Indication for Prostate Biopsy Due to Suspected Prostate Cancer Clinical Trial
— PROPOSeOfficial title:
PRospective Prostate biOmarker Study (PROPOSe)
NCT number | NCT03565289 |
Other study ID # | PROPOSe_1 |
Secondary ID | |
Status | Completed |
Phase | |
First received | |
Last updated | |
Start date | August 14, 2018 |
Est. completion date | January 31, 2020 |
Verified date | December 2020 |
Source | ProteoMediX AG |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
• Correlation of a glycoprotein panel with prostate biopsy outcome and PCa aggressiveness
Status | Completed |
Enrollment | 455 |
Est. completion date | January 31, 2020 |
Est. primary completion date | December 31, 2019 |
Accepts healthy volunteers | |
Gender | Male |
Age group | 45 Years to 80 Years |
Eligibility | 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.) |
Country | Name | City | State |
---|---|---|---|
Austria | Medizinische Universität Innsbruck | Innsbruck | |
Austria | Ordensklinikum Linz | Linz | Oberösterreich |
Denmark | Rigshospitalet | Copenhagen | |
Germany | Helios Klinikum Bad Saarow | Bad Saarow | |
Germany | Malteser Krankenhaus Bonn/Rhein-Sieg | Bonn | |
Germany | Städtisches Klinikum Braunschweig gGmbH | Braunschweig | |
Germany | Universitätsklinikum Frankfurt | Frankfurt | |
Germany | Martini Klinik am UKE GmbH | Hamburg | |
Germany | Marien-Hospital Herne | Herne | |
Germany | Universitätsklinikum Münster | Münster | NRW |
Germany | Daikonie Klinikum Stuttgart | Stuttgart |
Lead Sponsor | Collaborator |
---|---|
ProteoMediX AG |
Austria, Denmark, Germany,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | Glycoprotein panel algorithm | Refinement of the glycoprotein panel algorithm | After 12 months | |
Other | Additional Biomarkers | 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 | After 12 months | |
Primary | Diagnosis of PCA | Correlation of the glycoprotein panel algorithm with histological diagnosis of PCa | 6 months | |
Primary | Aggressiveness of PCA | Correlation of the glycoprotein panel algorithm with diagnosis of significant (Gleason Score =7) PCa | 6 months | |
Primary | Diagnosis of PCA | Correlation of the glycoprotein panel algorithm with histological diagnosis of PCa | 12 months | |
Primary | Aggressiveness of PCA | Correlation of the glycoprotein panel algorithm with diagnosis of significant (Gleason Score =7) PCa | 12 months |