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1. Construction of PSMA PET whole-body tumor burden classification:
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:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| mHSPC-PSMA | Experimental | Patients with mHSPC who will receive pre-therapeutic PSMA PET/CT and post-therapeutic PSMA PET/CT after three-month novel endocrine therapy. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| PSMA PET/CT | Diagnostic Test | pre-therapeutic PSMA PET/CT and post-therapeutic PSMA PET/CT after three-month novel endocrine therapy. |
|
| Measure | Description | Time Frame |
|---|---|---|
| rPFS | radiological progression free survival | From date of enrollment treatment until the date of first documented progression confirmed by radiological examinations or date of death from any cause, whichever came first, assessed up to 12 months. |
| Measure | Description | Time Frame |
|---|---|---|
| PSA-PFS | PSA progression free survival | From date of enrollment treatment until the date of first documented progression confirmed by blood PSA tests or date of death from any cause, whichever came first, assessed up to 12 months. |
| OS |
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Inclusion Criteria:
Prostate cancer patients confirmed to have metastasis by PSMA PET/CT before new endocrine therapy.
Those who have not undergone androgen deprivation treatment in the past, or have currently received androgen deprivation treatment for no more than 120 days without progress, or have received androgen deprivation treatment in the past (treatment time less than 24 months and no progress within 12 months after completion).
Patients with KPS score ≥ 50 (ECOG/WHO equivalent).
Exclusion Criteria:
Patients who cannot understand and voluntarily participate in this trial, donnot sign an informed consent form, and aren't able to cooperate independently in completing the examination.
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Xuhe Liao, Dr | Contact | 0086-10-83575252 | liaoxuhe@bjmu.edu.cn | |
| Hongwei Sun, Dr | Contact | 0086-10-83575252 | lxhxixi@163.com |
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Patients With Metastatic Hormone Sensitive Prostate Cancer, will receive pre-therapeutic PSMA PET/CT and post-therapeutic PSMA PET/CT after three-month novel endocrine therapy.
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overall survival
| From date of enrollment treatment until the date of death from any cause, assessed up to 12 months. |