Application of Ultrasound Radiomics in Ultrasound Fusion Targeted Prostate Biopsy

NCT05761912 | Active Not Recruiting

• 1 other identifier: Prostate Radiomics-1027
• Study Type: observational
• Target: 464
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Prostate Cancer; Ultrasound; Radiomics

Outcome Measures

Primary Outcomes (4)

• 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 systematic biopsy

  Positive rate of systematic 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

• 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 Outcomes (3)

• Gleason's score of positive tissue

  Up to seventh day when the pathological results were obtained after the targeted biopsy

• PI-RADS score

  Within one month prior to prostate biopsy.

• Incidence of complications

  Up to the first month after the targeted biopsy

Study Arms (2)

Ultrasound fusion targeted biopsy

Prostate ultrasound had abnormal echo and radiomics analysis showed high scores

Diagnostic Test: Targeted biopsy

Systematic biopsy

Patients meeting the indications for prostate biopsy

Interventions

Targeted biopsy DIAGNOSTIC_TEST

For the high-risk targets identified by the radiomics model, perform targeted biopsy under ultrasound fusion.

Ultrasound fusion targeted biopsy

Eligibility Criteria

• Age: 55 Years+
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

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

You may qualify if:

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

You may not qualify if:

• malignant tumors other than prostate adenocarcinoma indicated by pathology.
• 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.
• Other conditions that would preclude needle biopsy: cachexia, decompensation of organ function, hemorrhagic diseases, local infection, etc

Sponsors & Collaborators

• Shanghai Minhang Central Hospital: lead
• Wu Jieping Medical Foundation: collaborator
• Shanghai Municipal Commission of Health and Family Planning: collaborator

Study Sites (1)

170th Xinsong Rd, Minhang District

Shanghai, China

Location

MeSH Terms

Conditions

Prostatic Neoplasms

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases

Study Officials

• Jiaqi Huang

  Minhang Hospital, Fudan University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Clinical Professor

Study Record Dates

• First Submitted: December 18, 2022
• First Posted: March 9, 2023
• Study Start: June 23, 2025
• Primary Completion: February 15, 2026
• Study Completion: February 15, 2026
• Last Updated: January 22, 2026

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)