NCT06387238

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

• Status: Not Yet Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 150 (estimated)
• Sponsor: Peking University First Hospital · Academic / Other
• Sex: Male
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed 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.

Conditions

• Prostate Adenocarcinoma

Interventions

Type	Name	Description
DIAGNOSTIC_TEST	PSMA PET/CT	pre-therapeutic PSMA PET/CT and post-therapeutic PSMA PET/CT after three-month novel endocrine therapy.

Timeline

• Start date: 2024-05-01
• Primary completion: 2025-05-01
• Completion: 2026-06-30
• First posted: 2024-04-29
• Last updated: 2024-04-29