Clinical trial 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
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
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Prostate Adenocarcinoma
Lead sponsor: Peking University First Hospital
Sponsor class: OTHER
First posted: 2024-04-29
Enrollment: 150
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: 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.
Primary purpose: DIAGNOSTIC

Brief 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.

Eligibility criteria: 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).

      * Patient age\>18 years old.

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.

Primary outcomes:
measure: rPFS
timeFrame: 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.
Secondary outcomes:
measure: PSA-PFS
timeFrame: 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.
measure: OS
timeFrame: From date of enrollment treatment until the date of death from any cause, assessed up to 12 months.
Other outcomes:
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