Application of Ultrasound Radiomics in Ultrasound Fusion Targeted Prostate Biopsy

To predict prostate cancer by ultrasound radiomics in ultrasound fusion prostate targeted biopsy.

Study Overview

• Status: Active, not recruiting
• Conditions: Prostate Cancer; Ultrasound; Radiomics
• Intervention / Treatment: Diagnostic test: Targeted biopsy

Detailed Description

Researchers plan to develop a diagnostic and prognostic evaluation model for prostate cancer by analyzing abnormal echoes in prostate ultrasound images through radiomics. This model will be used to guide ultrasound radiomics-fusion prostate biopsy, and its accuracy will be compared with that of systematic biopsy.

• Study Type: Observational
• Enrollment (Estimated): 464

Contacts and Locations

Study Locations

• China
  • Shanghai, China
    • 170th Xinsong Rd, Minhang District

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 55 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Probability Sample

Study Population

Patients aged above 55 who had an indication for prostate biopsy will be screened for eligibility.

Description

Inclusion Criteria:

1. Age ≥55 years old.
2. Patients had tPSA/fPSA within 1 month before biopsy.

3. Patients had any of the following indications for prostate biopsy:

   • Suspicious prostate nodules were found by digital rectal examination
   • Suspicious lesions were detected by B-ultrasound or MRI
   • PSA>10ng/ml
   • PSA 4-10ng/ml, with abnormal f/tPSA and/or PSAD values

Exclusion Criteria:

1. malignant tumors other than prostate adenocarcinoma indicated by pathology.
2. Combined with other malignant tumors (such as rectal cancer, bladder cancer, testicular cancer, etc.) that may affect the imaging findings of transrectal ultrasound or mpMRI.
3. Other conditions that would preclude needle biopsy: cachexia, decompensation of organ function, hemorrhagic diseases, local infection, etc

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Ultrasound fusion targeted biopsy; Prostate ultrasound had abnormal echo and radiomics analysis showed high scores	Diagnostic test: Targeted biopsy; For the high-risk targets identified by the radiomics model, perform targeted biopsy under ultrasound fusion.
Systematic biopsy; Patients meeting the indications for prostate biopsy

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Positive rate of ultrasound radiomics fusion targeted biopsy	Positive rate of ultrasound radiomics fusion targeted biopsy	Up to seventh day when the pathological results were obtained after the targeted biopsy
Positive rate of mpMRI cognitive fusion targeted biopsy	Positive rate of mpMRI cognitive fusion targeted biopsy	Up to seventh day when the pathological results were obtained after the targeted biopsy
Positive rate of systematic biopsy	Positive rate of systematic biopsy	Up to seventh day when the pathological results were obtained after the targeted biopsy
Ultrasound radiomics parameters	The ultrasound images are obtained by transrectal ultrasound while prostate biopsy. Then investigators use 3D-Slicer/ITK-SNAP software to draw the area of interest (ROI). "Pyradiomics" library will be used to extract the radiomics features.	The 30min following the transrectal ultrasonography

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Gleason's score of positive tissue	Gleason's score of positive tissue from targeted prostate biopsy. Prostate cancer was graded by Gleason score (GS) ranging from 6 to 10. Tumors of GS 6 (3 + 3) are considered low grade (LG), while GS ≥7 are high grade (HG).	Up to seventh day when the pathological results were obtained after the targeted biopsy
PI-RADS score	Prostate Imaging Reporting and Data System (PI-RADS) score was obtained according to multiparametric magnetic resonance imaging. PI-RADS is used to standardize interpretation of prostate MRI. Each lesion is assigned a score from 1 to 5 indicating the likelihood of clinically significant cancer. PI-RADS 1: clinically significant cancer is highly unlikely to be present; PI-RADS 2: clinically significant cancer is unlikely to be present; PI-RADS 3: the presence of clinically significant cancer is equivocal; PI-RADS 4: clinically significant cancer is likely to be present; PI-RADS 5: clinically significant cancer is highly likely to be present.	Within one month prior to prostate biopsy.
Incidence of complications	Incidence of complications associated with prostate biopsy	Up to the first month after the targeted biopsy

Collaborators and Investigators

• Sponsor: Shanghai Minhang Central Hospital
• Collaborators: Wu Jieping Medical Foundation; Shanghai Municipal Commission of Health and Family Planning
• Investigators: Principal Investigator: Jiaqi Huang, Minhang Hospital, Fudan University

Study record dates

Study Major Dates

• Study Start (Actual): June 23, 2025
• Primary Completion (Estimated): February 15, 2026
• Study Completion (Estimated): February 15, 2026

Study Registration Dates

• First Submitted: December 18, 2022
• First Submitted That Met QC Criteria: February 27, 2023
• First Posted (Actual): March 9, 2023

Study Record Updates

• Last Update Posted (Actual): January 22, 2026
• Last Update Submitted That Met QC Criteria: January 20, 2026
• Last Verified: July 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Urogenital Diseases; Genital Diseases; Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Prostatic Diseases; Male Urogenital Diseases; Prostatic Neoplasms
• Other Study ID Numbers: Prostate Radiomics-1027

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No