Application of Ultrasound Radiomics in Ultrasound Fusion Targeted Prostate Biopsy

Shanghai Minhang Central Hospital

Status: Not yet enrolling

Conditions: Radiomics; Prostate Cancer; Ultrasound

Study type: Observational

Funder types: Other

Identifiers

NCT05761912

Prostate Radiomics-1027

Details and patient eligibility

About

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

Full 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.

Enrollment: 300 estimated patients

Sex: Male

Ages: 55+ years old

Volunteers: No Healthy Volunteers

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

Trial design

300 participants in 2 patient groups

Ultrasound fusion targeted biopsy

Description:

Prostate ultrasound had abnormal echo and radiomics analysis showed high scores

mpMRI cognitive fusion targeted biopsy

Description:

PI-RADS score ≥ 3