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Organoids From Metastases of Prostate Cancer

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

Status
Terminated
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03952793
Acronym
OrMePro
Enrollment
1
Registered
2019-05-16
Start date
2019-12-04
Completion date
2021-10-25
Last updated
2021-11-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Prostatic Neoplasm

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.

Interventions

OTHERextended biopsy

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

Sponsors

Centre Méditerranéen de Médecine Moléculaire UMR_S-1065
CollaboratorUNKNOWN
Centre Antoine Lacassagne
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
BASIC_SCIENCE
Masking
NONE

Eligibility

Sex/Gender
MALE
Age
18 Years to No maximum
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.

Design outcomes

Primary

MeasureTime frameDescription
Success rate of establishment of the organoid culture15 daysThe success rate is defined by the rate of successful cell culture. A Cell culture is successful when organoids grow from dividing cells

Secondary

MeasureTime frameDescription
Drugs testing on organoid for cell viability20 daysViable 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 responses20 daysApoptosis biomarkers analysis in microscopy. Caspase 3 will be assess using microspcopy .
Cell proliferation Molecular and cellular on mechanisms of drugs responses20 daysProliferative biomarkers analysis in microscopy. Ki67 will be assess using microspcopy .

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026