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Clinical Trial Summary

1. Based on the treatment response and prognosis of mHSPC patients with novel endocrine therapy, a PSMA PET whole-body tumor burden classification was constructed to guide treatment and evaluate prognosis. 2. Based on the treatment response and prognosis of mHSPC patients with novel endocrine therapy, a multivariable model will be constructed using quantitative parameters of PSMA PET/CT imaging, pre-treatment gene status, PSA, GS/ISUP and other clinical pathological parameters to further achieve accurate patient classification, guide treatment, and evaluate prognosis.


Clinical Trial Description

1. Construction of PSMA PET whole-body tumor burden classification: 1. Assessment of whole-body tumor burden on PSMA PET/CT images of mHSPC patients before new endocrine therapy. 2. PSMA PET/CT imaging evaluation of treatment response of the first three months after start of new endocrine therapy. 3. Based on the response results, the optimal threshold for whole-body tumor burden is obtained through ROC curve analysis, and a preliminary classification of whole-body tumor burden is obtained. Verification 1: Follow up preliminary verification/improvement of this subtype Verification 2: External verification, reverifying the predictive performance of typing through the verification cohort. 2. Construction of multivariable predictive model for mHSPC patients with novel endocrine therapy: 1. Molecular imaging parameter measurement and collection of PSMA PET/CT images of mHSPC patients of 3 months after the start of new endocrine therapy. 2. Complete pre-treatment genetic testing, dynamic evaluation of serum PSA before and after treatment, and collection of clinical and pathological information. 3. Based on follow-up results, construct a multi factor model, screen significant factors, and achieve a predictive model for novel endocrine therapy in mHSPC patients Verification: External verification, verifying the predictive performance of the model through the verification cohort. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT06387238
Study type Interventional
Source Peking University First Hospital
Contact Xuhe Liao, Dr
Phone 0086-10-83575252
Email liaoxuhe@bjmu.edu.cn
Status Not yet recruiting
Phase N/A
Start date May 1, 2024
Completion date June 30, 2026

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