Clinical trial NCT03565289: PRospective Prostate biOmarker Study
Official title: PRospective Prostate biOmarker Study (PROPOSe)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Indication for Prostate Biopsy Due to Suspected Prostate Cancer
Lead sponsor: ProteoMediX AG
Sponsor class: INDUSTRY
First posted: 2018-06-21
Enrollment: 455
Sex: MALE
Minimum age (years): 45
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with an indication for prostate biopsy at the participating sites.

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.

Eligibility criteria: 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.)

Primary outcomes:
measure: Diagnosis of PCA
timeFrame: 6 months
measure: Aggressiveness of PCA
timeFrame: 6 months
measure: Diagnosis of PCA
timeFrame: 12 months
measure: Aggressiveness of PCA
timeFrame: 12 months
Secondary outcomes:
Other outcomes:
measure: Glycoprotein panel algorithm
timeFrame: After 12 months
measure: Additional Biomarkers
timeFrame: After 12 months
Locations:
city: Linz
country: Austria
facility: Ordensklinikum Linz
state: Oberösterreich
city: Innsbruck
country: Austria
facility: Medizinische Universität Innsbruck
city: Copenhagen
country: Denmark
facility: Rigshospitalet
city: Münster
country: Germany
facility: Universitätsklinikum Münster
state: NRW
city: Bad Saarow
country: Germany
facility: Helios Klinikum Bad Saarow
city: Bonn
country: Germany
facility: Malteser Krankenhaus Bonn/Rhein-Sieg
city: Braunschweig
country: Germany
facility: Städtisches Klinikum Braunschweig gGmbH
city: Frankfurt
country: Germany
facility: Universitätsklinikum Frankfurt
city: Hamburg
country: Germany
facility: Martini Klinik am UKE GmbH
city: Herne
country: Germany
facility: Marien-Hospital Herne
city: Stuttgart
country: Germany
facility: Daikonie Klinikum Stuttgart
Study officials:
affiliation: Martiniklinik am UKE gGmbH
name: Thomas Steuber, Prof. Dr.
role: PRINCIPAL_INVESTIGATOR
References: