AI Multimodal Model for Predicting CRPC Progression Risk

NCT07658573 | Active Not Recruiting

• 1 other identifier: KY20250243
• Study Type: observational
• Target: 500
• Locations: 1 country
• Sites: 1

Brief Summary

This study aims to develop an artificial intelligence model to predict which patients with advanced prostate cancer are at higher risk of developing castration-resistant prostate cancer (CRPC), a more severe form of the disease. The study will use pre-treatment MRI images, biopsy pathology slides, and clinical data collected from patients who received either hormone therapy (ADT) or radical prostatectomy surgery. By integrating these different types of data, the AI model is designed to help doctors identify high-risk patients earlier, personalize treatment plans, and ultimately improve patient outcomes. This is a multicenter, retrospective study that will analyze data from over 500 patients with at least 24 months of follow-up. The performance of the model will be evaluated using standard accuracy metrics.

Conditions

Prostate Cancer; Castration-Resistant Prostate Cancer

Outcome Measures

Primary Outcomes (2)

• Prediction of CRPC Progression Risk in the ADT Treatment Group

  Performance of the multimodal AI model in predicting progression to castration-resistant prostate cancer in patients with newly diagnosed advanced prostate cancer who received at least 6 months of androgen deprivation therapy. Metrics include AUC, accuracy, sensitivity, and specificity.

  Minimum 24 months of follow-up

• Prediction of CRPC Progression Risk in the Radical Prostatectomy Group

  Performance of the multimodal AI model in predicting progression to castration-resistant prostate cancer in patients with newly diagnosed advanced prostate cancer who underwent radical prostatectomy. Metrics include AUC, accuracy, sensitivity, and specificity.

  Minimum 24 months of follow-up

Study Arms (2)

ADT Treatment Group

Patients with newly diagnosed advanced prostate cancer who received at least 6 months of androgen deprivation therapy.

Radical Prostatectomy Group

Patients with localized or locally advanced prostate cancer who underwent radical prostatectomy.

Eligibility Criteria

• Age: 18 Years - 80 Years
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Male patients with newly diagnosed advanced prostate cancer

You may qualify if:

• (1) Male, age ≥18 years; (2) Pathologically confirmed newly diagnosed advanced prostate cancer; (3) Received at least 6 months of androgen deprivation therapy OR underwent radical prostatectomy; (4) Have complete baseline MRI (T2WI, DWI, ADC) and biopsy pathology data; (5) Have complete follow-up records (at least 24 months).

You may not qualify if:

• (1) Missing clinical information; (2) MRI images of poor quality or missing key sequences; (3) Poor quality pathological specimens; (4) Lost to follow-up or incomplete data during follow-up; (5) Concurrent other malignant tumors; (6) Prior anti-tumor therapy.

Sponsors & Collaborators

• Guangxi Medical University: lead

Study Sites (1)

Guangxi Medical University First Affiliated Hospital

Nan'ning, China

Location

Biospecimen

Retention: SAMPLES WITH DNA

Tumor tissue or pathological slides

MeSH Terms

Conditions

Prostatic Neoplasms

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Doctor of Medicine

Study Record Dates

• First Submitted: June 14, 2026
• First Posted: June 22, 2026
• Study Start: June 1, 2025
• Primary Completion (Estimated): June 1, 2028
• Study Completion (Estimated): June 1, 2028
• Last Updated: June 22, 2026

Record last verified: 2026-06

Locations

CN (1)