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

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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

Tracking Information
First Submitted Date December 18, 2017
First Posted Date December 22, 2017
Last Update Posted Date April 21, 2020
Actual Study Start Date December 15, 2014
Actual Primary Completion Date October 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: December 18, 2017)
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.
Original Primary Outcome Measures Same as current
Change History
Current Secondary Outcome Measures
 (submitted: December 18, 2017)
Overall survival (OS) [ Time Frame: 36 months ]
The overall survival will be calculated from date of the start of cabazitaxel to death
Original Secondary Outcome Measures Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
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.
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.

Study Type Observational
Study Design Observational Model: Case-Only
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Retention:   Samples With DNA
Description:
blood samples and FFPE samples
Sampling Method Probability Sample
Study Population Patients with castration-resistant prostate cancer
Condition
  • Prostate Cancer
  • Metastatic Cancer
  • Castration-resistant Prostate Cancer
  • Circulating Tumor Cells
Intervention Procedure: blood and FFPE sample collection
blood sample and Formalin-fixed paraffin-embedded (FFPE) sample collection
Study Groups/Cohorts Not Provided
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Active, not recruiting
Actual Enrollment
 (submitted: February 26, 2019)
94
Original Estimated Enrollment
 (submitted: December 18, 2017)
90
Estimated Study Completion Date October 2020
Actual Primary Completion Date October 2019   (Final data collection date for primary outcome measure)
Eligibility 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
Sex/Gender
Sexes Eligible for Study: Male
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries Italy
Removed Location Countries  
 
Administrative Information
NCT Number NCT03381326
Other Study ID Numbers IRSTB030
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement Not Provided
Responsible Party Istituto Scientifico Romagnolo per lo Studio e la cura dei Tumori
Study Sponsor Istituto Scientifico Romagnolo per lo Studio e la cura dei Tumori
Collaborators Not Provided
Investigators
Principal Investigator: Ugo De Giorgi Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori (IRST)
PRS Account Istituto Scientifico Romagnolo per lo Studio e la cura dei Tumori
Verification Date April 2020