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PROPOSe: PRospective Prostate biOmarker Study

Sponsor
ProteoMediX AG (Industry)
Overall Status
Completed
CT.gov ID
NCT03565289
Collaborator
(none)
455
Enrollment
11
Locations
17.6
Actual Duration (Months)
41.4
Patients Per Site
2.4
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease Intervention/Treatment Phase
  • 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 Design

Study Type:
Observational
Actual Enrollment :
455 participants
Observational Model:
Case-Only
Time Perspective:
Prospective
Official Title:
PRospective Prostate biOmarker Study (PROPOSe)
Actual Study Start Date :
Aug 14, 2018
Actual Primary Completion Date :
Dec 31, 2019
Actual Study Completion Date :
Jan 31, 2020

Arms and Interventions

Arm 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.

Outcome Measures

Primary Outcome Measures

  1. Diagnosis of PCA [6 months]

    Correlation of the glycoprotein panel algorithm with histological diagnosis of PCa

  2. Aggressiveness of PCA [6 months]

    Correlation of the glycoprotein panel algorithm with diagnosis of significant (Gleason Score ≥7) PCa

  3. Diagnosis of PCA [12 months]

    Correlation of the glycoprotein panel algorithm with histological diagnosis of PCa

  4. Aggressiveness of PCA [12 months]

    Correlation of the glycoprotein panel algorithm with diagnosis of significant (Gleason Score ≥7) PCa

Other Outcome Measures

  1. Glycoprotein panel algorithm [After 12 months]

    Refinement of the glycoprotein panel algorithm

  2. 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

Eligibility Criteria

Criteria

Ages Eligible for Study:
45 Years to 80 Years
Sexes Eligible for Study:
Male
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.)

Contacts and Locations

Locations

Site City State Country Postal Code
1 Ordensklinikum Linz Linz Oberösterreich Austria 6020
2 Medizinische Universität Innsbruck Innsbruck Austria 6020
3 Rigshospitalet Copenhagen Denmark 2200
4 Universitätsklinikum Münster Münster NRW Germany 48149
5 Helios Klinikum Bad Saarow Bad Saarow Germany 15526
6 Malteser Krankenhaus Bonn/Rhein-Sieg Bonn Germany 53123
7 Städtisches Klinikum Braunschweig gGmbH Braunschweig Germany 38126
8 Universitätsklinikum Frankfurt Frankfurt Germany 60590
9 Martini Klinik am UKE GmbH Hamburg Germany 20246
10 Marien-Hospital Herne Herne Germany 44625
11 Daikonie Klinikum Stuttgart Stuttgart Germany 70176

Sponsors and Collaborators

  • ProteoMediX AG

Investigators

  • Principal Investigator: Thomas Steuber, Prof. Dr., Martiniklinik am UKE gGmbH

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
ProteoMediX AG
ClinicalTrials.gov Identifier:
NCT03565289
Other Study ID Numbers:
  • PROPOSe_1
First Posted:
Jun 21, 2018
Last Update Posted:
Dec 16, 2020
Last Verified:
Dec 1, 2020
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:
Prostatic Neoplasms

Study Results

No Results Posted as of Dec 16, 2020