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Clinical Trials in China / NCT06392737
Recruiting Not applicable

Comparison of MRI Artificial Intelligence-guided cTB Versus Routine cTB in Prostate Cancer Diagnosis

NCT06392737 · tracked via the Priya Life Science China tracker
Phase
Not applicable
Started
2024-05-01
Last updated
2025-07-02

Condition(s) studied

Prostate Cancer

Investigational drug(s) / intervention(s)

MRI-AI guided cognitive prostate targeted biopsyRoutine cognitive prostate targeted biopsy

MRI-AI guided cognitive prostate targeted biopsy: 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.

Routine cognitive prostate targeted biopsy: Before prostate biopsy, the MR images and reports were viewed by urologists preceding the biopsy. Biopsies were performed under the guidance of TRUS through the transrectal or transperineal route.

Study summary

The goal of this multicenter clinical trial is to compare the cancer detection rates of MRI artificial intelligence-guided cTB (AI-cTB) and routine cTB, and explore the added value of using AI for the guidance of cTB. The main questions it aims to answer are:

Does AI-cTB promote the accurate diagnosis and treatment of prostate cancer? What's the value of prostate MRI artificial intelligence assistant diagnosis system in developing the best scheme of prostate biopsy? What's the value of prostate MRI artificial intelligence assistant diagnosis system in predicting the pathological results of prostate targeted biopsy? What's the generalizability of the MRI artificial intelligence assistant diagnosis system?

Researchers will compare the cancer detection rates of AI-cTB and routine cTB to explore the added value of using AI for the guidance of cTB.

Participants will:

Receive AI-cTB or routine cTB.

Eligibility

Sex
MALE
Min age
45 Years
Max age
85 Years
Healthy volunteers
No
Inclusion Criteria: * The age of the patient is between 45 and 85. * Patients with complete multiparametric magnetic resonance imaging (mpMRI) data, 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 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 patients 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.

Primary outcome measure(s)

Trial sites (1)

FacilityCityRegionStatus
Peking University First Hospital Beijing Beijing Municipality Recruiting

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06392737 on ClinicalTrials.gov ↗ ← All trials in China