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

Not Applicable

Active, not recruiting

• Conditions: Prostate Cancer; Resistance, Disease; MicroRNAs
• Interventions: Biological: Blood sample

• Registration Number: NCT04662996
• Lead Sponsor: University Hospital, Tours

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.

Study Timeline

• Study First Submitted: 2020-12-03
• Study First Submitted QC: 2020-12-03
• Study First Posted: 2020-12-10
• Study Start: 2021-06-23
• Status Verified: 2023-11
• Last Update Submitted: 2023-11-28
• Last Update Posted: 2023-11-29
• Primary Completion: 2023-11-30
• Study Completion: 2023-11-30

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: Male
• Target Recruitment: 33

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
2- Novel Hormonal Agent	Blood sample	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
1- Chemotherapy	Blood sample	Intervention : one blood sample is done before beginning chemotherapy as a first treatment line for a metastatic castration resistant prostate cancer

Primary Outcome Measures

Name	Time	Method
miRNA and novel hormonal agent (NHA)	30 months	miRNA expression profile predicting resistance to novel hormonal agents
miRNA and chemotherapy	30 months	miRNA expression profile predicting resistance to chemotherapy

Secondary Outcome Measures

Name	Time	Method
miRNA and progression free survival (PFS)	30 months	correlation between miRNA profile and progression free survival
miRNA in tissue sample	30 months	comparison between miRNA expression in serum and in tumoral tissue
miRNA and overall survival (OS)	30 months	correlation between miRNA profile and overall survival

Trial Locations

Locations (1)

University Hospital of Tours; 🇫🇷 Tours, France