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Organoids From Metastases of Prostate Cancer (OrMePro)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT03952793
Recruitment Status : Not yet recruiting
First Posted : May 16, 2019
Last Update Posted : May 16, 2019
Centre Méditerranéen de Médecine Moléculaire UMR_S-1065
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Prostatic Neoplasm Other: extended biopsy Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 20 participants
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
Estimated Study Start Date : November 2019
Estimated Primary Completion Date : November 2024
Estimated Study Completion Date : November 2024

Resource links provided by the National Library of Medicine

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

Primary Outcome Measures :
  1. Success rate of establishment of the organoid culture [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 20 days ]
    Proliferative biomarkers analysis in microscopy. Ki67 will be assess using microspcopy .

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT03952793

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Contact: Colin DEBAIGT, PhD +33 4 92 03 17 78

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Centre Antoine Lacassagne Active, not recruiting
Nice, France, 06189
Sponsors and Collaborators
Centre Antoine Lacassagne
Centre Méditerranéen de Médecine Moléculaire UMR_S-1065

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Responsible Party: Centre Antoine Lacassagne Identifier: NCT03952793     History of Changes
Other Study ID Numbers: 2018/63
First Posted: May 16, 2019    Key Record Dates
Last Update Posted: May 16, 2019
Last Verified: May 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Genital Diseases, Male
Prostatic Diseases