CascadeDiagnose Prostate MRI
ConditionProstate Cancer (Diagnosis)
Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexMale
Age18+
SponsorFirst Affiliated Hospital of Guangxi Medical University
About this trial
This multicenter clinical study is evaluating CascadeDiagnose Prostate MRI, an artificial-intelligence software tool that analyzes standard prostate MRI scans-T2-weighted, diffusion-weighted, and ADC images-to help radiologists detect suspicious prostate lesions, estimate cancer risk, and distinguish prostate cancer from benign conditions. The study will take place at six hospitals in Guangxi and plans to enroll at least 2,000 eligible men aged 18 or older who have had prostate MRI and have confirmed pathology results. It includes a retrospective phase using existing records and a prospective phase in which participants provide written informed consent. The main goals are to measure the system's diagnostic accuracy (AUC, sensitivity, and specificity), compare it with readings by radiologists, assess safety and rates of rejected or indeterminate results, and see whether it improves reading efficiency or helps reduce unnecessary biopsies. To protect patient privacy, raw MRI, medical-record, and pathology data remain inside each hospital; only de-identified, encrypted intermediate results are shared through a secure distributed network. The study requires ethics approval and trial registration before enrollment, and its results may help determine whether this AI tool is safe and effective for clinical use.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Male patients aged ≥ 18 years undergoing prostate MRI examination.
Complete MRI sequences including at minimum T2WI, DWI, and ADC sequences.
Definitive pathological diagnosis (prostate biopsy or post-surgical pathology) with complete Gleason-score information.
Complete clinical data including serum PSA level, age, and prior medical history.
Disqualifiers
Substantial MRI image degradation caused by motion artifacts or metal artifacts that severely impair interpretation.
Prior prostate biopsy, prostate surgery, radiotherapy, or endocrine therapy.
Medical history of other malignant neoplasms.
Missing key MRI data or reference-standard materials required for primary-endpoint evaluation, precluding assessment of primary study outcomes.
Trial population
The study will enroll at least 2,000 eligible men aged 18 years or older with complete prostate MRI (T2WI, DWI, ADC), definitive pathology with Gleason score, and full clinical data including PSA, age, and medical history-approximately 1,500 retrospectively and 500 prospectively. Key exclusions are severe image artifacts, prior prostate biopsy, surgery, radiotherapy or endocrine therapy, other malignancies, missing key MRI or reference-standard data, and severe systemic disease interfering with assessment. Written informed consent is required prospectively, with a possible waiver for retrospective data per local ethics committee.
Trial design
Design model
Case-control
Time perspective
Other
Treatments tested in this trial
Not listed
Trial groups
3,000 Participants
are grouped into 2 trial groupsGroup A: Test group
Group B: Control group
Trial outcomes
Primary outcomes
1
Adverse Events
All adverse events associated with system usage are documented
Time frame
up to 24 weeks2
Area under the receiver operating characteristic curve (AUC)
overall diagnostic performance for discriminating prostate cancer from benign lesions
Time frame
up to 24 weeksSponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov
This trial is not recruiting at the moment. You can still explore other options: