Prostate Cancer, Radiomics, Ultrasound
Conditions
Brief summary
To predict prostate cancer by ultrasound radiomics in ultrasound fusion prostate targeted biopsy.
Detailed description
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.
Interventions
DIAGNOSTIC_TESTTargeted biopsy
For the high-risk targets identified by the radiomics model, perform targeted biopsy under ultrasound fusion.
Sponsors
Shanghai Minhang Central Hospital
Wu Jieping Medical Foundation
Shanghai Municipal Commission of Health and Family Planning
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
MALE
Age
55 Years to No maximum
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Gleason's score of positive tissue | Up to seventh day when the pathological results were obtained after the targeted biopsy | 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). |
| PI-RADS score | Within one month prior to prostate biopsy. | 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. |
| Incidence of complications | Up to the first month after the targeted biopsy | Incidence of complications associated with prostate biopsy |
Countries
China
Contacts
PRINCIPAL_INVESTIGATORJiaqi Huang
Minhang Hospital, Fudan University
Outcome results
None listed