Clinical trial · Interventional
Comparison of MRI AI-cTB Versus Routine cTB in Prostate Cancer Diagnosis: a Prospective Randomized Controlled Trial
Comparison of MRI Artificial Intelligence-guided Cognitive Fusion-targeted Biopsy Versus Routine Cognitive Fusion-targeted Prostate Biopsy in Prostate Cancer Diagnosis: a Prospective Randomized Controlled Trial
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
The goal of this 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? 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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Prostate Cancer | Malignant Prostate Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| MRI-AI guided cognitive prostate targeted biopsy | Procedure | — | UNRESOLVED |
| Routine cognitive prostate targeted biopsy | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- MRI-AI-guided cTB (AI-cTB) group
- description
- 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.
- interventionNames
- Procedure: MRI-AI guided cognitive prostate targeted biopsy
- type
- EXPERIMENTAL
- label
- Routine cTB group
- description
- 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.
- interventionNames
Eligibility
Eligibility (as posted)
- Sex
- Male
- Minimum age
- 45 Years
- Maximum age
- 85 Years
Show eligibility criteria text
Inclusion Criteria: 1. The age of the patient is between 45 and 85. 2. 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. 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. 4. 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. 5. 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. 6. Patients with complete clinical information. Exclusion Criteria: 1. The mpMRI data was unqualified or incomplete. 2. Patients had received radiotherapy, chemotherapy, androgen deprivation therapy, or surgery treatment before prostate mpMRI examination or prostate biopsy. 3. The mpMRI of Peking University First Hospital did not find suspicious prostate lesions. 4. Patients were not in accordance with the indication of prostate biopsy or were not received systematic biopsy combined with targeted biopsy. 5. 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. 6. Patients with incomplete clinical information.
References
Publications (1)
- DERIVEDDeng 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. PMID 39533250