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

NCT06536725 | Recruiting

• 1 other identifier: Organoid-on-chips-PCa
• Study Type: observational
• Target: 35
• Locations: 1 country
• Sites: 2

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.

Conditions

Prostate Cancer; Organoid

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (2)

• Changes in tumor markers levels

  18 months

• PFS(Progression-free survival)

  18 months

Study Arms (1)

PCa Patients With Visceral Metastasis

Prostate cancer patients with visceral metastasis.

Other: Building Organoid-on-chips models

Interventions

Building Organoid-on-chips models OTHER

This project obtains surgical or biopsy samples from prostate cancer patients with visceral metastasis for the construction of organoids.

PCa Patients With Visceral Metastasis

Eligibility Criteria

• Age: 18 Years+
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Prostate Cancer Patients With Visceral Metastasis

You may qualify if:

• 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;
• Can obtain surgical or biopsy samples;
• Patients voluntarily join this study and sign an informed consent form.

You may not qualify if:

• 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;

Sponsors & Collaborators

• Tianjin Medical University Second Hospital: lead

Study Sites (2)

Tianjin Medical Unversity Second Hospital

Tianjin, Tianjin Municipality, 300211, China

RECRUITING

Tianjin Medical Unversity Second Hospital

Tianjin, Tianjin Municipality, China

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

These samples are used for NGS detection

MeSH Terms

Conditions

Prostatic Neoplasms

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases

Central Study Contacts

Haitao Wang, Ph.D

CONTACT

+86-022-88326385; peterrock2000@126.com

Jinhuan Wang, Ph.D

CONTACT

+86-022-88326610; wjhhappy2008@163.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 30, 2024
• First Posted: August 5, 2024
• Study Start: June 1, 2024
• Primary Completion: November 1, 2025
• Study Completion: December 31, 2025
• Last Updated: August 5, 2024

Record last verified: 2024-08

Locations

CN (2)