Application of Ultrasound Radiomics in Ultrasound Fusion Targeted Prostate Biopsy

Prostate Cancer Clinical Trial

Official title:

Application of Ultrasound Radiomics in Ultrasound Fusion Targeted Prostate Biopsy

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05761912
• Other study ID #: Prostate Radiomics-1027
• Status: Not yet recruiting
• Start date: March 15, 2023
• Est. completion date: September 30, 2023

Study information

• Verified date: February 2023
• Source: Shanghai Minhang Central Hospital
• Contact: Chang He
• Phone: 13818794604
• Email: zsyhuangjq[@]163.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 300
• Est. completion date: September 30, 2023
• Est. primary completion date: September 30, 2023
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 55 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Prostate Cancer
• Prostatic Neoplasms
• Radiomics
• Ultrasound

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Shanghai Minhang Central Hospital

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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	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
Secondary	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.
Secondary	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.
Secondary	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.
Secondary	Incidence of complications	Incidence of complications associated with prostate biopsy	Up to the first month after the targeted biopsy