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Exploration of the Value of PSMA PET/CT in Dynamic Monitoring of the Efficacy of Novel Endocrine Therapy in Patients With Metastatic Hormone Sensitive Prostate Cancer

Prostate Adenocarcinoma Clinical Trial

Official title:
Exploration of the Value of PSMA PET/CT in Dynamic Monitoring of the Efficacy of Novel Endocrine Therapy in Patients With Metastatic Hormone Sensitive Prostate Cancer

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

Clinical Trial Details
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
View Details
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