Application of Ultrasound Radiomics in Ultrasound Fusion Targeted Prostate Biopsy

NCT ID: NCT05761912

Last Updated: 2026-01-22

Study Results

Results pending

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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Recruitment Status

ACTIVE_NOT_RECRUITING

Total Enrollment

464 participants

Study Classification

OBSERVATIONAL

Study Start Date

2025-06-23

Study Completion Date

2026-02-15

Brief Summary

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

Detailed Description

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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.

Conditions

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Prostate Cancer Ultrasound Radiomics

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Ultrasound fusion targeted biopsy

Prostate ultrasound had abnormal echo and radiomics analysis showed high scores

Targeted biopsy

Intervention Type DIAGNOSTIC_TEST

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.

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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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
Minimum Eligible Age

55 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

No

Sponsors

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Wu Jieping Medical Foundation

OTHER

Sponsor Role collaborator

Shanghai Municipal Commission of Health and Family Planning

OTHER

Sponsor Role collaborator

Shanghai Minhang Central Hospital

OTHER

Sponsor Role lead

Responsible Party

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Chang He

Associate Clinical Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

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

Site Status

Countries

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China

Other Identifiers

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Prostate Radiomics-1027

Identifier Type: -

Identifier Source: org_study_id

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