Clinical trial NCT05761912: Application of Ultrasound Radiomics in Ultrasound Fusion Targeted Prostate Biopsy
Official title: Application of Ultrasound Radiomics in Ultrasound Fusion Targeted Prostate Biopsy
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Prostate Cancer
Ultrasound
Radiomics
Lead sponsor: Shanghai Minhang Central Hospital
Sponsor class: OTHER
First posted: 2023-03-09
Enrollment: 300
Sex: MALE
Minimum age (years): 55
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients aged above 55 who had an indication for prostate biopsy will be screened for eligibility.

Brief 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.

Eligibility 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

Primary outcomes:
measure: Positive rate of ultrasound radiomics fusion targeted biopsy
timeFrame: Up to seventh day when the pathological results were obtained after the targeted biopsy
measure: Positive rate of mpMRI cognitive fusion targeted biopsy
timeFrame: Up to seventh day when the pathological results were obtained after the targeted biopsy
measure: Ultrasound radiomics parameters
timeFrame: The 30min following the transrectal ultrasonography
Secondary outcomes:
measure: Gleason's score of positive tissue
timeFrame: Up to seventh day when the pathological results were obtained after the targeted biopsy
measure: PI-RADS score
timeFrame: Within one month prior to prostate biopsy.
measure: tPSA and fPSA
timeFrame: Within one month prior to prostate biopsy.
measure: Prostate tumor capsular invasion and positive surgical margin
timeFrame: Up to seventh day after radical prostatectomy.
measure: Incidence of complications
timeFrame: Up to the first month after the targeted biopsy
Other outcomes:
Locations:
Study officials:
affiliation: Minhang Hospital, Fudan University
name: Jiaqi Huang
role: PRINCIPAL_INVESTIGATOR
References: