This clinical trial studies whether artificial intelligence (AI) software can help radiologists interpret prostate magnetic resonance imaging (MRI) results and detect prostate cancer. AI is the branch of computer science that deals with writing computer programs that can solve problems creatively. The AI software being used in this study is called AI-Rad Companion (AIRC). The AIRC software measures the volume of different organs, and uses the measurements to detect potential lesions, or areas of damaged tissue, in the organ. The software also gives a score to each lesion, which tells the radiologist how likely a lesion may be a cancer. Using AI software may be a more effective way to help radiologists interpret prostate MRI results and detect prostate cancer.
Study sponsor and potential other locations can be found on ClinicalTrials.gov for NCT07084779.
Locations matching your search criteria
United States
Ohio
Cleveland
Case Comprehensive Cancer CenterStatus: Active
Contact: Andrei Purysko
Phone: 216-445-9005
PRIMARY OBJECTIVE:
I. To investigate the impact of AI software to improve further the standard of care in prostate cancer detection and treatment.
SECONDARY OBJECTIVES:
I. Compare the inter-reader agreement on the presence/absence of clinically significant prostate cancer (csPCa) at the patient-level for the unaided versus (vs) aided read.
II. Compare the inter-reader agreement on the presence/absence of csPCa at the quadrant-level during the unaided vs aided read.
III. Compare the patient-level sensitivity and specificity of the unaided vs aided read.
IV. Compare the quadrant-level sensitivity and specificity of the unaided vs aided read.
V. Construct a free-response receiver operator characteristics (ROC) curve for the aided and unaided reads.
VI. Compare the quadrant-level area under the receiver operating characteristic curve (AUC) of the unaided vs AI read.
OUTLINE:
Patients undergo standard of care (SOC) MRI and the images undergo interpretation by a radiologist alone and aided by AI prior to scheduled prostate biopsy. Patients also undergo prostate biopsy on study.
Trial PhaseNo phase specified
Trial Typediagnostic
Lead OrganizationCase Comprehensive Cancer Center
Principal InvestigatorAndrei Purysko
