Application of Ultrasound Radiomics in Ultrasound Fusion Targeted Prostate Biopsy

Study Overview
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Brief Summary
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To predict prostate cancer and its prognosis by ultrasound radiomics in ultrasound fusion prostate targeted biopsy.

Detailed Description
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Investigators plan to develop a diagnostic and prognostic evaluation model for prostate cancer according to analyze the abnormal echo of prostate ultrasound images by radiomics. The model was used to perform ultrasound radiomics fusion prostate biopsy, and the accuracy was compared with that of MRI cognitive fusion biopsy.

Official Title
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Application of Ultrasound Radiomics in Ultrasound Fusion Targeted Prostate Biopsy

Conditions
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Prostate Cancer, Ultrasound, Radiomics

Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age ≥55 years old. Patients had multiparametric magnetic resonance imaging (mpMRI) data within 3 months before biopsy and tPSA/fPSA within 1 month before biopsy. 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: malignant tumors other than prostate adenocarcinoma indicated by pathology. 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. Other conditions that would preclude needle biopsy: cachexia, decompensation of organ function, hemorrhagic diseases, local infection, etc

Ages Eligible for Study
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Minimum Age: 55 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Ultrasound fusion targeted biopsy<br>Prostate ultrasound had abnormal echo and radiomics analysis showed high scores | |
| mpMRI cognitive fusion targeted biopsy<br>PI-RADS score ≥ 3 | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Positive rate of ultrasound radiomics fusion targeted biopsy | 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 mpMRI cognitive fusion targeted biopsy | Positive rate of mpMRI cognitive fusion targeted biopsy | 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 software to draw the area of interest (ROI). Pyradiomics library will be used to extract the radiomics features. | The 30min following the transrectal ultrasonography | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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). | 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. | Within one month prior to prostate biopsy. | 
| tPSA and fPSA | tPSA means total Prostate-Specific Antigen (PSA), and fPSA means free Prostate-Specific Antigen. If the tPSA results are in the borderline range (4 to 10), fPSA can be useful in helping distinguish between prostate cancer or benign prostatic hyperplasia (BPH). | Within one month prior to prostate biopsy. | 
| Prostate tumor capsular invasion and positive surgical margin | The pathological specimens of the surgically resected prostate were used to determine whether there were capsular invasion or positive surgical margins. In the pathological sections, tumor cells could be identified by staining and microscopic observation at the tissue cauterization margin and capsule, and then capsular invasion or positive surgical margins could be identified. | Up to seventh day after radical prostatectomy. | 
| Incidence of complications | Incidence of complications associated with prostate biopsy | Up to the first month after the targeted biopsy |