Micro-Ultrasound for Extracapsular Extension Detection in Prostate Cancer: A Multicenter Reader Study

Status

Recruiting

Phases

Unknown

Study type

Observational

Source

DRKS

Registry ID

DRKS00040733

Enrollment

Registered

2026-06-25

Start date

2026-01-01

Completion date

Unknown

Last updated

2026-08-03

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

Conditions

C61

Interventions

Group 1: Micro-ultrasound-based ECE assessment: Experienced urologists review transrectal mUS recordings (29 MHz ExactVu™ system) of prostate cancer patients for the presence of extraprostatic extensi

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Licensed physician, previous experience with transrectal micro-ultrasound (interpretation of at least 70 prostate micro-ultrasound scans), provision of written informed consent for participation in the study

Exclusion criteria

Exclusion criteria: Failure to meet one or more inclusion criteria

Design outcomes

Primary

Measure	Time frame
The primary endpoint is the diagnostic accuracy of micro-ultrasound-based extracapsular extension (ECE) assessment at the patient and side level, operationalized as the area under the receiver operating characteristic curve (AUC), sensitivity, specificity, positive and negative predictive value, and overall accuracy. Data are collected at a single time point upon completion of reader assessment, by comparing reader decisions against the histopathological reference standard derived from whole-mount radical prostatectomy specimens (pT2 = organ-confined disease, pT3 = extraprostatic extension), using a standardized electronic questionnaire.	—

Measure

Time frame

The primary endpoint is the diagnostic accuracy of micro-ultrasound-based extracapsular extension (ECE) assessment at the patient and side level, operationalized as the area under the receiver operating characteristic curve (AUC), sensitivity, specificity, positive and negative predictive value, and overall accuracy. Data are collected at a single time point upon completion of reader assessment, by comparing reader decisions against the histopathological reference standard derived from whole-mount radical prostatectomy specimens (pT2 = organ-confined disease, pT3 = extraprostatic extension), using a standardized electronic questionnaire.

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Secondary

Measure	Time frame
(1) inter-reader reliability at the patient and side level (Fleiss' kappa, pairwise Cohen's kappa); (2) morphologic ECE criteria discriminating true from false positive assessments (chi-square: capsular bulging, capsular disruption, irregular contour, long capsular contact length, seminal vesicle infiltration); (3) effect of reader experience on accuracy and agreement (senior urologists vs. residents); (4) reader calibration and decision confidence (Likert scales vs. histopathological outcome); (5) nerve-sparing recommendation vs. pathological findings (clinical simulation analysis); (6) impact of image quality on diagnostic correctness (logistic regression); (7) side-specific analysis of right vs. left prostatic lobe. All secondary endpoints are assessed upon completion of reader evaluation using the same standardized electronic questionnaire and histopathological reference standard as the primary endpoint.	—

Measure

Time frame

(1) inter-reader reliability at the patient and side level (Fleiss' kappa, pairwise Cohen's kappa); (2) morphologic ECE criteria discriminating true from false positive assessments (chi-square: capsular bulging, capsular disruption, irregular contour, long capsular contact length, seminal vesicle infiltration); (3) effect of reader experience on accuracy and agreement (senior urologists vs. residents); (4) reader calibration and decision confidence (Likert scales vs. histopathological outcome); (5) nerve-sparing recommendation vs. pathological findings (clinical simulation analysis); (6) impact of image quality on diagnostic correctness (logistic regression); (7) side-specific analysis of right vs. left prostatic lobe. All secondary endpoints are assessed upon completion of reader evaluation using the same standardized electronic questionnaire and histopathological reference standard as the primary endpoint.

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Countries

Germany

Contacts

Public ContactMaurin Helen Mangold

Universitätsklinikum Mannheim

maurinhelen.mangold@umm.de0621/3832201

Outcome results

None listed

Source: DRKS (via WHO ICTRP) · Data processed: Aug 10, 2026