Testing a new urine and serum test for early detection of prostate cancer
Evaluation of Prostate-Specific Antigen Glycomics Assay for the Early Detection of Prostate Cancer
This study is testing a new urine and blood test to see if it can help find prostate cancer earlier in men who have high PSA levels.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 150 (estimated) |
| Ages | 18 Years and up |
| Sex | Male |
| Sponsor | Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA) Academic / other |
| Drugs / interventions | chemotherapy |
| Locations | 3 sites (Amsterdam, Noord Holland and 2 other locations) |
| Trial ID | NCT04393376 on ClinicalTrials.gov |
What this trial studies
This pilot study aims to evaluate the PSA Glycomics Assay using urine and serum samples to determine its effectiveness in identifying prostate cancer in patients with elevated PSA levels. The study will assess whether this assay can provide insights into the disease state and aggressiveness of prostate cancer. By analyzing the glycomic profiles associated with PSA, researchers hope to improve early detection and characterization of prostate cancer. Participants will be required to provide informed consent and meet specific eligibility criteria.
Who should consider this trial
Good fit: Ideal candidates include men with elevated PSA levels greater than 3 ng/mL who have provided informed consent.
Not a fit: Patients with bladder infections, those undergoing chemotherapy, or individuals using 5-alpha reductase inhibitors will not benefit from this study.
Why it matters
Potential benefit: If successful, this assay could lead to earlier and more accurate detection of prostate cancer, potentially improving patient outcomes.
How similar studies have performed: Other studies have explored glycomics in cancer detection, but this specific approach is relatively novel and untested.
Eligibility criteria
Show full inclusion / exclusion criteria
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.
Where this trial is running
Amsterdam, Noord Holland and 2 other locations
- Amsterdam UMC, location AMC — Amsterdam, Noord Holland, Netherlands (Completed)
- Amsterdam UMC, location VUmc — Amsterdam, Netherlands (Recruiting)
- Leiden University Medical Centre — Leiden, Netherlands (Recruiting)
Study contacts
- Study coordinator: J R Oddens, MD, PhD
- Email: j.r.oddens@amsterdamumc.nl
- Phone: +31(0)20-5668637
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.