CompletedNot Applicable

Comprehensive Evaluation of MRI-AI in Prostate Cancer Diagnosis

China365 participantsStarted 2024-01-01

Plain-language summary

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.

Who can participate

Age range45 Years – 85 Years

SexMALE

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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.

What they're measuring

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.

High-grade PCa detection rate

Timeframe: One month after the biopsy procedure.

Trial details

NCT IDNCT06575361

SponsorPeking University First Hospital

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2025-06-30