Prostatic NeoplasmOrMeProNCT03952793
Organoids From Metastases of Prostate Cancer
A study testing extended biopsy in people with Prostatic Neoplasm, run by Centre Antoine Lacassagne at 1 site in France.
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. Read more about this study
- Who is it for?
- Ages 18 years and older, men only
- Conditions the study is for
- Prostatic Neoplasm
- What is being tested?
- extended biopsy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1 participants
- Where
- 1 siteFrance
- Study dates
- 4 Dec 2019to 25 Oct 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Development of the Organoids Technique From Metastases From Patients With Advanced Form of Prostate Cancer: Use in Basic Research
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
- Being tested
- extended biopsy
- Medical subject headings
- Prostatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
extended biopsyOther
Additional sample are performed during a biopsy to provide tumor tissues for the organoid technique development
| Study group | Role | What they receive |
|---|---|---|
| Experimental | Experimental | Extended biopsy Receives: Other: extended biopsy |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 15 days
Secondary outcomes (3)
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
Measured: 20 days
Cell Apoptosis Molecular and cellular mechanisms of drugs responses
Apoptosis biomarkers analysis in microscopy. Caspase 3 will be assess using microspcopy .
Measured: 20 days
Cell proliferation Molecular and cellular on mechanisms of drugs responses
Proliferative biomarkers analysis in microscopy. Ki67 will be assess using microspcopy .
Measured: 20 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 May 2019
- Study start4 Dec 2019
- Primary completion25 Oct 2021
- Study completion25 Oct 2021
Why it stopped: Feasibility issues
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Prostatic NeoplasmStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 1 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Antoine Lacassagne
- Sponsor type
- University, hospital or other
- Collaborators
- Centre Méditerranéen de Médecine Moléculaire UMR_S-1065
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03952793
- Sponsor's protocol ID
- 2018/63
- Acronym
- OrMePro
- Status last verified
- Oct 2021
- First submitted
- 10 May 2019
- Last updated
- 1 Nov 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Nov 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Development of the Organoids Technique From Metastases From Patients With Advanced Form of Prostate Cancer: Use in Basic Research
- ClinicalTrials.gov ID
- NCT03952793
- Acronym / sponsor ID
- OrMePro / 2018/63
- Conditions
- Prostatic Neoplasm
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Feasibility issues
- Enrolment
- 1 participants (actual)
- Lead sponsor
- Centre Antoine LacassagneUniversity, hospital or other
- Collaborators
- Centre Méditerranéen de Médecine Moléculaire UMR_S-1065
- Study start
- 4 Dec 2019 (actual)
- Primary completion
- 25 Oct 2021 (actual)
- Study completion
- 25 Oct 2021 (actual)
- First posted
- 16 May 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Experimental | Experimental | Other: extended biopsyExtended biopsy |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| extended biopsyAdditional sample are performed during a biopsy to provide tumor tissues for the organoid technique development | Other | Experimental |
Primary outcome
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
3 secondary outcomes
Drugs testing on organoid for cell viability
Time frame: 20 days
Cell Apoptosis Molecular and cellular mechanisms of drugs responses
Time frame: 20 days
Cell proliferation Molecular and cellular on mechanisms of drugs responses
Time frame: 20 days
Results and safety
The study was stopped early (reason given: Feasibility issues). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Nov 2021.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing extended biopsy in people with Prostatic Neoplasm, run by Centre Antoine Lacassagne at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 1 Nov 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: Feasibility issues). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Success rate of establishment of the organoid culture (time frame: 15 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Nov 2021.