This project plans to establish an organoid chip model of prostate cancer patients with internal organ metastasis from surgical or biopsy tissue sources, and test the sensitivity of commonly used chemotherapy drugs based on organoid chip drug sensitivity testing technology to screen out sensitive individualized treatment plans.
Patients with visceral metastasis of prostate cancer diagnosed clinically or pathologically;
Age ≥ 18 years old;
ECOG score ≤ 2 points or ECOG score 3-4 points due to tumor progression;
Normal liver and kidney function, serum transaminase ALT<66 U/L, AST<36 U/L, total bilirubin<22 umol/L, creatinine<106 umol/L, urea nitrogen<6.1 mmol/L; Normal bone marrow function: neutrophil count ≥ 1800/mm3 and platelet count ≥ 100000/mm3;
Patients with severe heart, liver, kidney, and peripheral nervous system diseases, as well as autoimmune diseases such as hyperthyroidism and hypothyroidism; Systemic lupus erythematosus, etc;
Patients who are unable to obtain tissue samples;
Subjects with active pulmonary tuberculosis (TB);
Subjects who are preparing for or have previously undergone tissue/organ transplantation;
Prostate Cancer Patients With Visceral Metastasis
Cohort
Prospective
Building Organoid-on-chips models
Other interventionThis project obtains surgical or biopsy samples from prostate cancer patients with visceral metastasis for the construction of organoids.
ORR(Objective Response Rate)
Selecting ORR as the primary endpoint from clinical efficacy evaluation indicators.Evaluation of the best objective response rate (ORR) for each treatment according to RECIST 1.1. The best ORR is the best response reached during treatment according to RECIST 1.1 criteria.
Clinical Consistency
Sensitivity, specificity, and accuracy of drug sensitivity testing results based on successfully constructed organoids for predicting the main clinical efficacy evaluation indicators.
Changes in tumor markers levels
The main tumor marker monitored is TPSA.The levels of PSA will be monitored every 3 (or 4) weeks for comparison to baseline levels until the time of PSA progression, as defined by PCWG3 criteria.The levels of other tumor markers will be monitored every 3 (or 4) weeks for comparison to baseline levels until the time of tumor markers progression.
PFS(Progression-free survival)
Progression-free survival (PFS) is defined as the time from the date of the first administration of patients medication plan based on organoids drug sensitivity test to the date of the first documentation of disease progression or death due to any cause, whichever comes first, censored at the last date at which the participant was determined to be progression-free.
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