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| Name | Class |
|---|---|
| United States Department of Defense | FED |
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This is a minimal risk correlative clinical blood-drawing protocol. The objective of this lead in pilot component is to determine whether Circulating Tumor Cells (CTC's) can be captured using the novel mesenchymal-marker based Near Infrared-Emissive Polymersomes (NIR-EPs), the PSMA-based NIR-EP, and the epithelial EpCAM-based NIR-EP. If successful, the capture method will be evaluated further in the larger comparative study.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Metastatic prostate cancer | Experimental | Near infrared (NIR) emissive nanotechnology |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Near infrared (NIR) emissive nanotechnology | Device |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change in Non-detection rate of CTC's in men with CRPC | Non-detection rate of CTC's in men with CRPC will be measured at baseline, month 3, and at progression | at baseline, month 3, and progression (up to 18 months) |
| Measure | Description | Time Frame |
|---|---|---|
| Median number of CTC's detected by each capture method | Calculate for each patient the number of CTC's detected by each capture method (novel and standard). | baseline, month 3, and progression (up to 18 months) |
| Change in median number of CTC's for each method |
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Inclusion Criteria:
histologically confirmed diagnosis of adenocarcinoma of the prostate
Clinical or radiographic evidence of metastatic disease
Evidence of disease progression on androgen deprivation therapy (ADT) as evidenced by either of the following in the past:
Age greater than 18 years.
Ability to understand and the willingness to sign a written informed consent document
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Andrew Armstrong, MD | Duke University | Principal Investigator |
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| ID | Term |
|---|---|
| D011471 | Prostatic Neoplasms |
| D009362 | Neoplasm Metastasis |
| ID | Term |
|---|---|
| D005834 | Genital Neoplasms, Male |
| D014565 | Urogenital Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
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For each method, we will plot the change across time (baseline, cycle 3, and at progression) in the median number of CTC's for each method (novel and standard). |
| at baseline, month 3, and progression (up to 18 months) |
| Correlation of CTC enumeration with presenting clinical stage | at baseline, month 3, and progression (up to 18 months) |
| Correlation of CTC enumeration with sites of metastatic disease | at baseline, month 3, and progression (up to 18 months) |
| Correlation of CTC enumeration with Gleason sum | at baseline, month 3, and progression (up to 18 months) |
| Correlation of CTC enumeration with PSA kinetics | at baseline, month 3, and progression (up to 18 months) |
| Correlation of CTC enumeration with therapies | at baseline, month 3, and progression (up to 18 months) |
| Correlation of CTC enumeration with overall survival | at baseline, month 3, and progression (up to 18 months) |
| Correlation of CTC enumeration with progression-free survival | at baseline, month 3, and progression (up to 18 months) |
| Correlation of CTC enumeration with response to therapy | at baseline, month 3, and progression (up to 18 months) |
| D005832 |
| Genital Diseases, Male |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D011469 | Prostatic Diseases |
| D052801 | Male Urogenital Diseases |
| D009385 | Neoplastic Processes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |