Status:

UNKNOWN

CTC, Free DNA, Stem Cells and EMT-related Antigens as Biomarkers of Activity of Cabazitaxel in CRPC.

Lead Sponsor:

Istituto Romagnolo per lo Studio dei Tumori Dino Amadori IRST S.r.l. IRCCS

Conditions:

Prostate Cancer

Metastatic Cancer

Eligibility:

MALE

18+ years

Brief Summary

Identification of biomarkers (Circulating Tumor Cells (CTC), free DNA, Stem Cells and EMT-related antigens) that may be predictive of outcome of activity of cabazitaxel treatment in castration-resista...

Detailed Description

Circulating Tumor Cells, free DNA, Stem Cells and EMT-related antigens as biomarkers of activity of cabazitaxel in castration-resistant prostate cancer Primary objectives: To evaluate the prognostic ...

Eligibility Criteria

Inclusion

  • Ability to understand and the willingness to sign a written informed consent document
  • Male aged \>18 years with metastatic castration-resistant disease with documented clinical (imaging) and/or biochemical progression (PSA increasing values) during or after a previous docetaxel-based chemotherapy
  • Patients must have metastatic and/or inoperable disease
  • Patients must have received prior therapy docetaxel based and must be candidate to cabazitaxel
  • Life expectancy of greater than 3 months
  • Eastern Cooperative Oncology Group (ECOG) performance status \<2

Exclusion

  • Participants who are unable to provide informed consent
  • Participation in another clinical trial

Key Trial Info

Start Date :

December 15 2014

Trial Type :

OBSERVATIONAL

Allocation :

ACTUAL

End Date :

December 1 2023

Estimated Enrollment :

104 Patients enrolled

Trial Details

Trial ID

NCT03381326

Start Date

December 15 2014

End Date

December 1 2023

Last Update

June 2 2023

Active Locations (9)

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Page 1 of 3 (9 locations)

1

Ospedali Riuniti Umberto I

Ancona, AN, Italy

2

Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori (IRST)

Meldola, FC, Italy, 47014

3

IRCCS AOU San martino IST

Genova, GE, Italy, 16132

4

Ospedale Civile degli Infermi

Rimini, RN, Italy