NCT07844304Not yet recruiting
CascadeDiagnose Prostate MRI
Evaluation of the Effectiveness and Safety of CascadeDiagnose Prostate MRI: A Multi-Center Clinical Study
Source: ClinicalTrials.gov · Last updated 28 Sept 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Not yet recruiting
- Study type
- Observational
- Enrollment
- 3000 (estimated)
- First submitted
- 16 Sept 2026
- Start date
- 1 Oct 2026
- Primary completion date
- 31 Dec 2028
- Lead sponsor
- First Affiliated Hospital of Guangxi Medical University
- Diseases
- Prostate cancer
- NCT number
- NCT07844304
What you commit to
- Study type: Observational
- Planned participants: 3000
- From 1 Oct 2026 to the primary completion date, 31 Dec 2028
- 6 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Prior prostate biopsy, prostate surgery, radiotherapy, or endocrine therapy.
Other illness
- Medical history of other malignant neoplasms.
- Severe systemic diseases (e.g., heart failure, end-stage renal disease) interfering with imaging assessment or prognostic evaluation.
Other
- Substantial MRI image degradation caused by motion artifacts or metal artifacts that severely impair interpretation.
- Missing key MRI data or reference-standard materials required for primary-endpoint evaluation, precluding assessment of primary study outcomes.
Who the study is looking for
- 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.
- Patient informed consent (written informed consent required for the prospective phase).
Age in the registry: 18 years to - · Sex: Male · Does not accept healthy volunteers
Sites (6)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Guigang People's Hospital Coordinator of this site? Confirm its status | Guigang | China | Unknown status |
| Guilin People's Hospital Coordinator of this site? Confirm its status | Guilin | China | Unknown status |
| Liuzhou People's Hospital Coordinator of this site? Confirm its status | Liuzhou | China | Unknown status |
| The First Affiliated Hospital of Guangxi Medical University Coordinator of this site? Confirm its status | Nanning | China | Unknown status |
| The Second People's Hospital of Nanning Coordinator of this site? Confirm its status | Nanning | China | Unknown status |
| Wuzhou Red Cross Hospital Coordinator of this site? Confirm its status | Wuzhou | China | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.