Evaluation of One-Step Nucleic Acid Amplification (OSNA) for molecular detection of lymph node metastases in patients with prostate cancer

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

DRKS

Registry ID

DRKS00011401

Enrollment

Registered

2017-04-06

Start date

2017-04-27

Completion date

Unknown

Last updated

2025-04-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

C61

Interventions

Group 1: Patients with intermediate or high risk prostate cancer (PSA >10 ng/ml and/or Gleason score =7) scheduled for open radical retropubic prostatectomy with magnetometer (SentiMag)-guided sentine

Eligibility

Sex/Gender

Male

Age

18 Years to No maximum

Inclusion criteria

Inclusion criteria: Patients with intermediate or high risk prostate cancer (PSA >10 ng/ml and/or Gleason score =7) scheduled for open radical retropubic prostatectomy with sentinel lymph node dissection and extended lymph node dissection

Exclusion criteria

Exclusion criteria: Patients unable to consent

Design outcomes

Primary

Measure	Time frame
Determination of sensitivity and specifity of the OSNA assay in detection of lymph node metastases in prostate cancer compared to conventional histopathology and immunohistochemistry	—

Secondary

Measure	Time frame
Determination of concordance rate between the OSNA assay, conventional histopathology and immunohistochemistry concerning the detection of lymph node metatstases as well as the ability to differentiate beween macro- and micrometastases	—

Countries

Germany

Contacts

Public ContactAlexander Winter

Universitätsklinik für Urologie, Klinikum Oldenburg, Fakultät für Medizin und Gesundheitswissenschaften, Carl von Ossietzky Universität Oldenburg

winter.alexander@klinikum-oldenburg.de04414032302

Outcome results

None listed

Source: DRKS (via WHO ICTRP) · Data processed: Feb 21, 2026