Isolation of Circulating Tumor Cells Using a Novel EMT-Based Capture Method

Duke University1 site in 1 country46 target enrollmentNovember 2011

ConditionsMetastatic Progressive Castration-resistant Prostate Cancer Metastatic Progressive Breast Cancer

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Metastatic Progressive Castration-resistant Prostate Cancer
Sponsor: Duke University
Enrollment: 46
Locations: 1
Primary Endpoint: Feasibility as measured by successfully detecting at least one CTC in at least 2 out of 10 subjects, comparing the non-detection rate over time.
Status: Completed
Last Updated: 7 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

The primary objective of the preliminary lead-in study is to determine whether circulating tumor cells in patients with metastatic progressive castration-resistant prostate cancer or metastatic progressive breast cancer can be captured using a novel mesenchymal-marker based ferrofluid (N-cadherin or O-cadherin based).

The primary objective of each comparative cohort (second stage, prostate cancer) is to compare the non-detection rate of circulating tumor cells between the standard and novel methods.

Registry

clinicaltrials.gov

Start Date

November 2011

End Date

December 2015

Last Updated

7 years ago

Study Type

Interventional

Study Design

Single Group

Sex

All

Investigators

Sponsor

Duke University

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Prostate cancer patients will be eligible for inclusion in this study only if all of the following criteria apply:
•Histologically confirmed diagnosis of adenocarcinoma of the prostate. Small cell or neuroendocrine tumors of the prostate are also permitted.
•Clinical or radiographic evidence of metastatic disease.
•Castrate levels of testosterone (\<50 ng/dl)
•Evidence of disease progression on or following most recent therapy as evidenced clinically by the treating physician or by either of the following:
•Two consecutive PSA levels greater than the PSA nadir achieved on ADT, separated by greater than one week
•Radiographic evidence of disease progression as defined by new bone scan lesions or growth of soft tissue/visceral metastases \>1 cm in diameter (2 cm for lymph nodes).
•Age \> 18 years.
•Ability to understand and the willingness to sign a written informed consent document.
•Breast cancer patients will be eligible for inclusion in this study only if all of the following inclusion criteria apply:

Exclusion Criteria

•A patient will not be eligible for inclusion in this study if any of the following criteria apply:
•History of intercurrent or past medical or psychiatric illness that would make participation in a blood drawing protocol difficult or not feasible at the discretion of the principal investigator or co-investigator(s).
•Treatment with an anthracycline or mitoxantrone within 1 week of CTC collection

Outcomes

Primary Outcomes

Feasibility as measured by successfully detecting at least one CTC in at least 2 out of 10 subjects, comparing the non-detection rate over time.

Time Frame: The change in non-detection rate will be measured by comparing samples from Screening, Cycle 3, and Progression (up to 3 years)

Secondary Outcomes

Changes in CTCs (using each method) over time during systemic therapy(Screening, Cycle 3, Progression (up to 3 years))
Median number of CTCs detected by each method over time(Changes will be measured from screening, cycle 3 and progression (up to 3 years))
Change in correlation of CTC enumeration using each method with baseline clinical and pathologic disease characteristics (for example, clinical stage, site of metastatic disease, Gleason sum for CRPC, PSA for CRPC, previous therapies)(Screening, Cycle 3, Progression (up to 3 years))
Comparison of the proportion of patients with no detectable CTCs between capture methods over time(Change will be measured by comparing samples at Screening, Cycle 3, Progression (up to 3 years))