Back to resultsOrganoids From Metastases of Prostate Cancer (OrMePro)
Primary Purpose
Prostatic Neoplasm
Status
Terminated
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
extended biopsy
Sponsored by
About this trial
This is an interventional basic science trial for Prostatic Neoplasm
Eligibility Criteria
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.
Sites / Locations
- Centre Antoine Lacassagne
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Experimental
Arm Description
Extended biopsy
Outcomes
Primary Outcome Measures
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
Secondary Outcome Measures
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
Cell Apoptosis Molecular and cellular mechanisms of drugs responses
Apoptosis biomarkers analysis in microscopy. Caspase 3 will be assess using microspcopy .
Cell proliferation Molecular and cellular on mechanisms of drugs responses
Proliferative biomarkers analysis in microscopy. Ki67 will be assess using microspcopy .
Full Information
NCT ID
NCT03952793
First Posted
May 10, 2019
Last Updated
October 25, 2021
Sponsor
Centre Antoine Lacassagne
Collaborators
Centre Méditerranéen de Médecine Moléculaire UMR_S-1065
1. Study Identification
Unique Protocol Identification Number
NCT03952793
Brief Title
Organoids From Metastases of Prostate Cancer
Acronym
OrMePro
Official Title
Development of the Organoids Technique From Metastases From Patients With Advanced Form of Prostate Cancer: Use in Basic Research
Study Type
Interventional
2. Study Status
Record Verification Date
October 2021
Overall Recruitment Status
Terminated
Why Stopped
Feasibility issues
Study Start Date
December 4, 2019 (Actual)
Primary Completion Date
October 25, 2021 (Actual)
Study Completion Date
October 25, 2021 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Centre Antoine Lacassagne
Collaborators
Centre Méditerranéen de Médecine Moléculaire UMR_S-1065
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Prostatic Neoplasm
7. Study Design
Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
1 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Experimental
Arm Type
Experimental
Arm Description
Extended biopsy
Intervention Type
Other
Intervention Name(s)
extended biopsy
Intervention Description
Additional sample are performed during a biopsy to provide tumor tissues for the organoid technique development
Primary Outcome Measure Information:
Title
Success rate of establishment of the organoid culture
Description
The success rate is defined by the rate of successful cell culture. A Cell culture is successful when organoids grow from dividing cells
Time Frame
15 days
Secondary Outcome Measure Information:
Title
Drugs testing on organoid for cell viability
Description
Viable cell count in different cells culture conditions using Cell titer Glo and viable cell count using typan blue
Time Frame
20 days
Title
Cell Apoptosis Molecular and cellular mechanisms of drugs responses
Description
Apoptosis biomarkers analysis in microscopy. Caspase 3 will be assess using microspcopy .
Time Frame
20 days
Title
Cell proliferation Molecular and cellular on mechanisms of drugs responses
Description
Proliferative biomarkers analysis in microscopy. Ki67 will be assess using microspcopy .
Time Frame
20 days
10. Eligibility
Sex
Male
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Facility Information:
Facility Name
Centre Antoine Lacassagne
City
Nice
ZIP/Postal Code
06189
Country
France
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Organoids From Metastases of Prostate Cancer
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