Clinical trial

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

Name
DR200300 _MiR_CPMRC
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.
Trial arms
Trial start
2021-06-23
Estimated PCD
2023-11-30
Trial end
2023-11-30
Status
Active (not recruiting)
Treatment
Blood sample
one blood sample is done before beginning a first treatment line for a metastatic castration resistant prostate cancer
Arms:
1- Chemotherapy, 2- Novel Hormonal Agent
Size
33
Primary endpoint
miRNA and chemotherapy
30 months
miRNA and novel hormonal agent (NHA)
30 months
Eligibility criteria
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
Protocol
{'studyType': 'INTERVENTIONAL', 'phases': ['NA'], 'designInfo': {'allocation': 'NON_RANDOMIZED', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Intervention: blood sample at inclusion. primary purpose: to better understand resistance mechanisms to prostate cancer treatment.', 'primaryPurpose': 'OTHER', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}}, 'enrollmentInfo': {'count': 33, 'type': 'ACTUAL'}}
Updated at
2023-11-29

1 organization

4 indications

Indication
Prostate Cancer
Indication
Disease
Indication
miRNAs