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Clinical Trial Details — Status: Active, not recruiting

Administrative data

NCT number NCT03381326
Other study ID # IRSTB030
Secondary ID
Status Active, not recruiting
Phase
First received
Last updated
Start date December 15, 2014
Est. completion date December 2023

Study information

Verified date May 2023
Source Istituto Scientifico Romagnolo per lo Studio e la cura dei Tumori
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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-resistant prostate cancer.


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 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.


Recruitment information / eligibility

Status Active, not recruiting
Enrollment 104
Est. completion date December 2023
Est. primary completion date October 2019
Accepts healthy volunteers No
Gender Male
Age group 18 Years and older
Eligibility Inclusion Criteria: 1. Ability to understand and the willingness to sign a written informed consent document 2. 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 3. Patients must have metastatic and/or inoperable disease 4. Patients must have received prior therapy docetaxel based and must be candidate to cabazitaxel 5. Life expectancy of greater than 3 months 6. Eastern Cooperative Oncology Group (ECOG) performance status <2 Exclusion Criteria: 1. Participants who are unable to provide informed consent 2. Participation in another clinical trial

Study Design


Intervention

Procedure:
blood and FFPE sample collection
blood sample and Formalin-fixed paraffin-embedded (FFPE) sample collection

Locations

Country Name City State
Italy Ospedali Riuniti Umberto I Ancona AN
Italy Azienda Ospedaliera Cannizzaro Catania
Italy IRCCS AOU San martino IST Genova GE
Italy Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori (IRST) Meldola FC
Italy Ospedale Maggiore della Carità Novara
Italy Istituto Oncologico del Veneto (IOV) - Università di Padova Padova
Italy Ospedale Civile degli Infermi Rimini RN
Italy Policlinico Universitario Campus Bio-Medico Roma
Italy Ospedale Sacro Cuore Don Calabria (Negrar) Verona

Sponsors (1)

Lead Sponsor Collaborator
Istituto Scientifico Romagnolo per lo Studio e la cura dei Tumori

Country where clinical trial is conducted

Italy, 

Outcome

Type Measure Description Time frame Safety issue
Primary Progression free survival (PFS) time between the start of cabazitaxel and the ?rst date of progression as measured by PCWG-2 criteria. 36 months
Secondary Overall survival (OS) The overall survival will be calculated from date of the start of cabazitaxel to death 36 months
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