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Trial Title:
Application of Ultrasound Radiomics in Ultrasound Fusion Targeted Prostate Biopsy
NCT ID:
NCT05761912
Condition:
Prostate Cancer
Ultrasound
Radiomics
Conditions: Official terms:
Prostatic Neoplasms
Study type:
Observational
Overall status:
Not yet recruiting
Study design:
Time perspective:
Prospective
Summary:
To predict prostate cancer and its prognosis by ultrasound radiomics in ultrasound fusion
prostate targeted biopsy.
Detailed description:
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.
Criteria for eligibility:
Study pop:
Patients aged above 55 who had an indication for prostate biopsy will be screened for
eligibility.
Sampling method:
Probability Sample
Criteria:
Inclusion Criteria:
1. Age ≥55 years old.
2. Patients had multiparametric magnetic resonance imaging (mpMRI) data within 3 months
before biopsy and 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
Gender:
Male
Minimum age:
55 Years
Maximum age:
N/A
Healthy volunteers:
No
Start date:
March 15, 2023
Completion date:
September 30, 2023
Lead sponsor:
Agency:
Shanghai Minhang Central Hospital
Agency class:
Other
Source:
Shanghai Minhang Central Hospital
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05761912
