Observation of Clinical Consistency of Organoid-chips Drug Sensitivity in Chemotherapy for PCa With Visceral Metastasis

Observation of Clinical Consistency of Organoid-on-chips Drug Sensitivity Detection in Chemotherapy for Prostate Cancer Patients With Visceral Metastasis

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.

Study Overview

• Status: Recruiting
• Conditions: Prostate Cancer; Organoid
• Intervention / Treatment: Other: Building Organoid-on-chips models

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.

• Study Type: Observational
• Enrollment (Estimated): 35

Contacts and Locations

• Study Contact: Name: Haitao Wang, Ph.D; Phone Number: +86-022-88326385; Email: peterrock2000@126.com
• Study Contact Backup: Name: Jinhuan Wang, Ph.D; Phone Number: +86-022-88326610; Email: wjhhappy2008@163.com

Study Locations

• China
  • Tianjin
    • Tianjin, Tianjin, China
      • Recruiting
      • Tianjin Medical Unversity Second Hospital
      • Contact: Haitao Wang, Ph.D; Phone Number: +86-022-88326385; Email: peterrock2000@126.com
      • Sub-Investigator: Lei Wang
      • Sub-Investigator: Lili Wang
      • Sub-Investigator: Dingkun Hou
      • Principal Investigator: Haitao Wang
      • Sub-Investigator: Jinhuan Wang
      • Contact: Lili Wang, MM; Phone Number: +86-022-88326610; Email: wangliliaigang@163.com
    • Tianjin, Tianjin, China, 300211
      • Recruiting
      • Tianjin Medical Unversity Second Hospital
      • Sub-Investigator: Lili Wang
      • Sub-Investigator: Dingkun Hou
      • Principal Investigator: Haitao Wang
      • Sub-Investigator: Jinhuan Wang
      • Contact: Haitao Wang; Phone Number: +86-02288326610; Email: peterrock2000@126.com
      • Contact: Lili Wang; Phone Number: +86-13516108466; Email: wangliliaigang@163.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Prostate Cancer Patients With Visceral Metastasis

Description

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.

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
PCa Patients With Visceral Metastasis; Prostate cancer patients with visceral metastasis.	Other: Building Organoid-on-chips models; This project obtains surgical or biopsy samples from prostate cancer patients with visceral metastasis for the construction of organoids.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	18 months
Clinical Consistency	Sensitivity, specificity, and accuracy of drug sensitivity testing results based on successfully constructed organoids for predicting the main clinical efficacy evaluation indicators.	18 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	18 months
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.	18 months

Collaborators and Investigators

• Sponsor: Tianjin Medical University Second Hospital

Study record dates

Study Major Dates

• Study Start (Actual): June 1, 2024
• Primary Completion (Estimated): November 1, 2025
• Study Completion (Estimated): December 31, 2025

Study Registration Dates

• First Submitted: July 30, 2024
• First Submitted That Met QC Criteria: August 2, 2024
• First Posted (Estimated): August 5, 2024

Study Record Updates

• Last Update Posted (Estimated): August 5, 2024
• Last Update Submitted That Met QC Criteria: August 2, 2024
• Last Verified: August 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Genital Neoplasms, Male; Prostatic Diseases; Urogenital Diseases; Male Urogenital Diseases; Genital Diseases, Male; Genital Diseases; Prostatic Neoplasms
• Other Study ID Numbers: Organoid-on-chips-PCa

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No