Organoids From Metastases of Prostate Cancer

Prostatic Neoplasm Clinical Trial

— OrMePro  

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT03952793
• Other study ID #: 2018/63
• Status: Terminated
• Phase: N/A
• Start date: December 4, 2019
• Est. completion date: October 25, 2021

Study information

• Verified date: October 2021
• Source: Centre Antoine Lacassagne
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 1
• Est. completion date: October 25, 2021
• Est. primary completion date: October 25, 2021
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Prostatic Neoplasm
• Prostatic Neoplasms

Intervention

Other:
• extended biopsy
Additional sample are performed during a biopsy to provide tumor tissues for the organoid technique development

Locations

Country	Name	City	State
France	Centre Antoine Lacassagne	Nice

Sponsors (2)

Lead Sponsor	Collaborator
Centre Antoine Lacassagne	Centre Me´diterrane´en de Me´decine Mole´culaire UMR_S-1065

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	Cell Apoptosis Molecular and cellular mechanisms of drugs responses	Apoptosis biomarkers analysis in microscopy. Caspase 3 will be assess using microspcopy .	20 days
Secondary	Cell proliferation Molecular and cellular on mechanisms of drugs responses	Proliferative biomarkers analysis in microscopy. Ki67 will be assess using microspcopy .	20 days