations

Locations (3)

Amsterdam UMC, location VUmc; 🇳🇱 Amsterdam, Netherlands

Amsterdam UMC, location AMC; 🇳🇱 Amsterdam, Noord Holland, Netherlands

Leiden University Medical Centre; 🇳🇱 Leiden, Netherlands