Clinical trial · Interventional
Comprehensive Evaluation of MRI-AI in Prostate Cancer Diagnosis
Comprehensive Evaluation of MRI-AI in Prostate Cancer Diagnosis: a Real-World Prospective Diagnostic Study
- 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 real-world prospective diagnostic study is to comprehensively evaluate the value of MRI artificial intelligence (MRI-AI) in assisting the diagnosis of prostate cancer (PCa). The main questions it aims to answer are: Does MRI-AI promote the accurate diagnosis and treatment of prostate cancer? What's the capability of prostate MRI-AI in calculating the prostate volumn? What's the value of prostate MRI-AI assistant diagnosis system in detecting the suspicious lesions on MRI and guiding prostate targeted biopsy? What's the value of prostate MRI-AI assistant diagnosis system in predicting the pathological results of prostate targeted biopsy? Researchers will compare the cancer detection rates of suspicious lesions detected by MRI-AI and senior radiologists. Participants will: Receive combination of systematic biopsy and targeted biopsy.
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 (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Combination of targeted biopsy and systematic biopsy | Diagnostic Test | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Patients with the indication of prostate biopsy
- description
- The trained AI algorithms were embedded into proprietary structured reporting software. Before prostate biopsy, the MR images of patients were uploaded to the AI software. The prostate gland and suspicious lesions were annotated and highlighted by AI software. Urogenital radiologists who were blinded to MRI-AI reports independently reviewed the MR images, annotated the suspicious lesions. Then the urologists read both the MRI-AI reports and urogenital radiologist's reports, and conducted 3-5 core targeted biopsy (TB) at each suspicious lesion found by MRI-AI and urogenital radiologists, followed by 12 core systematic biopsy (SB).
- interventionNames
- Diagnostic Test: Combination of targeted biopsy and systematic biopsy
Primary outcomes (2)
- measure
- The clinically significant prostate cancer (csPCa) detection rate for suspicious lesions found by MRI-AI and urogenital radiologists
- timeFrame
- One month after the biopsy procedure.
- description
- csPCa was defined as PCa with a grade group ≥ 2 or GS ≥ 3+4. The reference standard was the pathological results of targeted biopsies for the suspicious lesions.
Eligibility
Eligibility (as posted)
- Sex
- Male
- Minimum age
- 45 Years
- Maximum age
- 85 Years
Show eligibility criteria text
Inclusion Criteria: * The age of the patient is between 45 and 85. * Patients with complete magnetic resonance imaging (MRI) data, qualified image quality control. * 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 had no history of prior prostate surgery or biopsy. * The PSA of patients should be ≤20 ng/mL. * The prostate biopsy pathological results of above lesions were complete. The time interval between targeted prostate biopsy and prostate MRI examination should not exceed one month. * Patients with complete clinical information. Exclusion Criteria: * The clinicopathological information and MRI data was unqualified or incomplete. * Patients had received radiotherapy, chemotherapy, androgen deprivation therapy, or surgery treatment before prostate MRI examination or prostate biopsy. * Patients received prior prostate biopsy. * Patients had contraindications to MRI or prostate biopsy. * Patients were not in accordance with the indication of prostate biopsy.
References
Publications (0)
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