Application of Ultrasound Radiomics in Ultrasound Fusion Targeted Prostate Biopsy

Shanghai Minhang Central Hospital

Status: Active, not recruiting

Conditions: Radiomics; Prostate Cancer; Ultrasound

Treatments: Diagnostic Test: Targeted biopsy

Study type: Observational

Funder types: Other

Identifiers

NCT05761912

Prostate Radiomics-1027

Details and patient eligibility

About

To predict prostate cancer by ultrasound radiomics in ultrasound fusion prostate targeted biopsy.

Full 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.

Enrollment: 464 estimated patients

Sex: Male

Ages: 55+ years old

Volunteers: No Healthy Volunteers

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

Trial design

464 participants in 2 patient groups

Ultrasound fusion targeted biopsy

Description:

Prostate ultrasound had abnormal echo and radiomics analysis showed high scores

Treatment:

Diagnostic Test: Targeted biopsy

Systematic biopsy

Description:

Patients meeting the indications for prostate biopsy