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| Name | Class |
|---|---|
| Prostate Cancer Foundation | OTHER |
| United States Department of Defense | FED |
| Janssen Diagnostics, LLC | INDUSTRY |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Metastatic progressive castration-resistant prostate cancer | Other | Mesenchymal-marker based ferrofluid (N-cadherin or O-cadherin based) |
|
| Metastatic progressive breast cancer | Other | Mesenchymal-marker based ferrofluid (N-cadherin or O-cadherin based) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Mesenchymal-marker based ferrofluid (N-cadherin or O-cadherin based) | Device |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | The change in non-detection rate will be measured by comparing samples from Screening, Cycle 3, and Progression (up to 3 years) |
| Measure | Description | Time Frame |
|---|---|---|
| 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) | |
| Changes in CTCs (using each method) over time during systemic therapy |
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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:
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:
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| Name | Affiliation | Role |
|---|---|---|
| Andrew J Armstrong, MD | Duke University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Duke University Medical Center | Durham | North Carolina | 27710 | United States |
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| 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) | 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) |