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.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
DEVICE_FEASIBILITY
Masking
NONE
Enrollment
46
Duke University Medical Center
Durham, North Carolina, United States
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)
Comparison of the proportion of patients with no detectable CTCs between capture methods over time
Time frame: Change will be measured by comparing samples at Screening, Cycle 3, Progression (up to 3 years)
Changes in CTCs (using each method) over time during systemic therapy
Time frame: Screening, Cycle 3, 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)
Time frame: Screening, Cycle 3, Progression (up to 3 years)
Median number of CTCs detected by each method over time
Time frame: Changes will be measured from screening, cycle 3 and progression (up to 3 years)
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