CascadeDiagnose Prostate MRI

NCT07844304 | Not Yet Recruiting DMC

• 1 other identifier: 2026-S061
• Study Type: observational
• Target: 3,000
• Locations: 1 country
• Sites: 6

Brief Summary

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.

Conditions

Prostate Cancer (Diagnosis)

Keywords

Prostate Cancer; MRI; Federated-learning

Outcome Measures

Primary Outcomes (2)

• Adverse Events

  All adverse events associated with system usage are documented

  up to 24 weeks

• Area under the receiver operating characteristic curve (AUC)

  overall diagnostic performance for discriminating prostate cancer from benign lesions

  up to 24 weeks

Study Arms (2)

Test group

Prostate cancer

Control group

Benign prostatic hyperplasia

Eligibility Criteria

• Age: 18 Years+
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study 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.

You may qualify if:

• 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).

You may not qualify if:

• 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.
• Severe systemic diseases (e.g., heart failure, end-stage renal disease) interfering with imaging assessment or prognostic evaluation.

Sponsors & Collaborators

• First Affiliated Hospital of Guangxi Medical University: lead

Study Sites (6)

Guigang People's Hospital

Guigang, Guangxi, 537100, China

Location

Guilin People's Hospital

Guilin, Guangxi, 541002, China

Location

Liuzhou People's Hospital

Liuzhou, Guangxi, 545006, China

Location

The First Affiliated Hospital of Guangxi Medical University

Nanning, Guangxi, 530021, China

Location

The Second People's Hospital of Nanning

Nanning, Guangxi, 530031, China

Location

Wuzhou Red Cross Hospital

Wuzhou, Guangxi, 543002, China

Location

Related Publications (3)

• Heller N, Isensee F, Maier-Hein KH, Hou X, Xie C, Li F, Nan Y, Mu G, Lin Z, Han M, Yao G, Gao Y, Zhang Y, Wang Y, Hou F, Yang J, Xiong G, Tian J, Zhong C, Ma J, Rickman J, Dean J, Stai B, Tejpaul R, Oestreich M, Blake P, Kaluzniak H, Raza S, Rosenberg J, Moore K, Walczak E, Rengel Z, Edgerton Z, Vasdev R, Peterson M, McSweeney S, Peterson S, Kalapara A, Sathianathen N, Papanikolopoulos N, Weight C. The state of the art in kidney and kidney tumor segmentation in contrast-enhanced CT imaging: Results of the KiTS19 challenge. Med Image Anal. 2021 Jan;67:101821. doi: 10.1016/j.media.2020.101821. Epub 2020 Oct 2.

  PMID: 33049579 BACKGROUND

• Sun H, Qin J, Liu Z, Jia X, Yan K, Wang L, Liu Z, Gong S. Generation driven understanding of localized 3D scenes with 3D diffusion model. Sci Rep. 2025 Apr 24;15(1):14385. doi: 10.1038/s41598-025-98705-6.

  PMID: 40274914 BACKGROUND

• Dai C, Xiong Y, Zhu P, Yao L, Lin J, Yao J, Zhang X, Huang R, Wang R, Hou J, Wang K, Shi Z, Chen F, Guo J, Zeng M, Zhou J, Wang S. Deep Learning Assessment of Small Renal Masses at Contrast-enhanced Multiphase CT. Radiology. 2024 May;311(2):e232178. doi: 10.1148/radiol.232178.

  PMID: 38742970 BACKGROUND

MeSH Terms

Conditions

Prostatic Neoplasms; Disease

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Jiwen Cheng

  First Affiliated Hospital of Guangxi Medical University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jiwen Cheng, MD.

CONTACT

0771-5358501; chengjiwen@stu.gxmu.edu.cn

Haiqi Liang, MD

CONTACT

0771-5358402; lahiki@163.com

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: OTHER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Vice President of the Hospital

Study Record Dates

• First Submitted: September 16, 2026
• First Posted: September 28, 2026
• Study Start: October 1, 2026
• Primary Completion (Estimated): December 31, 2028
• Study Completion (Estimated): December 31, 2028
• Last Updated: September 28, 2026

Record last verified: 2026-09

Data Sharing

• IPD Sharing: Will not share

Locations

CN (6)