Application of Ultrasound Radiomics in Ultrasound Fusion Targeted Prostate Biopsy

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

Study Overview

• Status: Not yet recruiting
• Conditions: Prostate Cancer; Ultrasound; Radiomics

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.

• Study Type: Observational
• Enrollment (Anticipated): 300

Contacts and Locations

• Study Contact: Name: Chang He; Phone Number: 13818794604; Email: zsyhuangjq@163.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 55 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Male

• Sampling Method: Probability Sample

Study Population

Patients aged above 55 who had an indication for prostate biopsy will be screened for eligibility.

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort
Ultrasound fusion targeted biopsy; Prostate ultrasound had abnormal echo and radiomics analysis showed high scores
mpMRI cognitive fusion targeted biopsy; PI-RADS score ≥ 3

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Positive rate of ultrasound radiomics fusion targeted biopsy	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 mpMRI cognitive fusion targeted biopsy	Positive rate of mpMRI cognitive fusion targeted biopsy	Up to seventh day when the pathological results were obtained after the targeted biopsy
Ultrasound radiomics parameters	The ultrasound images are obtained by transrectal ultrasound while prostate biopsy. Then investigators use 3D-Slicer software to draw the area of interest (ROI). "Pyradiomics" library will be used to extract the radiomics features.	The 30min following the transrectal ultrasonography

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Gleason's score of positive tissue	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).	Up to seventh day when the pathological results were obtained after the targeted biopsy
PI-RADS score	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.	Within one month prior to prostate biopsy.
tPSA and fPSA	tPSA means total Prostate-Specific Antigen (PSA), and fPSA means free Prostate-Specific Antigen. If the tPSA results are in the borderline range (4 to 10), fPSA can be useful in helping distinguish between prostate cancer or benign prostatic hyperplasia (BPH).	Within one month prior to prostate biopsy.
Prostate tumor capsular invasion and positive surgical margin	The pathological specimens of the surgically resected prostate were used to determine whether there were capsular invasion or positive surgical margins. In the pathological sections, tumor cells could be identified by staining and microscopic observation at the tissue cauterization margin and capsule, and then capsular invasion or positive surgical margins could be identified.	Up to seventh day after radical prostatectomy.
Incidence of complications	Incidence of complications associated with prostate biopsy	Up to the first month after the targeted biopsy

Collaborators and Investigators

• Sponsor: Shanghai Minhang Central Hospital
• Investigators: Principal Investigator: Jiaqi Huang, Minhang hospital, Fudan University

Study record dates

Study Major Dates

• Study Start (Anticipated): March 15, 2023
• Primary Completion (Anticipated): September 30, 2023
• Study Completion (Anticipated): September 30, 2023

Study Registration Dates

• First Submitted: December 18, 2022
• First Submitted That Met QC Criteria: February 27, 2023
• First Posted (Estimate): March 9, 2023

Study Record Updates

• Last Update Posted (Estimate): March 9, 2023
• Last Update Submitted That Met QC Criteria: February 27, 2023
• Last Verified: February 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Genital Neoplasms, Male; Prostatic Diseases; Prostatic Neoplasms
• Other Study ID Numbers: Prostate Radiomics-1027

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No