Prostate Cancer
Conditions
Keywords
prostate cancer, metastatic, castrate resistant
Brief summary
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.
Interventions
DEVICENear infrared (NIR) emissive nanotechnology
Sponsors
United States Department of Defense
Duke University
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Masking
NONE
Eligibility
Sex/Gender
MALE
Age
18 Years to No maximum
Healthy volunteers
No
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: 1. Two consecutive PSA levels greater than the PSA nadir achieved on ADT, separated by greater than one week 2. Radiographic evidence of disease progression as defined by new bone scan lesions or soft tissue/visceral metastases \>2 cm in diameter. 3. Clinical progression as determined by the treating physician. * Age greater than 18 years. * Ability to understand and the willingness to sign a written informed consent document
Exclusion criteria
* 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)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Non-detection rate of CTC's in men with CRPC | at baseline, month 3, and progression (up to 18 months) | Non-detection rate of CTC's in men with CRPC will be measured at baseline, month 3, and at progression |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Correlation of CTC enumeration with therapies | at baseline, month 3, and progression (up to 18 months) | — |
| Median number of CTC's detected by each capture method | baseline, month 3, and progression (up to 18 months) | Calculate for each patient the number of CTC's detected by each capture method (novel and standard). |
| Change in median number of CTC's for each method | at baseline, month 3, and progression (up to 18 months) | 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). |
| Correlation of CTC enumeration with presenting clinical stage | 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 Gleason sum | 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) | — |
| Correlation of CTC enumeration with sites of metastatic disease | at baseline, month 3, and progression (up to 18 months) | — |
Outcome results
None listed