Prostate Cancer Clinical Trial
Official title:
Evaluation of Prostate-Specific Antigen Glycomics Assay for the Early Detection of Prostate Cancer
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.
| 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. |
| Country | Name | City | State |
|---|---|---|---|
| Netherlands | Amsterdam UMC, location AMC | Amsterdam | Noord Holland |
| Netherlands | Amsterdam UMC, location VUmc | Amsterdam | |
| Netherlands | Leiden University Medical Centre | Leiden |
| Lead Sponsor | Collaborator |
|---|---|
| Prof.dr. H.P. Beerlage | Amsterdam UMC, location VUmc, Leiden University Medical Center, Radboud University Medical Center, The Netherlands Cancer Institute |
Netherlands,
| 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 |
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