Organoids From Metastases of Prostate Cancer

NCT03952793 | Terminated

• 1 other identifier: 2018/63
• Study Type: interventional
• Target: 1
• Locations: 1 country
• Sites: 1

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.

Conditions

Prostatic Neoplasm

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• Drugs testing on organoid for cell viability

  20 days

• Cell Apoptosis Molecular and cellular mechanisms of drugs responses

  20 days

• Cell proliferation Molecular and cellular on mechanisms of drugs responses

  20 days

Study Arms (1)

Experimental

EXPERIMENTAL

Extended biopsy

Other: extended biopsy

Interventions

extended biopsy OTHER

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

Experimental

Eligibility Criteria

• Age: 18 Years+
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Centre Antoine Lacassagne: lead
• Centre Méditerranéen de Médecine Moléculaire UMR_S-1065: collaborator

Study Sites (1)

Centre Antoine Lacassagne

Nice, 06189, France

Location

MeSH Terms

Conditions

Prostatic Neoplasms

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 10, 2019
• First Posted: May 16, 2019
• Study Start: December 4, 2019
• Primary Completion: October 25, 2021
• Study Completion: October 25, 2021
• Last Updated: November 1, 2021

Record last verified: 2021-10

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)