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Clinical Trials in China / NCT05761912
Active, not recruiting Observational

Application of Ultrasound Radiomics in Ultrasound Fusion Targeted Prostate Biopsy

NCT05761912 · tracked via the Priya Life Science China tracker
Sponsor
Shanghai Minhang Central Hospital
Phase
Observational
Started
2025-06-23
Last updated
2026-10-06

Condition(s) studied

Prostate CancerUltrasoundRadiomics

Investigational drug(s) / intervention(s)

Targeted biopsy

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

Study summary

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

Eligibility

Sex
MALE
Min age
55 Years
Max age
—
Healthy volunteers
No
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

Primary outcome measure(s)

  • 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 ultrasound radiomics fusion targeted biopsy
  • Positive rate of systematic biopsy — Up to seventh day when the pathological results were obtained after the targeted biopsy
    Positive rate of systematic 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 mpMRI cognitive fusion targeted biopsy
  • Ultrasound radiomics parameters — The 30min following the transrectal ultrasonography
    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.

Trial sites (1)

FacilityCityRegionStatus
170th Xinsong Rd, Minhang District Shanghai China

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT05761912 on ClinicalTrials.gov ↗ ← All trials in China