Development and Prospective Validation of a Pathology-Based Artificial Intelligence Model for Predicting the Time to Castration Resistance of Prostate Cancer

Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexMale
Age18+
SponsorSun Yat-Sen Memorial Hospital of Sun Yat-Sen University

About this trial

The goal of this predictive test is to prospectively test the performance of pre-developed artificial intelligence (AI) predictive model for predicting the time to castration resistance of prostate cancer. Investigators had developed this AI model based on deep learning algorithms in preliminary research, and it performed well in retrospective tests.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Patients are diagnosed with intermediate- to high-risk prostate cancer; undergo prostate biopsy

Patients only received endocrine therapy for prostate cancer;

Patients with complete clinical and pathological information.

Patients agree to participate in this diagnostic test.

Disqualifiers

Patients with other tumors and undergo systemic therapy .

The patient refused to participate in this diagnostic test.

Trial population

Patients with prostate cancer, undergo prostate biopsy between Jan, 2026 and Dec 2026 in Sun Yat-sen Memorial Hospital of Sun Yat-sen University are planned to be enrolled in this prospective predictive test. Histopathological slides of biopsy tissues of enrolled patients will be collected and digitised as whole-slide images (WSIs) for prospective validation of the AI model.

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

  • Artificial intelligence (AI)-based predictive model (developed)

    Other intervention

    Collect pathological slides of prostate biopsy of the enrolled patients. Digitise these slides into whole-slide images (WSIs). Analyze the WSIs using the AI model to generate predictive results (within 12 months, between 12 to 24months or over 24 months). No intervention to patients would be performed in this predictive test study.

Treatment groups

150 Participants
are divided into 1 treatment group
Group A: Patients undergo prostate biopsy1 intervention

Trial outcomes

Primary outcomes

1

C-index (Concordance Index)

The proportion of all patient pairs in which the predicted outcome order matches the actual outcome order. It estimates the probability that the predicted results are consistent with the observed outcomes.

Time frame
For each enrolled patient, the predictive results of AI model will be obtained in not long after prostate biopsy, and the C-index of the AI model will be evaluated through study completion, an average of 3 year.

Secondary outcomes

1

sensitivity

The output of the predictive model is divided into a binary variable using a 12-month threshold: TTCR \<12 months is considered a positive outcome, and TTCR ≥12 months is considered a negative outcome. Accordingly, patients with TTCR \<12 months are positive patients, and those with TTCR ≥12 months are negative patients. The number of correctly predicted positive slides (TTCR\<12 months), to be divided by the number of positive slides in total

Time frame
For each enrolled patient, the predictive results of AI model will be obtained in not long after prostate biopsy, and the sensitivity of the AI model will be evaluated through study completion, an average of 3 year.
2

specificity

The output of the predictive model is divided into a binary variable using a 12-month threshold: TTCR \<12 months is considered a positive outcome, and TTCR ≥12 months is considered a negative outcome. Accordingly, patients with TTCR \<12 months are positive patients, and those with TTCR ≥12 months are negative patients. The number of correctly predicted negative slides (TTCR≥12 months), to be divided by the number of negative slides in total

Time frame
For each enrolled patient, the predictive results of AI model will be obtained in not long after prostate biopsy, and the specificity of the AI model will be evaluated through study completion, an average of 3 year.

Other outcomes

Sponsors and contacts

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