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

Prostate Cancer Clinical Trial

— IRSTB030  

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.

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT03381326
• Other study ID #: IRSTB030
• Status: Active, not recruiting
• 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
• 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

Related Conditions & MeSH terms

• Castration-resistant Prostate Cancer
• Circulating Tumor Cells
• Metastatic Cancer
• Neoplastic Cells, Circulating
• Prostate Cancer
• Prostatic Neoplasms

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