Testing drug sensitivity in prostate cancer using organoid chips
Observation of Clinical Consistency of Organoid-on-chips Drug Sensitivity Detection in Chemotherapy for Prostate Cancer Patients With Visceral Metastasis
This study is testing if a new method using tiny models of prostate cancer can help find the best chemotherapy and immune treatments for patients with advanced cancer.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 35 (estimated) |
| Ages | 18 Years and up |
| Sex | Male |
| Sponsor | Tianjin Medical University Second Hospital Academic / other |
| Drugs / interventions | chemotherapy, immunotherapy |
| Locations | 2 sites (Tianjin, Tianjin Municipality and 1 other locations) |
| Trial ID | NCT06536725 on ClinicalTrials.gov |
What this trial studies
This project aims to create organoid chip models from surgical or biopsy samples of prostate cancer patients with visceral metastasis. It will evaluate the sensitivity of commonly used chemotherapy drugs through organoid chip drug sensitivity testing technology to identify personalized treatment plans. The study will track the clinical efficacy of the medications prescribed based on both the organoid testing results and the physicians' clinical experience. Additionally, it will explore the sensitivity of immune drugs in combination therapies using organoid-immune co-culture technology.
Who should consider this trial
Good fit: Ideal candidates include adults aged 18 and older with clinically or pathologically diagnosed visceral metastasis of prostate cancer.
Not a fit: Patients with severe comorbidities, autoimmune diseases, or those unable to provide tissue samples may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could lead to more effective and personalized chemotherapy treatments for prostate cancer patients with visceral metastasis.
How similar studies have performed: While the use of organoid models in drug sensitivity testing is a growing field, this specific application in prostate cancer with visceral metastasis is relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
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. Exclusion criteria are not listed, but the researchers believe that patients who are not suitable to participate in this clinical study.
Where this trial is running
Tianjin, Tianjin Municipality and 1 other locations
- Tianjin Medical Unversity Second Hospital — Tianjin, Tianjin Municipality, China (Recruiting)
- Tianjin Medical Unversity Second Hospital — Tianjin, Tianjin Municipality, China (Recruiting)
Study contacts
- Study coordinator: Haitao Wang, Ph.D
- Email: peterrock2000@126.com
- Phone: +86-022-88326385
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.