Comparison of MRI AI-cTB Versus Routine cTB in Prostate C... | NCT06362291

Status Module

Description Module

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
MRI-AI-guided cTB (AI-cTB) group	Experimental	The trained AI algorithms were embedded into proprietary structured reporting software. Before prostate biopsy, the MR images of patients in the AI-cTB group were uploaded to the AI software. The prostate gland and suspicious lesions were annotated and highlighted by AI software. The urologists who were blinded to the picture archiving and communication system (PACS) and MRI reports read the AI findings at their discretion and then conducted 3-5 core TB at each suspicious lesion, followed by 12 core SB. If there was no suspicious lesion detected by the AI, only SB would be performed.	Procedure: MRI-AI guided cognitive prostate targeted biopsy
Routine cTB group	Experimental	For patients in the cTB group, the MR images and reports were viewed by urologists preceding the biopsy. Then 3-5 core cTB were performed, followed by 12 core SB. In patients with negative MRI findings, only SB was performed. When urologists performed biopsies, ultrasound technicians and radiologists were present to provide necessary assistance.	Procedure: Routine cognitive prostate targeted biopsy

Interventions

Name	Type	Description	Arm Group Labels	Other Names
MRI-AI guided cognitive prostate targeted biopsy	Procedure	Before prostate biopsy, the MR images of patients in the AI-cTB group were uploaded to the AI software. Then the images with suspicious lesions highlighted by AI software were viewed by urologists. Biopsies were performed under the guidance of TRUS through the transrectal or transperineal route.

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
The clinically significant prostate cancer (csPCa) detection rate for targeted biopsy (TB) and TB combined with systematic biopsy (SB)	csPCa was defined as PCa with a grade group > 2 or GS ≥ 7. The reference standard was the pathological results of the combination of TB (AI-cTB or cTB) and SB.	One month after the biopsy procedure.

Secondary Outcomes

Measure	Description	Time Frame
The PCa detection rate	The PCa detection rate for targeted biopsy (TB) and TB combined with systematic biopsy (SB)	One month after the biopsy procedure.
The Gleason score (GS) of the biopsy sample

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

The age of the patient is between 45 and 85.
Patients with complete multiparametric magnetic resonance imaging (mpMRI) data of Peking University First Hospital, qualified image quality control, suspicious lesions, and Prostate Imaging Reporting and Data System version 2.1 (PI-RADS V2.1) of ≥ 3.
Patients were in accordance with the indication of prostate biopsy, including patients with suspicious prostate nodes found by digital rectal examination (DRE), the suspicious lesions found by transrectal ultrasound (TRUS) or MRI, total prostate-specific antigen (tPSA) >10ng/mL, tPSA 4-10ng/mL with free-to-total PSA ratio (f/tPSA) <0.16 or PSA density (PSAD) >0.15.
Patients were in accordance with the indication of repeated prostate biopsy (patients with atypical acinar hyperplasia or high-grade intraepithelial neoplasia, especially when the pathological results of multi-needle puncture were as above; re-examination of PSA > 10 ng/ml; re-examination of PSA 4~10ng/ml, abnormal f/tPSA, abnormal PSAD, abnormal DRE, or imaging abnormalities; for patients with the results of re-examination of PSA 4~10ng/ml and with close follow-up, PSA for 2 consecutive years > 10ng/ml or PSA volume > 0.75/ml/ years). The time interval between the two prostate biopsies should be longer than three months.
The targeted prostate biopsy pathological results of above lesions were complete. The time interval between targeted prostate biopsy and prostate mpMRI examination should not exceed one month.
Patients with complete clinical information.

Exclusion Criteria:

The mpMRI data was unqualified or incomplete.
Patients had received radiotherapy, chemotherapy, androgen deprivation therapy, or surgery treatment before prostate mpMRI examination or prostate biopsy.
The mpMRI of Peking University First Hospital did not find suspicious prostate lesions.
Patients were not in accordance with the indication of prostate biopsy or were not received systematic biopsy combined with targeted biopsy.
The patient could not cooperate to complete the systematic biopsy combined with targeted biopsy. The patients or their family members refused to participate in this study.
Patients with incomplete clinical information.

Name	Affiliation	Role
Yi LIU	Peking University First Hospital	Principal Investigator

Facility	Status	City	State	ZIP	Country	Contacts
Peking University First Hospital		Beijing	Beijing Municipality	100034	China

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
39533250	Derived	Deng R, Liu Y, Wang K, Ruan M, Li D, Wu J, Qiu J, Wu P, Tian P, Yu C, Shang J, Zhao Z, Zhou J, Cai L, Wang X, Gong K. Comparison of MRI artificial intelligence-guided cognitive fusion-targeted biopsy versus routine cognitive fusion-targeted prostate biopsy in prostate cancer diagnosis: a randomized controlled trial. BMC Med. 2024 Nov 13;22(1):530. doi: 10.1186/s12916-024-03742-z.

ID	Term
D011471	Prostatic Neoplasms
D004194	Disease

ID	Term
D005834	Genital Neoplasms, Male
D014565	Urogenital Neoplasms
D009371	Neoplasms by Site
D009369	Neoplasms
D005832	Genital Diseases, Male
D000091662	Genital Diseases
D000091642	Urogenital Diseases
D011469	Prostatic Diseases
D052801	Male Urogenital Diseases
D010335	Pathologic Processes
D013568	Pathological Conditions, Signs and Symptoms