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OrMePro: Organoids From Metastases of Prostate Cancer

Sponsor
Centre Antoine Lacassagne (Other)
Overall Status
Terminated
CT.gov ID
NCT03952793
Collaborator
Centre Méditerranéen de Médecine Moléculaire UMR_S-1065 (Other)
1
Enrollment
1
Location
1
Arm
22.7
Actual Duration (Months)
0
Patients Per Site Per Month

Study Details

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.

Condition or Disease Intervention/Treatment Phase
  • Other: extended biopsy
 N/A

Study Design

Study Type:
Interventional
Actual Enrollment :
1 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Basic Science
Official Title:
Development of the Organoids Technique From Metastases From Patients With Advanced Form of Prostate Cancer: Use in Basic Research
Actual Study Start Date :
Dec 4, 2019
Actual Primary Completion Date :
Oct 25, 2021
Actual Study Completion Date :
Oct 25, 2021

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

  1. 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

  1. 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

  2. Cell Apoptosis Molecular and cellular mechanisms of drugs responses [20 days]

    Apoptosis biomarkers analysis in microscopy. Caspase 3 will be assess using microspcopy .

  3. Cell proliferation Molecular and cellular on mechanisms of drugs responses [20 days]

    Proliferative biomarkers analysis in microscopy. Ki67 will be assess using microspcopy .

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
Male
Accepts Healthy Volunteers:
No
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.

Contacts and Locations

Locations

Site City State Country Postal Code
1 Centre Antoine Lacassagne Nice France 06189

Sponsors and Collaborators

  • Centre Antoine Lacassagne
  • Centre Méditerranéen de Médecine Moléculaire UMR_S-1065

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Centre Antoine Lacassagne
ClinicalTrials.gov Identifier:
NCT03952793
Other Study ID Numbers:
  • 2018/63
First Posted:
May 16, 2019
Last Update Posted:
Nov 1, 2021
Last Verified:
Oct 1, 2021
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:
Prostatic Neoplasms

Study Results

No Results Posted as of Nov 1, 2021