Organoids From Metastases of Prostate Cancer (OrMePro)

Development of the Organoids Technique From Metastases From Patients With Advanced Form of Prostate Cancer: Use in Basic Research

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.

Study Overview

• Status: Terminated
• Conditions: Prostatic Neoplasm
• Intervention / Treatment: Other: extended biopsy

• Study Type: Interventional
• Enrollment (Actual): 1
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Nice, France, 06189
    • Centre Antoine Lacassagne

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Male

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Experimental; Extended biopsy	Other: extended biopsy; Additional sample are performed during a biopsy to provide tumor tissues for the organoid technique development

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Centre Antoine Lacassagne
• Collaborators: Centre Méditerranéen de Médecine Moléculaire UMR_S-1065

Study record dates

Study Major Dates

• Study Start (Actual): December 4, 2019
• Primary Completion (Actual): October 25, 2021
• Study Completion (Actual): October 25, 2021

Study Registration Dates

• First Submitted: May 10, 2019
• First Submitted That Met QC Criteria: May 15, 2019
• First Posted (Actual): May 16, 2019

Study Record Updates

• Last Update Posted (Actual): November 1, 2021
• Last Update Submitted That Met QC Criteria: October 25, 2021
• Last Verified: October 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Genital Neoplasms, Male; Prostatic Diseases; Prostatic Neoplasms
• Other Study ID Numbers: 2018/63

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

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