Management of prostate indeterminate lesions on magnetic resonance imaging(PIRADS 3): a multicenter cohort study

Status

Active, not recruiting

Phases

Early Phase 1

Study type

Observational

Source

ChiCTR

Registry ID

ChiCTR2300075492

Enrollment

Unknown

Registered

2023-09-06

Start date

2023-09-15

Completion date

Unknown

Last updated

2023-09-11

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

Conditions

prostate cancer

Interventions

Gold Standard:TRUS guided prostate systematic and targeted biopsy

Index test:The stratification model combine multiparametric MRI radiomic and clinical factors to predictive the clinical significant prostate cancer in PI-RADS 3 lesions.

Eligibility

Sex/Gender

All

Age

18 Years to 85 Years

Inclusion criteria

Inclusion criteria: ?MRI images were assigned PI-RADS V2.1 score 3 by two genitourinary radiologists experienced in urological diagnosis; ?All identified patients underwent targeted TRUS guided prostate biopsy within 3 months; ?The image quality of prostate multiparametric MRI meet the requirement of radiomics analysis; ?Complete clinical data.

Exclusion criteria

Exclusion criteria: ?Poor image quality; ?PI-RADS 1–2, PI-RADS 4–5, or PI-RADS 3 coexisted with other types of lesions; ?intervention prior to MRI examination, such as biopsy, surgery, or hormone therapy; ?incomplete clinical data.

Design outcomes

Primary

Measure	Time frame
prostate multiparametric MRI (T2WI+DWI/ADC+DCE) radiomic model;Accuracy;Sensitivity ;Specificity ;	—

Secondary

Measure	Time frame
prostate-specific antigen;prostate volume;prostate-specific antigen density;age;lesion location;lesion size;	—

Countries

China

Contacts

Public ContactQin Naishan

Peking University First Hospital

docqin730@sina.com+86 139 1067 0368

Outcome results

None listed

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