PRospective Prostate biOmarker Study

NCT03565289 | Completed

• 1 other identifier: PROPOSe_1
• Study Type: observational
• Target: 455
• Locations: 3 countries
• Sites: 11

Brief Summary

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

Conditions

Indication for Prostate Biopsy Due to Suspected Prostate Cancer

Outcome Measures

Primary Outcomes (4)

• 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 Outcomes (2)

• Glycoprotein panel algorithm

  After 12 months

• Additional Biomarkers

  After 12 months

Study Arms (1)

All patients

All

Diagnostic Test: Blood sample collection

Interventions

Blood sample collection DIAGNOSTIC_TEST

During a routine blood draw an additional tube of blood will be taken for the study.

All patients

Eligibility Criteria

• Age: 45 Years - 80 Years
• Sex: male
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• 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

You may not qualify if:

• 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.)

Sponsors & Collaborators

• ProteoMediX AG: lead

Study Sites (11)

Ordensklinikum Linz

Linz, Upper Austria, 6020, Austria

Location

Medizinische Universität Innsbruck

Innsbruck, 6020, Austria

Location

Rigshospitalet

Copenhagen, 2200, Denmark

Location

Universitätsklinikum Münster

Münster, North Rhine-Westphalia, 48149, Germany

Location

Helios Klinikum Bad Saarow

Bad Saarow, 15526, Germany

Location

Malteser Krankenhaus Bonn/Rhein-Sieg

Bonn, 53123, Germany

Location

Städtisches Klinikum Braunschweig gGmbH

Braunschweig, 38126, Germany

Location

Universitätsklinikum Frankfurt

Frankfurt, 60590, Germany

Location

Martini Klinik am UKE GmbH

Hamburg, 20246, Germany

Location

Marien-Hospital Herne

Herne, 44625, Germany

Location

Daikonie Klinikum Stuttgart

Stuttgart, 70176, Germany

Location

Biospecimen

Retention: SAMPLES WITH DNA

Blood samples

Study Officials

• Thomas Steuber, Prof. Dr.

  Martiniklinik am UKE gGmbH

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 7, 2018
• First Posted: June 21, 2018
• Study Start: August 14, 2018
• Primary Completion: December 31, 2019
• Study Completion: January 31, 2020
• Last Updated: December 16, 2020

Record last verified: 2020-12

Data Sharing

• IPD Sharing: Will not share

Locations

AU (2); DK (1); DE (8)