Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Wu Jieping Medical Foundation | OTHER |
| Shanghai Municipal Commission of Health and Family Planning | OTHER |
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Ultrasound fusion targeted biopsy | Prostate ultrasound had abnormal echo and radiomics analysis showed high scores |
| |
| Systematic biopsy | Patients meeting the indications for prostate biopsy |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Targeted biopsy | Diagnostic Test | For the high-risk targets identified by the radiomics model, perform targeted biopsy under ultrasound fusion. |
|
| 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 systematic biopsy | Positive rate of systematic 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/ITK-SNAP software to draw the area of interest (ROI). "Pyradiomics" library will be used to extract the radiomics features. | The 30min following the transrectal ultrasonography |
| 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 |
Not provided
Inclusion Criteria:
Age ≥55 years old.
Patients had tPSA/fPSA within 1 month before biopsy.
Patients had any of the following indications for prostate biopsy:
Exclusion Criteria:
Not provided
Not provided
Not provided
Patients aged above 55 who had an indication for prostate biopsy will be screened for eligibility.
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Jiaqi Huang | Minhang Hospital, Fudan University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| 170th Xinsong Rd, Minhang District | Shanghai | China |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D011471 | Prostatic Neoplasms |
| ID | Term |
|---|---|
| D005834 | Genital Neoplasms, Male |
| D014565 | Urogenital Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
Not provided
Not provided
Not provided
Not provided
Not provided
| 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. |
| Incidence of complications | Incidence of complications associated with prostate biopsy | Up to the first month after the targeted biopsy |
| D005832 |
| Genital Diseases, Male |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D011469 | Prostatic Diseases |
| D052801 | Male Urogenital Diseases |