CTC, Free DNA, Stem Cells and EMT-related Antigens as Biomarkers of Activity of Cabazitaxel in CRPC. (IRSTB030)

June 1, 2023 updated by: Istituto Scientifico Romagnolo per lo Studio e la cura dei Tumori

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.

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.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

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.

Study Type

Observational

Enrollment (Actual)

104

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Italy
      • Catania, Italy
        • Azienda Ospedaliera Cannizzaro
      • Novara, Italy
        • Ospedale Maggiore della Carità
      • Padova, Italy
        • Istituto Oncologico del Veneto (IOV) - Università di Padova
      • Roma, Italy
        • Policlinico Universitario Campus Bio-Medico
      • Verona, Italy
        • Ospedale Sacro Cuore Don Calabria (Negrar)
    • AN
      • Ancona, AN, Italy
        • Ospedali Riuniti Umberto I
    • FC
      • Meldola, FC, Italy, 47014
        • Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori (IRST)
    • GE
      • Genova, GE, Italy, 16132
        • IRCCS AOU San martino IST
    • RN
      • Rimini, RN, Italy
        • Ospedale Civile degli Infermi

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Sampling Method

Probability Sample

Study Population

Patients with castration-resistant prostate cancer

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Case-Only
  • Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
36 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Overall survival (OS)
Time Frame: 36 months
The overall survival will be calculated from date of the start of cabazitaxel to death
36 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Istituto Scientifico Romagnolo per lo Studio e la cura dei Tumori

Investigators

  • Principal Investigator: Ugo De Giorgi, Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori (IRST)

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 15, 2014

Primary Completion (Actual)

October 1, 2019

Study Completion (Estimated)

December 1, 2023

Study Registration Dates

First Submitted

December 18, 2017

First Submitted That Met QC Criteria

December 18, 2017

First Posted (Actual)

December 22, 2017

Study Record Updates

Last Update Posted (Estimated)

June 2, 2023

Last Update Submitted That Met QC Criteria

June 1, 2023

Last Verified

May 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IRSTB030

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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