Clinical trial NCT05513638: Artificial Intelligence-Based Computer-Aided Diagnosis of Prostate Cancer
Official title: Safety and Accuracy of Artificial Intelligence-aided Precision MRI Assessment for the Optimization of Prostate Biopsy in Men With Suspicion of Prostate Cancer: a Multicenter Randomized Controlled Trial.
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: the Application of Artificial Intelligence in the Diagnosis of Prostate Cancer
Keywords: artificial intelligence
prostate cancer
magnetic resonance imaging
Lead sponsor: The First Affiliated Hospital with Nanjing Medical University
Sponsor class: OTHER
Collaborators: name: The First Affiliated Hospital of Soochow University
First posted: 2022-08-24
Enrollment: 2000
Sex: MALE
Minimum age (years): 60
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients ≥ 60 years of age who are clinical suspicious of prostate cancer, presenting with an elevated prostatic specific antigen and/or abnormal digital rectal examination during the study enrollment period, will be eligible for inclusion. Patients will be excluded from screening if they are: (1) \<60 years of age; (2) a previous surgery, radiotherapy or drug therapy for prostate cancer (interventions for benign prostatic hyperplasia or bladder outflow obstruction were deemed acceptable); (3) incomplete mp-MRI examination or artifacts of the images.

Brief summary: One-fifth of all men will develop clinically significant prostate cancers (CsPC) in their lifetime. An estimated 268,490 new prostate cancer (PCa) cases and 34,500 deaths are expected in the United States during the year 2022, making PCa the second most common cause of cancer-related deaths in men. MRI with the Prostate Imaging Reporting and Data System (PI-RADS) is a current widely used communicative tool for both CsPC detection and guiding targeted prostate biopsy. The high level of expertise required for accurate interpretation and persistent inter-reader variability has limited consistency and it has hindered the widespread adoption of PI-RADS. Artificial intelligence (AI) shows a broad prospect for medical interpretation and triage in various challenging tasks , including the PCa detection and staging with MRI. While rapid technical advances are furthering the application of AI medical imaging, their implementation in clinical practice remains a major hurdle. Besides, the prospect of data-derived AI tool is to assist human experts rather than replace them, and whether AI can match or exceed the human experts is still a matter of debate. Therefore, despite strong potential, there is urgent need for research to better quantify the accuracy, generalizability and clinical applicability before the clinical use of an AI in a real-world clinical setting.


Eligibility criteria: Inclusion Criteria:

* Clinical suspicious of prostate cancer, presenting with an elevated prostatic specific antigen and/or abnormal digital rectal examination

Exclusion Criteria:

* (1) \<60 years of age; (2) a previous surgery, radiotherapy or drug therapy for prostate cancer (interventions for benign prostatic hyperplasia or bladder outflow obstruction were deemed acceptable); (3) incomplete mp-MRI examination or artifacts of the images.

Primary outcomes:
measure: biopsy or surgery confirmed newly-diagnosed prostate cancer and clinically significant prostate cancer
timeFrame: Aug,22nd,2022-Aug,22nd,2024
Secondary outcomes:
measure: surgery confirmed T and N staging of prostate cancer
timeFrame: Aug,22nd,2022-Aug,22nd,2024
measure: positive rate of prostate biopsy
timeFrame: Aug,22nd,2022-Aug,22nd,2024
measure: the total reviewing time
timeFrame: Aug,22nd,2022-Aug,22nd,2024
Other outcomes:
Locations:
city: Nanjing
country: China
facility: Yu-Dong Zhang
Study officials:
References: