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NCT Number: NCT06842264

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

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.

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Key information

Sex eligibility

Male

Study type

Observational

Primary location

Peking University First Hospital

Beijing, 100034, China

Location status: Recruiting

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. Biopsy pathology results

    Time frame: 1week after biopsy

    The 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Yi LIU

CONTACT

[email protected]

+8613611035261

Yi LIU

CONTACT

[email protected]

Sponsors and collaborators

Lead sponsor

Peking University First Hospital

Other

Registry information

Important dates

Study start
2024
Primary completion
2029
Study completion
2029
First posted
Feb 24, 2025
Registry last updated
Jan 29, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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