Prostate CancerProstate Intraductal CarcinomaProstate Cancer AggressivenessProstate Cancer StagePathology
Investigational drug(s) / intervention(s)
Accurate Prediction Artificial Intelligence Models
Accurate Prediction Artificial Intelligence Models: 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
Study summary
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
Sex
MALE
Min age
30 Years
Max age
—
Healthy volunteers
Accepted
Inclusion Criteria:
* Patients with suspected PCa (elevated PSA or suspicious positive lesions on ultrasound or MRI results);
Exclusion Criteria:
* 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;
* Patients who, in the judgement of the investigator, are deemed unfit to participate in this clinical trial;
Primary outcome measure(s)
Prediction of postradical prostate cancer pathology after radical prostatectomy using the 'AUC' comprehensive assessment model — From subject enrolment to initial post-surgery, usually 30-90 days. '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.
Predicting the performance of post-radical pathology by the 'AUC' comprehensive assessment model — From subject enrolment to initial post-surgery, usually 30-90 days. '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.
'F1 Score' to assess performance of preoperative 3D modelling — From subject enrolment to initial post-surgery/puncture recovery, usually 30-90 days. A reconciled average of the preoperative 3D modelling precision and recall assessed through the 'F1 score', which represents the match to the real situation.
Trial sites (1)
Facility
City
Region
Status
The First Affiliated Hospital of Nanjing Medical University (Jiangsu Provincial People's Hospital)
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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