NCT06392737 Comparison of MRI Artificial Intelligence-guided cTB Versus Routine cTB in Prostate Cancer Diagnosis
| NCT ID | NCT06392737 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Peking University First Hospital |
| Condition | Prostate Cancer |
| Study Type | INTERVENTIONAL |
| Enrollment | 360 participants |
| Start Date | 2024-05-01 |
| Primary Completion | 2026-03-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 360 participants in total. It began in 2024-05-01 with a primary completion date of 2026-03-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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 Criteria
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.
Contact & Investigator
Yi LIU
PRINCIPAL INVESTIGATOR
Peking University First Hospital
Frequently Asked Questions
Who can join the NCT06392737 clinical trial?
This trial is open to male participants only, aged 45 Years or older, up to 85 Years, studying Prostate Cancer. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06392737 currently recruiting?
Yes, NCT06392737 is actively recruiting participants. Contact the research team at liuyipkuhsc@163.com for enrollment information.
Where is the NCT06392737 trial being conducted?
This trial is being conducted at Beijing, China.
Who is sponsoring the NCT06392737 clinical trial?
NCT06392737 is sponsored by Peking University First Hospital. The principal investigator is Yi LIU at Peking University First Hospital. The trial plans to enroll 360 participants.
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