CTC, Free DNA, Stem Cells and EMT-related Antigens as Biomarkers of Activity of Cabazitaxel in CRPC.
NCT ID: NCT03381326
Last Updated: 2023-06-02
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
104 participants
OBSERVATIONAL
2014-12-15
2023-12-31
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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CASE_ONLY
PROSPECTIVE
Interventions
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blood and FFPE sample collection
blood sample and Formalin-fixed paraffin-embedded (FFPE) sample collection
Eligibility Criteria
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Inclusion Criteria
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
2. Participation in another clinical trial
18 Years
MALE
No
Sponsors
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Istituto Romagnolo per lo Studio dei Tumori Dino Amadori IRST S.r.l. IRCCS
OTHER
Responsible Party
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Principal Investigators
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Ugo De Giorgi
Role: PRINCIPAL_INVESTIGATOR
Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori (IRST)
Locations
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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
Padua, , Italy
Policlinico Universitario Campus Bio-Medico
Roma, , Italy
Ospedale Sacro Cuore Don Calabria (Negrar)
Verona, , Italy
Countries
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References
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Gurioli G, Conteduca V, Brighi N, Scarpi E, Basso U, Fornarini G, Mosca A, Nicodemo M, Banna GL, Lolli C, Schepisi G, Ravaglia G, Bondi I, Ulivi P, De Giorgi U. Circulating tumor cell gene expression and plasma AR gene copy number as biomarkers for castration-resistant prostate cancer patients treated with cabazitaxel. BMC Med. 2022 Jan 31;20(1):48. doi: 10.1186/s12916-022-02244-0.
Conteduca V, Wetterskog D, Castro E, Scarpi E, Romero-Laorden N, Gurioli G, Jayaram A, Lolli C, Schepisi G, Wingate A, Casadei C, Lozano R, Brighi N, Aragon IM, Marin-Aguilera M, Gonzalez-Billalabeitia E, Mellado B, Olmos D, Attard G, De Giorgi U. Plasma androgen receptor and response to adapted and standard docetaxel regimen in castration-resistant prostate cancer: A multicenter biomarker study. Eur J Cancer. 2021 Jul;152:49-59. doi: 10.1016/j.ejca.2021.04.025. Epub 2021 May 30.
Other Identifiers
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IRSTB030
Identifier Type: -
Identifier Source: org_study_id
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