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

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 Overview

• Status: Completed
• Conditions: Prostate Cancer; Resistance, Disease; MicroRNAs
• Intervention / Treatment: Biological: Blood sample

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 Type: Interventional
• Enrollment (Actual): 33
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Tours, France, 37044
    • University hospital of Tours

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 1- Chemotherapy; Intervention : one blood sample is done before beginning chemotherapy as a first treatment line for a metastatic castration resistant prostate cancer	Biological: Blood sample; one blood sample is done before beginning a first treatment line for a metastatic castration resistant prostate cancer
Experimental: 2- Novel Hormonal Agent; 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; one blood sample is done before beginning a first treatment line for a metastatic castration resistant prostate cancer

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: University Hospital, Tours
• Investigators: Study Director: Mathilde CANCEL, MD, University Hospital, Tours

Publications and helpful links

General Publications

• Huang X, Yuan T, Liang M, Du M, Xia S, Dittmar R, Wang D, See W, Costello BA, Quevedo F, Tan W, Nandy D, Bevan GH, Longenbach S, Sun Z, Lu Y, Wang T, Thibodeau SN, Boardman L, Kohli M, Wang L. Exosomal miR-1290 and miR-375 as prognostic markers in castration-resistant prostate cancer. Eur Urol. 2015 Jan;67(1):33-41. doi: 10.1016/j.eururo.2014.07.035. Epub 2014 Aug 14.
• Razdan A, de Souza P, Roberts TL. Role of MicroRNAs in Treatment Response in Prostate Cancer. Curr Cancer Drug Targets. 2018;18(10):929-944. doi: 10.2174/1568009618666180315160125.
• Lin HM, Castillo L, Mahon KL, Chiam K, Lee BY, Nguyen Q, Boyer MJ, Stockler MR, Pavlakis N, Marx G, Mallesara G, Gurney H, Clark SJ, Swarbrick A, Daly RJ, Horvath LG. Circulating microRNAs are associated with docetaxel chemotherapy outcome in castration-resistant prostate cancer. Br J Cancer. 2014 May 13;110(10):2462-71. doi: 10.1038/bjc.2014.181. Epub 2014 Apr 8.
• Zhang G, Tian X, Li Y, Wang Z, Li X, Zhu C. miR-27b and miR-34a enhance docetaxel sensitivity of prostate cancer cells through inhibiting epithelial-to-mesenchymal transition by targeting ZEB1. Biomed Pharmacother. 2018 Jan;97:736-744. doi: 10.1016/j.biopha.2017.10.163. Epub 2017 Nov 6.
• Fletcher CE, Sulpice E, Combe S, Shibakawa A, Leach DA, Hamilton MP, Chrysostomou SL, Sharp A, Welti J, Yuan W, Dart DA, Knight E, Ning J, Francis JC, Kounatidou EE, Gaughan L, Swain A, Lupold SE, de Bono JS, McGuire SE, Gidrol X, Bevan CL. Androgen receptor-modulatory microRNAs provide insight into therapy resistance and therapeutic targets in advanced prostate cancer. Oncogene. 2019 Jul;38(28):5700-5724. doi: 10.1038/s41388-019-0823-5. Epub 2019 May 1.

Study record dates

Study Major Dates

• Study Start (Actual): June 23, 2021
• Primary Completion (Actual): November 30, 2022
• Study Completion (Actual): November 30, 2023

Study Registration Dates

• First Submitted: December 3, 2020
• First Submitted That Met QC Criteria: December 3, 2020
• First Posted (Actual): December 10, 2020

Study Record Updates

• Last Update Posted (Actual): February 12, 2026
• Last Update Submitted That Met QC Criteria: February 9, 2026
• Last Verified: February 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Urogenital Diseases; Genital Diseases; Pathologic Processes; Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Prostatic Diseases; Male Urogenital Diseases; Disease Attributes; Pathological Conditions, Signs and Symptoms; Prostatic Neoplasms; Disease Resistance; Investigative Techniques; Specimen Handling; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Punctures; Surgical Procedures, Operative; Blood Specimen Collection
• Other Study ID Numbers: DR200300 _MiR_CPMRC; 2020-A03304-35 (Registry Identifier: ANSM)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No