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The Development and Validation of MRI-AI-based Predictive Models for csPCa

The Development and Validation of MRI-AI-based Predictive Models for csPCa

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT06842264
Enrollment
3000
Registered
2025-02-24
Start date
2024-01-01
Completion date
2029-12-31
Last updated
2026-01-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Prostate Cancer

Keywords

clinically-significant prostate cancer, artificial intelligence, magnetic resonance imaging, predictive model

Brief summary

This study retrospectively included patients who underwent prostate magnetic resonance imaging (MRI) and subsequent ultrasound-guided prostate biopsy at Peking University First Hospital from January 2019 to December 2023, and prospectively enrolls patients from January 2024 to December 2029. Clinical information such as age, PSA levels, PI-RADS scores, and digital rectal examination findings are collected. A well-performing artificial intelligence model is employed to measure prostate volume, transitional zone volume, and lesion volume using MRI images. Furthermore, prostate-specific antigen density (PSAD), transitional zone-based prostate-specific antigen density (TZ-PSAD) and lesion-based prostate-specific antigen density (lesion-PSAD) are calculated using prostate volume, transitional zone volume and lesion volume. Utilizing the aforementioned data, machine learning predictive models for clinically-significant prostate cancer (csPCa) are developed and validated.

Detailed description

This study retrospectively included patients who underwent prostate magnetic resonance imaging (MRI) and subsequent ultrasound-guided prostate biopsy at Peking University First Hospital from January 2019 to December 2023, and prospectively enrolls patients from January 2024 to December 2029. Clinical information such as age, PSA levels, PI-RADS scores, and digital rectal examination findings are collected. A well-performing artificial intelligence model is employed to measure prostate volume, transitional zone volume, and lesion volume using MRI images. Furthermore, prostate-specific antigen density (PSAD), transitional zone-based prostate-specific antigen density (TZ-PSAD) and lesion-based prostate-specific antigen density (lesion-PSAD) are calculated using prostate volume, transitional zone volume and lesion volume. Utilizing the aforementioned data, machine learning predictive models for clinically-significant prostate cancer (csPCa) are developed and validated

Interventions

None listed

Sponsors

Peking University First Hospital
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
MALE
Healthy volunteers
No

Inclusion criteria

* The interval between prostate MRI and biopsy within 3 months * Integrity of related data

Exclusion criteria

* PSA less than 50ng/ml * Any treatment for PCa prior to either MRI or biopsy, including radical prostatectomy, radiotherapy, chemotherapy, and endocrine therapy * Previous history of surgical treatment or 5α-reductase inhibitor therapy for benign prostatic hyperplasia * Subjects undergoing MRI with an indwelling urinary catheter or suprapubic catheter * Inadequate quality of MRI images

Design outcomes

Primary

MeasureTime frameDescription
Biopsy pathology results1week after biopsyThe pathology report will include the ISUP grade; if it is greater than or equal to 2, it is considered csPCa (clinically significant prostate cancer), otherwise, it is classified as non-csPCa.

Countries

China

Contacts

CONTACTYi LIU
liuyipkuhsc@163.com+8613611035261
PRINCIPAL_INVESTIGATORYi LIU

Dept. of Urology, Peking University First Hospital

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026