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

Prostate Cancer Clinical Trial

— MiR_CPMRC  

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04662996
• Other study ID #: DR200300 _MiR_CPMRC
• Secondary ID: 2020-A03304-35
• Status: Active, not recruiting
• Phase: N/A
• Start date: June 23, 2021
• Est. completion date: November 30, 2023

Study information

• Verified date: November 2023
• Source: University Hospital, Tours
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 33
• Est. completion date: November 30, 2023
• Est. primary completion date: November 30, 2023
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• MicroRNAs
• Prostate Cancer
• Prostatic Neoplasms
• Resistance, Disease

Intervention

Biological:
• Blood sample
one blood sample is done before beginning a first treatment line for a metastatic castration resistant prostate cancer

Locations

Country	Name	City	State
France	University Hospital of Tours	Tours

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Tours

Country where clinical trial is conducted

France, 

References & Publications (5)

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	miRNA and chemotherapy	miRNA expression profile predicting resistance to chemotherapy	30 months
Primary	miRNA and novel hormonal agent (NHA)	miRNA expression profile predicting resistance to novel hormonal agents	30 months
Secondary	miRNA and progression free survival (PFS)	correlation between miRNA profile and progression free survival	30 months
Secondary	miRNA and overall survival (OS)	correlation between miRNA profile and overall survival	30 months
Secondary	miRNA in tissue sample	comparison between miRNA expression in serum and in tumoral tissue	30 months