Skip to content

Establishment of an ultrasound evaluation method for the PI-RADS score of prostate cancer

Development of an ultrasound evaluation method for PI-RADS scoring of prostate cancer and a comparative study of the diagnostic efficacy of multi-parametric magnetic resonance imaging PI-RADS scoring

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR2400082813
Enrollment
Unknown
Registered
2024-04-09
Start date
2022-01-17
Completion date
Unknown
Last updated
2024-04-15

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:Ultrasound-guided trans-perineal prostate biopsy with 10+ X strips of tissue for pathological examination.
Index test:PCa ultrasound imaging histological scoring model
diagnostic efficacy of the PI-RADS score in multiparametric magnetic resonance imaging

Sponsors

Department of Ultrasound,Affiliated Hospital of North Sichuan Medical College
Lead Sponsor

Eligibility

Sex/Gender
Male
Age
40 Years to 90 Years

Inclusion criteria

Inclusion criteria: Inclusion criteria: ?Prostate specific antigen (PSA) > 4.0ng/ml, tPSA > 10ug/L or 4ug/L < tP-SA < 10ug/L, fPSA/tPSA < 0.16); ?Nodules found on rectal examination; ?Prostate hypoechoic nodules found on ultrasound or abnormal signal found on MRI; at least one of the above three abnormalities.

Exclusion criteria

Exclusion criteria: Exclusion criteria: (i) acute phase of urinary tract infection; (ii) postoperative endocrine or surgical treatment; (iii) diffuse prostatic lesions; (iv) presence of contraindications to the use of sulphur hexafluoride microbubbles (SonoVue); (v) severe cardiovascular complications: hypertensive crisis, decompensated heart failure; (vi) severe internal and external haemorrhoids and perianal or rectal lesions; (vii) diseases with a serious bleeding tendency; (viii) diabetes mellitus with unstable blood glucose.

Design outcomes

Primary

MeasureTime frame
ultrasound;total-PSA,free-PSA,f/t PSA;mp-MRI;Area under ROC curve;

Secondary

MeasureTime frame
sensitivity;specificity;positive predictive value;negative predictive value;

Countries

China

Contacts

Public ContactWensheng Yue

Department of Ultrasound, Affiliated Hospital of North Sichuan Medical College

wensheng-yue@163.com+86 139 9076 7960

Outcome results

None listed

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