CTC, Free DNA, Stem Cells and EMT-related Antigens as Biomarkers of Activity of Cabazitaxel in CRPC. (IRSTB030)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT03381326|
Recruitment Status : Active, not recruiting
First Posted : December 22, 2017
Last Update Posted : February 27, 2019
|Condition or disease||Intervention/treatment|
|Prostate Cancer Metastatic Cancer Castration-resistant Prostate Cancer Circulating Tumor Cells||Procedure: blood and FFPE sample collection|
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 role of response of the copy number of androgen receptor (AR) and Phosphatase and tensin homolog (PTEN) and AR-V7 and other gene expression biomarkers in CTC and the investigators will compare these results with those obtained in plasma cell free DNA and RNA.
Eligible patients must have histologically or cytologically confirmed prostate cancer or unequivocal increased PSA . Metastatic and/or inoperable disease and received prior therapy with docetaxel and candidate to cabazitaxel treatment.
All patients receive cabazitaxel at standard schedule 25 mg/m2 q21. Blood sample will be collected for CTC evaluation at baseline, after the first cycle of therapy (optional), at first radiological evaluation (after 3 months), at disease progression (optional) or after 9-12 months of treatment for patients who did not show disease progression (optional). Disease progression defined according to Prostate Cancer Working Group 2 (PCWG2) criteria. On blood samples from Castration-Resistant Prostate Cancer (CRPC) patients the investigators will investigate the presence of the previously presented CTC, DNA and RNA free markers.
As an option, it will be possible to require a sample of the tumor collected during prostate surgery or during the biopsy.
All patients will be treated and monitored according to the local clinical practice. No additional procedures/patient visits in comparison with the usual clinical practice are planned for the study.
|Study Type :||Observational|
|Actual Enrollment :||94 participants|
|Official Title:||Biomarkers Study: Circulating Tumor Cells (CTC), Free DNA, Stem Cells and Epithelial-mesenchymal-transition (EMT) Related Antigens as Biomarkers of Activity of Cabazitaxel in Castration-resistant Prostate Cancer (CRPC): a Proof of Concept.|
|Actual Study Start Date :||December 15, 2014|
|Estimated Primary Completion Date :||October 2019|
|Estimated Study Completion Date :||October 2020|
- Procedure: blood and FFPE sample collection
blood sample and Formalin-fixed paraffin-embedded (FFPE) sample collection
- Progression free survival (PFS) [ Time Frame: 36 months ]time between the start of cabazitaxel and the ﬁrst date of progression as measured by PCWG-2 criteria.
- Overall survival (OS) [ Time Frame: 36 months ]The overall survival will be calculated from date of the start of cabazitaxel to death
Biospecimen Retention: Samples With DNA
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03381326
|Ospedali Riuniti Umberto I|
|Ancona, AN, Italy|
|Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori (IRST)|
|Meldola, FC, Italy, 47014|
|Ospedale Civile degli Infermi|
|Rimini, RN, Italy|
|Azienda Ospedaliera Cannizzaro|
|Ospedale Maggiore della Carità|
|Istituto Oncologico del Veneto (IOV) - Università di Padova|
|Policlinico Universitario Campus Bio-Medico|
|Ospedale Sacro Cuore Don Calabria (Negrar)|
|Principal Investigator:||Ugo De Giorgi||Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori (IRST)|