Comprehensive Evaluation of MRI-AI in Prostate Cancer Diagnosis

NCT06575361 | Completed

• 1 other identifier: AITB-003
• Study Type: interventional
• Target: 365
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Prostate Cancer

Keywords

Prostate cancer; Artificial intelligence; Targeted biopsy; Diagnosis; Diagnostic study

Outcome Measures

Primary Outcomes (2)

• The clinically significant prostate cancer (csPCa) detection rate for suspicious lesions found by MRI-AI and urogenital radiologists

  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.

  One month after the biopsy procedure.

• High-grade PCa detection rate

  High-grade PCa was defined as PCa with a grade group ≥3 or GS ≥ 4+3. The reference standard was the pathological results of targeted biopsies for the suspicious lesions.

  One month after the biopsy procedure.

Secondary Outcomes (3)

• The PCa detection rate

  One month after the biopsy procedure.

• clinically insignificant PCa (ciPCa) detection rate

  One month after the biopsy procedure.

• Diagnostic performance

  One month after the biopsy procedure

Study Arms (1)

Patients with the indication of prostate biopsy

EXPERIMENTAL

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).

Diagnostic Test: Combination of targeted biopsy and systematic biopsy

Interventions

Combination of targeted biopsy and systematic biopsy DIAGNOSTIC_TEST

Before prostate biopsy, the MR images of patients were independently reviewed by MRI-AI and urogenital radiologists. Then the images with suspicious lesions highlighted by MRI-AI and urogenital radiologists. Urologists conducted targeted biopsies for all suspicious lesions and systematic biopsies. Biopsies were performed under the guidance of transrectal ultrasound (TRUS) through the transrectal or transperineal route.

Patients with the indication of prostate biopsy

Eligibility Criteria

• Age: 45 Years - 85 Years
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Peking University First Hospital: lead

Study Sites (1)

Peking University First Hospital

Beijing, Beijing Municipality, 100034, China

Location

MeSH Terms

Conditions

Prostatic Neoplasms; Disease

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Yi LIU

  Peking University First Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate chief physician

Study Record Dates

• First Submitted: August 26, 2024
• First Posted: August 28, 2024
• Study Start: January 1, 2024
• Primary Completion: June 30, 2025
• Study Completion: August 31, 2025
• Last Updated: May 6, 2026

Record last verified: 2026-05

Locations

CN (1)