Application of Ultrasound Radiomics in Ultrasound Fusion Targeted Prostate Biopsy

N/AActive Not RecruitingNCT05761912

Shanghai Minhang Central Hospital464 enrolled

Overview

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

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.

Study Type

OBSERVATIONAL

Enrollment

464

Conditions

Prostate Cancer Ultrasound Radiomics

Interventions

Targeted biopsyDIAGNOSTIC_TEST

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

Eligibility

Sex: MALEMin age: 55 Years

Medical Language ↔ Plain English

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

Locations (1)

170th Xinsong Rd, Minhang District

Shanghai, China

Outcomes

Primary Outcomes

Positive rate of ultrasound radiomics fusion targeted biopsy

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

Positive rate of systematic biopsy

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

Positive rate of mpMRI cognitive fusion targeted biopsy

Time frame: 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.

Time frame: The 30min following the transrectal ultrasonography

Secondary Outcomes

Gleason's score of positive tissue

Gleason's score of positive tissue from targeted prostate biopsy. Prostate cancer was graded by Gleason score (GS) ranging from 6 to 10. Tumors of GS 6 (3 + 3) are considered low grade (LG), while GS ≥7 are high grade (HG).

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

PI-RADS score

Prostate Imaging Reporting and Data System (PI-RADS) score was obtained according to multiparametric magnetic resonance imaging. PI-RADS is used to standardize interpretation of prostate MRI. Each lesion is assigned a score from 1 to 5 indicating the likelihood of clinically significant cancer. PI-RADS 1: clinically significant cancer is highly unlikely to be present; PI-RADS 2: clinically significant cancer is unlikely to be present; PI-RADS 3: the presence of clinically significant cancer is equivocal; PI-RADS 4: clinically significant cancer is likely to be present; PI-RADS 5: clinically significant cancer is highly likely to be present.

Data from ClinicalTrials.gov

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