Indication for Prostate Biopsy Due to Suspected Prostate Cancer
Conditions
Brief summary
• Correlation of a glycoprotein panel with prostate biopsy outcome and PCa aggressiveness
Detailed description
The main objective of this study is to correlate a glycoprotein panel with prostate biopsy outcome, i.e. distinguishing PCa from benign prostatic conditions as well as high-grade cancer. The quantities of the two protein analytes cathepsin D (CTSD) and thrombospondin 1 (THBS1) are measured in human serum samples. In combination with percent free PSA (%fPSA), the results are correlated with prostate biopsy outcome. The potential future benefit of using this glycoprotein panel is to validate positive tPSA tests in men with negative digital rectal examination (DRE) and enlarged prostates to reduce the need for undergoing a biopsy, thereby reducing unnecessary biopsies and potentially predicting high-grade disease.
Interventions
DIAGNOSTIC_TESTBlood sample collection
During a routine blood draw an additional tube of blood will be taken for the study.
Sponsors
ProteoMediX AG
Study design
Observational model
CASE_ONLY
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
MALE
Age
45 Years to 80 Years
Inclusion criteria
* Male patient between 45 and 80 years old. * tPSA between 2 and 10 ng/ml * Prostate volume \>=35 ml * Non-suspicious DRE for prostate cancer * Scheduled for prostate biopsy * Patient must give written informed consent
Exclusion criteria
* Patient not undergoing biopsy of the prostate * Prior prostate biopsy within the last 12 months * Transurethral resection of the prostate (TURP) in the last 5 years * Patients with known acute or chronic prostatitis/cystitis or other known prostate abnormalities * Patient taking 5-alpha-reductase inhibitor * Any other prior treatment of the prostate (cryoablation, hifu, ire, radiation therapy, alcohol instillation, etc.)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Diagnosis of PCA | 6 months | Correlation of the glycoprotein panel algorithm with histological diagnosis of PCa |
| Aggressiveness of PCA | 6 months | Correlation of the glycoprotein panel algorithm with diagnosis of significant (Gleason Score ≥7) PCa |
Other
| Measure | Time frame | Description |
|---|---|---|
| Glycoprotein panel algorithm | After 12 months | Refinement of the glycoprotein panel algorithm |
| Additional Biomarkers | After 12 months | Correlation of additional biomarkers (e. g. olfactomedin 4 (OLFM4), intercellular adhesion molecule 1 (ICAM1), hypoxia up-regulated protein 1(HYOU1) and metallopeptidase inhibitor 1 (TIMP1)) with histological diagnosis of PCa |
Countries
Austria, Denmark, Germany
Outcome results
None listed