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)
Facility
City
Region
Status
170th Xinsong Rd, Minhang District
Shanghai
China
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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.
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