Clinical trial NCT06575361: Comprehensive Evaluation of MRI-AI in Prostate Cancer Diagnosis
Official title: Comprehensive Evaluation of MRI-AI in Prostate Cancer Diagnosis: a Real-World Prospective Diagnostic Study
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Prostate Cancer
Keywords: Prostate cancer
Artificial intelligence
Targeted biopsy
Diagnosis
Diagnostic study
Lead sponsor: Peking University First Hospital
Sponsor class: OTHER
First posted: 2024-08-28
Enrollment: 1000
Sex: MALE
Minimum age (years): 45
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

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.

Detailed description: In recent years, there have been remarkable advancements in the field of artificial intelligence (AI) techniques, particularly in the medical domain. These AI techniques have demonstrated the ability to significantly enhance various medical tasks, such as tumor detection, classification, and prognosis prediction. Increasing evidence supports the ability of AI to facilitate precise diagnosis of PCa and assist in therapeutic decisions. Compared with doctors, AI has the potential to identify not only holistic tumor morphology but also task-specific and granular radiological patterns that cannot be detected by the naked eye. Therefore, AI has great potential to reduce inconsistencies between observers and improve diagnostic accuracy. Previous AI studies at our institution have developed deep learning-based AI models trained on MR images that achieve good performance in the detection and localization of clinically significant prostate cancer (csPCa). Furthermore, the trained AI algorithms were embedded into proprietary structured reporting software, and radiologists simulated their real-life work scenarios to interpret and report the PI-RADS category of each patient using this AI-based software. However, the data is mostly retrospective. The capability of detecting the suspicious lesions on MRI, guiding the prostate targeted biopsy, and optimizing the biopsy scheme warrants further investigation.

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.

Eligibility criteria: Inclusion Criteria:

* The age of the patient is between 45 and 85.
* 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.
* 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 of Peking University First Hospital 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.

Primary outcomes:
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.
Secondary outcomes:
measure: The PCa detection rate
timeFrame: One month after the biopsy procedure.
measure: The Gleason score (GS) of the biopsy sample
timeFrame: One month after the biopsy procedure.
measure: The GS of radical prostatectomy (RP) specimens
timeFrame: One month after the biopsy procedure.
Other outcomes:
Locations:
city: Beijing
country: China
facility: Peking University First Hospital
state: Beijing
Study officials:
affiliation: Peking University First Hospital
name: Yi LIU
role: PRINCIPAL_INVESTIGATOR
References: