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Trial 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
NCT ID:
NCT06387238
Condition:
Prostate Adenocarcinoma
Conditions: Official terms:
Adenocarcinoma
Study type:
Interventional
Study phase:
N/A
Overall status:
Not yet recruiting
Study design:
Allocation:
N/A
Intervention model:
Single Group Assignment
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
Masking:
None (Open Label)
Intervention:
Intervention type:
Diagnostic Test
Intervention name:
PSMA PET/CT
Description:
pre-therapeutic PSMA PET/CT and post-therapeutic PSMA PET/CT after three-month novel
endocrine therapy.
Arm group label:
mHSPC-PSMA
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.
Criteria for 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.
Gender:
Male
Gender based:
Yes
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Start date:
May 1, 2024
Completion date:
June 30, 2026
Lead sponsor:
Agency:
Peking University First Hospital
Agency class:
Other
Source:
Peking University First Hospital
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06387238
