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CIRCULATING MICRO-RNA (miRNA) AND AR-V7 MUTATIONAL STATUS IN METASTATIC CASTRATION-RESISTANT PROSTATE CANCER (CRPC): PRIMERA+ STUDY (PROSTATE CANCER INNOVATING MARKERS OF EXPECTED RESPONSE TO AGONIST LHRH+ ANDROGEN RECEPTOR INHIBITION

NCT04188275 · Status: UNKNOWN · Type: OBSERVATIONAL · Enrollment: 46

Last updated 2019-12-05

No results posted yet for this study

Summary

Observational prospective study investigating the plasmatic levels of miRNA according to AR-V7 mutational status in mCRPC patients receiving standard of care therapy. At the time of the enrollment, patients will undergo determination of AR-V7 splice variants on circulating tumor cells and periodic assessment of circulating levels of miRNA at different time points during the treatment course (initiation, 8-weeks assessment, progression); irrespectively of AR-V7 status patients will be allocated to endocrine therapy with enzalutamide or abiraterone plus LHRH agonist (decapeptyl every 3 months) according to standard of care. Integration of local treatment (in particular radiotherapy) will be allowed on oligoprogressive sites of disease and its impact on overall outcome and miRNA levels will be assessed.

Conditions

  • D011471
  • D064129
  • D035683
  • D009360
  • D014408

Interventions

DIAGNOSTIC_TEST

Periodic ARV7 and miRNA evaluation

Determination of AR-V7 splice variants on circulating tumor cells and evaluation of circulating levels of miRNA by blood sample collection during PSA assessment at different time points along the treatment course (initiation, 8-weeks assessment, progression).

Sponsors & Collaborators

  • Azienda Ospedaliero-Universitaria Careggi

    lead OTHER

Eligibility

Min Age
18 Years
Sex
MALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-12-01
Primary Completion
2020-06-30
Completion
2022-06-30

Countries

  • Italy

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04188275 on ClinicalTrials.gov