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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 : April 21, 2020
Sponsor:
Information provided by (Responsible Party):
Istituto Scientifico Romagnolo per lo Studio e la cura dei Tumori

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.

Condition or disease Intervention/treatment
Prostate Cancer Metastatic Cancer Castration-resistant Prostate Cancer Circulating Tumor Cells Procedure: blood and FFPE sample collection

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.

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Study Type : Observational
Actual Enrollment : 94 participants
Observational Model: Case-Only
Time Perspective: Prospective
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
Actual Primary Completion Date : October 2019
Estimated Study Completion Date : October 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Prostate Cancer


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


Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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
blood samples and FFPE samples


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Patients with castration-resistant prostate cancer
Criteria

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

Information from the National Library of Medicine

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


Locations
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Italy
Ospedali Riuniti Umberto I
Ancona, AN, Italy
Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori (IRST)
Meldola, FC, Italy, 47014
IRCCS AOU San martino IST
Genova, GE, Italy, 16132
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
Sponsors and Collaborators
Istituto Scientifico Romagnolo per lo Studio e la cura dei Tumori
Investigators
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Principal Investigator: Ugo De Giorgi Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori (IRST)
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Responsible Party: Istituto Scientifico Romagnolo per lo Studio e la cura dei Tumori
ClinicalTrials.gov Identifier: NCT03381326    
Other Study ID Numbers: IRSTB030
First Posted: December 22, 2017    Key Record Dates
Last Update Posted: April 21, 2020
Last Verified: April 2020

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Istituto Scientifico Romagnolo per lo Studio e la cura dei Tumori:
circulating tumor cells
Castration-resistant Prostate Cancer
cabazitaxel
biomarker
free DNA
stem cells
EMT related antigens
Additional relevant MeSH terms:
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Prostatic Neoplasms
Neoplastic Cells, Circulating
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Genital Diseases, Male
Prostatic Diseases
Neoplasm Metastasis
Neoplastic Processes
Pathologic Processes