Application of Ultrasound Radiomics in Ultrasound Fusion Targeted Prostate Biopsy
NCT ID: NCT05761912
Last Updated: 2026-01-22
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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ACTIVE_NOT_RECRUITING
464 participants
OBSERVATIONAL
2025-06-23
2026-02-15
Brief Summary
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Detailed Description
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Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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Ultrasound fusion targeted biopsy
Prostate ultrasound had abnormal echo and radiomics analysis showed high scores
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
No interventions assigned to this group
Interventions
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Targeted biopsy
For the high-risk targets identified by the radiomics model, perform targeted biopsy under ultrasound fusion.
Eligibility Criteria
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Inclusion Criteria
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
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
55 Years
MALE
No
Sponsors
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Wu Jieping Medical Foundation
OTHER
Shanghai Municipal Commission of Health and Family Planning
OTHER
Shanghai Minhang Central Hospital
OTHER
Responsible Party
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Chang He
Associate Clinical Professor
Principal Investigators
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Jiaqi Huang
Role: PRINCIPAL_INVESTIGATOR
Minhang Hospital, Fudan University
Locations
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170th Xinsong Rd, Minhang District
Shanghai, , China
Countries
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Other Identifiers
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Prostate Radiomics-1027
Identifier Type: -
Identifier Source: org_study_id
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