Organoid, Prostate Cancer
Conditions
Brief summary
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.
Detailed description
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;The final medication regimen for patients is determined by doctors based on their experience and in vitro drug sensitivity results. The actual clinical efficacy of medication is tracked for patients, and the organoid chip drug sensitivity detection model is analyzed as a predictor of the sensitivity, specificity, and accuracy of anti-tumor chemotherapy drugs, providing data reference for clinical applications.At the same time, analyze the accuracy of drug sensitivity testing results and clinical empirical medication.If patients are treated with a chemotherapy combined with immunotherapy regimen, the in vitro sensitivity of immune drugs will be determined using organoid-immune co-culture technology, and exploratory research on the predictive performance of immune models will be conducted in conjunction with clinical medication.
Interventions
OTHERBuilding Organoid-on-chips models
This project obtains surgical or biopsy samples from prostate cancer patients with visceral metastasis for the construction of organoids.
Sponsors
Tianjin Medical University Second Hospital
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
MALE
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Patients with visceral metastasis of prostate cancer diagnosed clinically or pathologically; 2. Age ≥ 18 years old; 3. ECOG score ≤ 2 points or ECOG score 3-4 points due to tumor progression; 4. 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; 5. Can obtain surgical or biopsy samples; 6. Patients voluntarily join this study and sign an informed consent form.
Exclusion criteria
1. 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; 2. Patients who are unable to obtain tissue samples; 3. Subjects with active pulmonary tuberculosis (TB); 4. Subjects who are preparing for or have previously undergone tissue/organ transplantation; 5.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Clinical Consistency | 18 months | Sensitivity, specificity, and accuracy of drug sensitivity testing results based on successfully constructed organoids for predicting the main clinical efficacy evaluation indicators. |
| ORR(Objective Response Rate) | 18 months | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Changes in tumor markers levels | 18 months | 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) | 18 months | 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. |
Countries
China
Contacts
Primary ContactHaitao Wang, Ph.D
Backup ContactJinhuan Wang, Ph.D
Outcome results
None listed