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Completed

NCT Number: NCT04662996

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

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.

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Key information

Conditions

Prostate Cancer Disease Attributes Disease Resistance Genital Diseases Genital Diseases, Male Genital Neoplasms, Male Male Urogenital Diseases MicroRNAs Neoplasms Neoplasms by Site Pathologic Processes Pathological Conditions, Signs and Symptoms Prostatic Diseases Prostatic Neoplasms Resistance, Disease Urogenital Diseases Urogenital Neoplasms

Age range

18 year and older

Sex eligibility

Male

Study type

Interventional

Phase

Not applicable

Primary location

University Hospital of Tours

Tours, 37044, France

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Blood sample

Biological

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

Primary outcomes

  1. miRNA and chemotherapy

    Time frame: 30 months

    miRNA expression profile predicting resistance to chemotherapy

  2. miRNA and novel hormonal agent (NHA)

    Time frame: 30 months

    miRNA expression profile predicting resistance to novel hormonal agents

Secondary outcomes

  1. miRNA and progression free survival (PFS)

    Time frame: 30 months

    correlation between miRNA profile and progression free survival

  2. miRNA and overall survival (OS)

    Time frame: 30 months

    correlation between miRNA profile and overall survival

  3. miRNA in tissue sample

    Time frame: 30 months

    comparison between miRNA expression in serum and in tumoral tissue

Sponsors and collaborators

Lead sponsor

University Hospital, Tours

Other

Registry information

Acronym: MiR_CPMRC

Important dates

Study start
2021
Primary completion
2022
Study completion
2023
First posted
Dec 10, 2020
Registry last updated
Feb 12, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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