PRospective Prostate biOmarker Study (PROPOSe)

PRospective Prostate biOmarker Study (PROPOSe)

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

Study Overview

• Status: Completed
• Conditions: Indication for Prostate Biopsy Due to Suspected Prostate Cancer
• Intervention / Treatment: Diagnostic test: Blood sample collection

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.

• Study Type: Observational
• Enrollment (Actual): 455

Contacts and Locations

Study Locations

• Austria
  • Innsbruck, Austria, 6020
    • Medizinische Universität Innsbruck
  • Oberösterreich
    • Linz, Oberösterreich, Austria, 6020
      • Ordensklinikum Linz
• Denmark
  • Copenhagen, Denmark, 2200
    • Rigshospitalet
• Germany
  • Bad Saarow, Germany, 15526
    • HELIOS Klinikum Bad Saarow
  • Bonn, Germany, 53123
    • Malteser Krankenhaus Bonn/Rhein-Sieg
  • Braunschweig, Germany, 38126
    • Städtisches Klinikum Braunschweig gGmbH
  • Frankfurt, Germany, 60590
    • Universitatsklinikum Frankfurt
  • Hamburg, Germany, 20246
    • Martini Klinik am UKE GmbH
  • Herne, Germany, 44625
    • Marien-Hospital Herne
  • Stuttgart, Germany, 70176
    • Daikonie Klinikum Stuttgart
  • NRW
    • Münster, NRW, Germany, 48149
      • Universitatsklinikum Munster

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 45 years to 80 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: N/A
• Genders Eligible for Study: Male

• Sampling Method: Non-Probability Sample

Study Population

Patients with an indication for prostate biopsy at the participating sites.

Description

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.)

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
All patients; All	Diagnostic test: Blood sample collection; During a routine blood draw an additional tube of blood will be taken for the study.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Diagnosis of PCA	Correlation of the glycoprotein panel algorithm with histological diagnosis of PCa	6 months
Aggressiveness of PCA	Correlation of the glycoprotein panel algorithm with diagnosis of significant (Gleason Score ≥7) PCa	6 months
Diagnosis of PCA	Correlation of the glycoprotein panel algorithm with histological diagnosis of PCa	12 months
Aggressiveness of PCA	Correlation of the glycoprotein panel algorithm with diagnosis of significant (Gleason Score ≥7) PCa	12 months

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Glycoprotein panel algorithm	Refinement of the glycoprotein panel algorithm	After 12 months
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

Collaborators and Investigators

• Sponsor: ProteoMediX AG
• Investigators: Principal Investigator: Thomas Steuber, Prof. Dr., Martiniklinik am UKE gGmbH

Study record dates

Study Major Dates

• Study Start (ACTUAL): August 14, 2018
• Primary Completion (ACTUAL): December 31, 2019
• Study Completion (ACTUAL): January 31, 2020

Study Registration Dates

• First Submitted: June 7, 2018
• First Submitted That Met QC Criteria: June 20, 2018
• First Posted (ACTUAL): June 21, 2018

Study Record Updates

• Last Update Posted (ACTUAL): December 16, 2020
• Last Update Submitted That Met QC Criteria: December 14, 2020
• Last Verified: December 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Genital Neoplasms, Male; Prostatic Diseases; Prostatic Neoplasms
• Other Study ID Numbers: PROPOSe_1

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No