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Retrospective, bicentric performance analysis of a prostate MRI reading AI solution compared to standard multiparametric MRI and histopathological results.

Retrospective, bicentric performance analysis of a prostate MRI reading AI solution compared to standard multiparametric MRI and histopathological results. - Prostate-AI

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
DRKS
Registry ID
DRKS00039810
Enrollment
120
Registered
2026-06-15
Start date
2026-07-01
Completion date
Unknown
Last updated
2026-06-22

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

Conditions

C61

Interventions

Group 1: For this project, we plan to analyse MRI data in total of 120 patients with mpMRI and subsequent targeted plus systematic biopsy from the different study sites (Düsseldorf and Herne). The dat

Sponsors

Universitätsklinikum Düsseldorf
Lead Sponsor

Eligibility

Sex/Gender
Male

Inclusion criteria

Inclusion criteria: • Consecutive patients who have received a multiparametric MRI examination at the different study sites and subsequent MRI targeted fusion biopsy. • PI-RADS 1-3 cases with negative systematic biopsy and/or cancer free follow-up

Exclusion criteria

Exclusion criteria: • Non-interpretable examinations (PI-QUAL 1). • Patients who have undergone surgery or radiotherapy for prostate cancer. • Discrepancies and incorrect MR report (filtered out by expert)

Design outcomes

Primary

MeasureTime frame
Primary endpoint is the diagnosis of clinically significant prostate cancers (csPC) (ISUP = 2) (PI-RADS =3) with histopathological results from consecutive biopsy as the gold standard.

Secondary

MeasureTime frame
Secondary endpoints are the number of diagnosed csPC compared to PI-RADS classification.

Countries

Germany

Contacts

Public ContactMatthias Boschheidgen

Universitätsklinikum Düsseldorf

matthias.boschheidgen@med.uni-duesseldorf.de+492118117752

Outcome results

None listed

Source: DRKS (via WHO ICTRP) · Data processed: Jun 29, 2026