Artificial Intelligence Models for Precision Prediction and Treatment of Prostate Cancer

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexMale
Age30+
SponsorShao Pengfei

About this trial

The aim of this clinical trial is whether artificial intelligence models can be used for accurate clinical preoperative diagnosis and postoperative diagnosis of pathological findings, and will also measure the accuracy of the predictions made by the artificial intelligence models.The main target questions addressed by the model building are:

1. whether the AI model can learn from preoperative MRI and postoperative Whole Slide Images so as to accurately predict information such as benignness or malignancy, aggressiveness, grading, subtypes, genes, etc. for participants suspected of having prostate cancer preoperatively/puncturally. 2. whether the AI model is capable of learning postoperative macropathology slides to enable outcome diagnosis of surgical pathology slides in new participants.

Participants will:

1. complete an MRI examination and have their MRI images analysed by the established AI model to make an accurate diagnosis of them. 2. Based on the diagnosis, if prostate cancer is predicted, they will undergo radical prostate cancer surgery and refine their surgical pathology.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

Patients with suspected PCa (elevated PSA or suspicious positive lesions on ultrasound or MRI results);

Disqualifiers

Previous treatment of the prostate in any form, including surgery, radiotherapy/chemotherapy, endocrine therapy, targeted therapy and immunotherapy;

Patients with any item missing from the baseline clinical and pathological information;

Patients with a history of other malignancies, serious comorbidities or other health problems;

Unable to provide/sign an informed consent form;

Trial design

Design model

Parallel

Treatments tested in this trial

  • Accurate Prediction Artificial Intelligence Models

    Diagnostic test

    Diagnostic Test: Accurate Prediction Artificial Intelligence Models Post-operative pathology, precise pre-operative diagnosis (including benign and malignant, invasive, grading, subtypes) or 3D lesion modelling will be predicted based on the AI predictive model in response to the information provided

Treatment groups

200 Participants
are divided into 2 treatment groups
Group A: Experimental groupExperimental treatment 1 intervention
Group B: Control GroupNo intervention 0 interventions

Trial outcomes

Primary outcomes

1

Prediction of postradical prostate cancer pathology after radical prostatectomy using the 'AUC' comprehensive assessment model

'AUC' refers to the area under the ROC (Receiver Operating Characteristic) curve, which indicates the performance of the model in predicting immunohistochemistry-related pathological information of prostate cancer after surgery, and the AUC ranges from 0-1, with the larger value indicating the better prediction effect.

Time frame
From subject enrolment to initial post-surgery, usually 30-90 days.
2

Predicting the performance of post-radical pathology by the 'AUC' comprehensive assessment model

'AUC' refers to the area under the ROC (Receiver Operating Characteristic) curve, indicating the level of performance of the model in predicting prostate cancer in the preoperative period, with AUC ranging from 0-1, with larger values indicating better prediction results.

Time frame
From subject enrolment to initial post-surgery, usually 30-90 days.
3

'F1 Score' to assess performance of preoperative 3D modelling

A reconciled average of the preoperative 3D modelling precision and recall assessed through the 'F1 score', which represents the match to the real situation.

Time frame
From subject enrolment to initial post-surgery/puncture recovery, usually 30-90 days.

Secondary outcomes

1

Assess the amount of cost difference between the predictive model and the clinical approach by "economic cost savings"

Compare the difference in costs incurred using a predictive model with those predicted using a clinical approach, the difference will be in yuan.

Time frame
From subject enrolment to initial post-surgery/puncture recovery, usually 30-90 days.
2

"Diagnostic Time" evaluate the time taken to predict immunohistochemistry-related pathology in the postoperative period.

The time spent postoperatively predicting or assisting the pathologist in obtaining immunohistochemistry-related pathology information is assessed by "Diagnostic Time" and will be measured in minutes.

Time frame
From subject enrolment to initial post-surgery/puncture recovery, usually 30-90 days.

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Shao Pengfei

Lead sponsor

The First Affiliated Hospital with Nanjing Medical University

Sponsor institution

Institute of Automation, Chinese Academy of Sciences

Collaborator

This trial is not recruiting at the moment. You can still explore other options: