Spots Global Cancer Trial Database for CTC, Free DNA, Stem Cells and EMT-related Antigens as Biomarkers of Activity of Cabazitaxel in CRPC.
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Trial Identification
Brief Title: CTC, Free DNA, Stem Cells and EMT-related Antigens as Biomarkers of Activity of Cabazitaxel in CRPC.
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.
Study ID: NCT03381326
Interventions
Study Description
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-resistant prostate cancer.
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 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.
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: MALE
Healthy Volunteers: No
Locations
Ospedali Riuniti Umberto I, Ancona, AN, Italy
Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori (IRST), Meldola, FC, Italy
IRCCS AOU San martino IST, Genova, GE, Italy
Ospedale Civile degli Infermi, Rimini, RN, Italy
Azienda Ospedaliera Cannizzaro, Catania, , Italy
Ospedale Maggiore della Carità, Novara, , Italy
Istituto Oncologico del Veneto (IOV) - Università di Padova, Padova, , Italy
Policlinico Universitario Campus Bio-Medico, Roma, , Italy
Ospedale Sacro Cuore Don Calabria (Negrar), Verona, , Italy
Contact Details
Name: Ugo De Giorgi
Affiliation: Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori (IRST)
Role: PRINCIPAL_INVESTIGATOR
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