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

Primary Purpose

Prostate Cancer, Resistance, Disease, MicroRNAs

Status
Recruiting
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Blood sample
Sponsored by
University Hospital, Tours
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Prostate Cancer

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)MaleDoes not accept healthy volunteers

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

Sites / Locations

  • CANCELRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

1- Chemotherapy

2- Novel Hormonal Agent

Arm Description

Intervention : one blood sample is done before beginning chemotherapy as a first treatment line for a metastatic castration resistant prostate cancer

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

Outcomes

Primary Outcome Measures

miRNA and chemotherapy
miRNA expression profile predicting resistance to chemotherapy
miRNA and novel hormonal agent (NHA)
miRNA expression profile predicting resistance to novel hormonal agents

Secondary Outcome Measures

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

Full Information

First Posted
December 3, 2020
Last Updated
May 17, 2022
Sponsor
University Hospital, Tours
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1. Study Identification

Unique Protocol Identification Number
NCT04662996
Brief Title
Search for Predictive Factors of Resistance to Treatment for Metastatic Castration-resistant Prostate Cancer by Studying the Expression of microRNAs
Acronym
MiR_CPMRC
Official Title
Search for Predictive Factors of Resistance to Treatment for Metastatic Castration-resistant Prostate Cancer by Studying the Expression of microRNAs
Study Type
Interventional

2. Study Status

Record Verification Date
May 2022
Overall Recruitment Status
Recruiting
Study Start Date
June 23, 2021 (Actual)
Primary Completion Date
September 1, 2023 (Anticipated)
Study Completion Date
October 1, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital, Tours

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Prostate Cancer, Resistance, Disease, MicroRNAs

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Intervention: blood sample at inclusion. primary purpose: to better understand resistance mechanisms to prostate cancer treatment.
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Non-Randomized
Enrollment
50 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
1- Chemotherapy
Arm Type
Experimental
Arm Description
Intervention : one blood sample is done before beginning chemotherapy as a first treatment line for a metastatic castration resistant prostate cancer
Arm Title
2- Novel Hormonal Agent
Arm Type
Experimental
Arm Description
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
Intervention Type
Biological
Intervention Name(s)
Blood sample
Intervention Description
one blood sample is done before beginning a first treatment line for a metastatic castration resistant prostate cancer
Primary Outcome Measure Information:
Title
miRNA and chemotherapy
Description
miRNA expression profile predicting resistance to chemotherapy
Time Frame
30 months
Title
miRNA and novel hormonal agent (NHA)
Description
miRNA expression profile predicting resistance to novel hormonal agents
Time Frame
30 months
Secondary Outcome Measure Information:
Title
miRNA and progression free survival (PFS)
Description
correlation between miRNA profile and progression free survival
Time Frame
30 months
Title
miRNA and overall survival (OS)
Description
correlation between miRNA profile and overall survival
Time Frame
30 months
Title
miRNA in tissue sample
Description
comparison between miRNA expression in serum and in tumoral tissue
Time Frame
30 months

10. Eligibility

Sex
Male
Gender Based
Yes
Gender Eligibility Description
prostate cancer only concerns male people
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
mathilde cancel, md
Phone
md
Email
m.cancel@chu-tours.fr
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
mathilde cancel, md
Organizational Affiliation
ONCOLOGUE
Official's Role
Principal Investigator
Facility Information:
Facility Name
CANCEL
City
Tours
ZIP/Postal Code
37000
Country
France
Individual Site Status
Recruiting

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
25129854
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.
Results Reference
background
PubMed Identifier
29644941
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.
Results Reference
background
PubMed Identifier
24714754
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.
Results Reference
background
PubMed Identifier
29102917
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.
Results Reference
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PubMed Identifier
31043708
Citation
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.
Results Reference
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Search for Predictive Factors of Resistance to Treatment for Metastatic Castration-resistant Prostate Cancer by Studying the Expression of microRNAs

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