Organoids From Metastases of Prostate Cancer

Not Applicable

Terminated

• Conditions: Prostatic Neoplasm
• Interventions: Other: extended biopsy

• Registration Number: NCT03952793
• Lead Sponsor: Centre Antoine Lacassagne

Brief Summary

The aim of the study is the development of the organoid culture technique from metastases from patients with advanced form of prostate cancer. Once the technique is set up, the organoid will serve to test several antitumor molecules.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2019-05-10
• Study First Submitted QC: 2019-05-15
• Study First Posted: 2019-05-16
• Study Start: 2019-12-04
• Status Verified: 2021-10
• Primary Completion: 2021-10-25
• Study Completion: 2021-10-25
• Last Update Submitted: 2021-10-25
• Last Update Posted: 2021-11-01

Recruitment & Eligibility

• Status: TERMINATED
• Sex: Male
• Target Recruitment: 1

Inclusion Criteria

• Patient with metastatic prostate cancer
• Patient having a biopsy programmed as part of his care.
• Patient having a biopsy programmed as part of hiscare.
• Patient with sufficient tumor volume after imaging data review by the radiologist to guarantee a sufficient quantity of material for the diagnosis of biopsy and additional material for the study.
• INR <1.5; Platelets > 50000 / μL

Exclusion Criteria

• Patient under age of 18 years.
• Patient under Plavix or Effient or Ticlid without possibility of suspension for 5 days, low molecular weight heparin without possibility of suspension of the dose before the intervention, or Fondaparinux without possibility of suspension, or ReoPro without possibility of suspension for 24h and aPTT <50s and ACT <150s, or Integrilin or Aggrastat or Argatroban without possibility of suspension 4 H before the intervention, or Angiomax without possibility of suspending 2H to 3H if CrCL> 50 mL / min or 3H to 5h if CrCL <50 mL / min before the intervention or and Pradaxa without possibility of suspension 2 to 3 days if CrCL> 50 mL / min or 3 to 5 days if CrCL <50 mL / min before the procedure
• Patient under desmopressin acetate (DDAVP)
• Patient with HIV or Hepatitis C positive or Hepatitis B infection, defined by either a detection of the HBs antigen or the presence of anti HBc antibodies without HBs antibody detectable.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Experimental	extended biopsy	Extended biopsy

Primary Outcome Measures

Name	Time	Method
Success rate of establishment of the organoid culture	15 days	The success rate is defined by the rate of successful cell culture. A Cell culture is successful when organoids grow from dividing cells

Secondary Outcome Measures

Name	Time	Method
Cell proliferation Molecular and cellular on mechanisms of drugs responses	20 days	Proliferative biomarkers analysis in microscopy. Ki67 will be assess using microspcopy .
Drugs testing on organoid for cell viability	20 days	Viable cell count in different cells culture conditions using Cell titer Glo and viable cell count using typan blue
Cell Apoptosis Molecular and cellular mechanisms of drugs responses	20 days	Apoptosis biomarkers analysis in microscopy. Caspase 3 will be assess using microspcopy .

Trial Locations

Locations (1)

Centre Antoine Lacassagne; 🇫🇷 Nice, France