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POET Trial - PrOspective Evaluation of a new Perilesional Template for Systematic Prostate Biopsy

POET Trial - PrOspective Evaluation of a new Perilesional Template for Systematic Prostate Biopsy - POET

Status
Recruiting
Phases
Early Phase 1
Study type
Interventional
Source
DRKS
Registry ID
DRKS00031670
Enrollment
156
Registered
2023-04-14
Start date
2023-04-08
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

R77.80

Interventions

Group 1: Prostatebiopsy with a combination of MRI-targeted biopsy + synchronous systematic biopsy according to a sectoral (SSB) AND perilesional template (PLT)

Sponsors

Universitätsklinikum Freiburg, Klinik für Urologie
Lead Sponsor

Eligibility

Sex/Gender
Male
Age
18 Years to No maximum

Inclusion criteria

Inclusion criteria: - Men with indication for prostate biopsy and presence of an MRI-suspected lesion (PI-RADS > 3) - Age > 18 years - Presence of a written informed consent

Exclusion criteria

Exclusion criteria: - Very large index lesion suspicious for MRI (diameter > 40mm). - Previously diagnosed prostate carcinoma - Previous surgical therapy of the prostate (also due to a benign prostatic hyperplasia) - Anatomic abnormalities that preclude perineal biopsy of the prostate according to routine clinical practice

Design outcomes

Primary

MeasureTime frame
- cancer detection rate of significant prostate cancer with the respective biopsy method (patient-level) - cancer detection rate of indolent prostate cancer with the respective biopsy method (patient-level)

Secondary

MeasureTime frame
- Cancer detection rates at lesion level. - Comparison of the number of biopsy cores (SSB vs. PLT) - Comparison of the percentage of cancerous cores (SSB vs. PLT) - Prospective evaluation of complications and functional aspects after perineal prostate biopsy

Countries

Germany

Contacts

Public ContactAugust Sigle

Uniklinik Freiburg Klinik für Uroloogie

august.sigle@uniklinik-freiburg.de+49 761 270 28930

Outcome results

None listed

Source: DRKS (via WHO ICTRP) · Data processed: Feb 4, 2026