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

NCT ID: NCT04662996

Last Updated: 2023-11-29

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Clinical Phase

NA

Total Enrollment

33 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-06-23

Study Completion Date

2023-11-30

Brief Summary

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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

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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.

Conditions

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Prostate Cancer Resistance, Disease MicroRNAs

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Intervention: blood sample at inclusion. primary purpose: to better understand resistance mechanisms to prostate cancer treatment.
Primary Study Purpose

OTHER

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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1- Chemotherapy

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

Group Type EXPERIMENTAL

Blood sample

Intervention Type BIOLOGICAL

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

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

Group Type EXPERIMENTAL

Blood sample

Intervention Type BIOLOGICAL

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

Interventions

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Blood sample

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

Intervention Type BIOLOGICAL

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

No

Sponsors

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University Hospital, Tours

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Mathilde CANCEL, MD

Role: STUDY_DIRECTOR

University Hospital, Tours

Locations

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University Hospital of Tours

Tours, , France

Site Status

Countries

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France

References

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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.

Reference Type BACKGROUND
PMID: 25129854 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 29644941 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 24714754 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 29102917 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 31043708 (View on PubMed)

Other Identifiers

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2020-A03304-35

Identifier Type: REGISTRY

Identifier Source: secondary_id

DR200300 _MiR_CPMRC

Identifier Type: -

Identifier Source: org_study_id