PRospective Prostate biOmarker Study

Indication for Prostate Biopsy Due to Suspected Prostate Cancer Clinical Trial

— PROPOSe  

Official title:

PRospective Prostate biOmarker Study (PROPOSe)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03565289
• Other study ID #: PROPOSe_1
• Status: Completed
• Start date: August 14, 2018
• Est. completion date: January 31, 2020

Study information

• Verified date: December 2020
• Source: ProteoMediX AG
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

• Correlation of a glycoprotein panel with prostate biopsy outcome and PCa aggressiveness

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 455
• Est. completion date: January 31, 2020
• Est. primary completion date: December 31, 2019
• 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.)

Related Conditions & MeSH terms

• Indication for Prostate Biopsy Due to Suspected Prostate Cancer
• Prostatic Neoplasms

Intervention

Diagnostic Test:
• Blood sample collection
During a routine blood draw an additional tube of blood will be taken for the study.

Locations

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

Sponsors (1)

Lead Sponsor	Collaborator
ProteoMediX AG

Countries where clinical trial is conducted

Austria,  Denmark,  Germany, 

Outcome

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