Search for Predictive Factors of Resistance to Treatment for Metastatic Castration-resistant Prostate Cancer by Studying the Expression of microRNAs

Study Overview
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Brief Summary
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Several drugs are available for metastatic castration resistant prostate cancer such as chemotherapy (docetaxel, cabazitaxel) and novel hormonal agents (abiraterone, enzalutamide), in France. The oncologist has to choose between those two type of treatment, without any biological predictor of efficacy for his patient. It is always difficult to choose knowing that 30 to 50% of patients won't benefit from the treatment chosen. It shows why resistant mechanisms to treatment need to be elucidated. MicroRNA (miR) are short RNA, implicated in messenger ribonucleic acid (mRNA) regulation. Evidence is emerging that miR is implicated in prostate cancer response to treatment. It would be interesting to determine if a miR profile can predict treatment response to chemotherapy and/or to novel hormonal agents.

Detailed Description
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Several drugs are available for metastatic castration resistant prostate cancer such as chemotherapy (docetaxel, cabazitaxel) and novel hormonal agents (abiraterone, enzalutamide), in France. The oncologist has to choose between those two type of treatment, without any biological predictor of efficacy for his patient. It is always difficult to choose knowing that 30 to 50% of patients won't benefit from the treatment chosen. It shows why resistant mechanisms to treatment need to be elucidated. MicroRNA (miR) are short RNA, implicated in messenger ribonucleic acid (mRNA) regulation. Evidence is emerging that miR is implicated in prostate cancer response to treatment. It would be interesting to determine if a miR profile can predict treatment response to chemotherapy and/or to novel hormonal agents.

Official Title
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Search for Predictive Factors of Resistance to Treatment for Metastatic Castration-resistant Prostate Cancer by Studying the Expression of microRNAs

Conditions
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Prostate Cancer, Resistance, Disease, MicroRNAs

Intervention / Treatment
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* Biological: Blood sample


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: prostate adenocarcinoma metastatic disease, proven (CT or bone scintigraphy or MRI or positron emission tomography(PET)-CT or X ray) castration resistance, proven with biology or radiologic progression affiliated to a french social security regimen Exclusion Criteria: other cancer within five years any judiciary protection measure

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Intervention: blood sample at inclusion. primary purpose: to better understand resistance mechanisms to prostate cancer treatment.
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1- Chemotherapy<br>Intervention : one blood sample is done before beginning chemotherapy as a first treatment line for a metastatic castration resistant prostate cancer | Biological: Blood sample<br>* one blood sample is done before beginning a first treatment line for a metastatic castration resistant prostate cancer<br>|
| Experimental: 2- Novel Hormonal Agent<br>Intervention : one blood sample is done before beginning a novel hormonal agent (abiraterone, enzalutamide) as a first treatment line for a metastatic castration resistant prostate cancer | Biological: Blood sample<br>* one blood sample is done before beginning a first treatment line for a metastatic castration resistant prostate cancer<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| miRNA and chemotherapy | miRNA expression profile predicting resistance to chemotherapy | 30 months | 
| miRNA and novel hormonal agent (NHA) | miRNA expression profile predicting resistance to novel hormonal agents | 30 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| miRNA and progression free survival (PFS) | correlation between miRNA profile and progression free survival | 30 months | 
| miRNA and overall survival (OS) | correlation between miRNA profile and overall survival | 30 months | 
| miRNA in tissue sample | comparison between miRNA expression in serum and in tumoral tissue | 30 months |