NCT04393376RecruitingNot Applicable
Evaluation of Prostate-Specific Antigen Glycomics Assay for the Early Detection of Prostate Cancer
Prof.dr. H.P. Beerlage4 sites in 1 country150 target enrollmentStarted: August 1, 2020Last updated:
Conditions
Trial Snapshot
- Phase
- Not Applicable
- Status
- Recruiting
- Sponsor
- Enrollment
- 150
- Locations
- 4
- Primary Endpoint
- PSA Glycomics Assay
Study 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.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Diagnostic
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- Male
- Accepts 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.
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.
Secondary Outcomes
No secondary outcomes reported
Investigators
Prof.dr. H.P. Beerlage
Urologist, Head of Department of Urology
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
Study Sites (4)
Loading locations...
Similar Trials
Recruiting
Not Applicable
Evaluation of Prostate-Specific Antigen Glycomics Assay for the Early Detection of Prostate CancerProstate CancerNL-OMON49657Amsterdam UMC225
Recruiting
Not Applicable
Determination of Prostate-specific Antigen in Capillary Blood (PSA-Cap)Prostate CancerNCT06626386Heinrich-Heine University, Duesseldorf200
Recruiting
Phase 2
Evaluation of PSMA in HER2- AR+ Metastatic Breast CancerHER2-negative Breast CancerMetastatic Breast CancerBreast CancerNCT04573231University of Wisconsin, Madison13
Unknown
Phase 1
Peptide-specific Vaccination in HLA-A*02 Positive Patients With Biochemical Recurrence After Radical ProstatectomyRecurrent Prostate CancerNCT02452307University Hospital Tuebingen36
Completed
Not Applicable
Evaluation of Molecular Forms of PSA and Human Kallikrein 2 in a Cohort of Patients With Locally Resected Prostate Cancer But Biochemical RecurrenceProstate CancerNCT02070575Memorial Sloan Kettering Cancer Center200