MicroRNAs, Prostate Cancer, Resistance, Disease
Conditions
Brief summary
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
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.
Interventions
BIOLOGICALBlood sample
one blood sample is done before beginning a first treatment line for a metastatic castration resistant prostate cancer
Sponsors
University Hospital, Tours
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Intervention model description
Intervention: blood sample at inclusion. primary purpose: to better understand resistance mechanisms to prostate cancer treatment.
Eligibility
Sex/Gender
MALE
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| miRNA and chemotherapy | 30 months | miRNA expression profile predicting resistance to chemotherapy |
| miRNA and novel hormonal agent (NHA) | 30 months | miRNA expression profile predicting resistance to novel hormonal agents |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| miRNA and progression free survival (PFS) | 30 months | correlation between miRNA profile and progression free survival |
| miRNA and overall survival (OS) | 30 months | correlation between miRNA profile and overall survival |
| miRNA in tissue sample | 30 months | comparison between miRNA expression in serum and in tumoral tissue |
Countries
France
Contacts
STUDY_DIRECTORMathilde CANCEL, MD
University Hospital, Tours
Outcome results
None listed