Prostate Cancer Circulating Tumor Cells Based on Epithelial-Mesenchymal Transition Biology

Study Overview
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Brief Summary
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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.

Official Title
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Development of a Novel Method to Detect Prostate Cancer Circulating Tumor Cells (CTCs) Based on Epithelial-mesenchymal Transition Biology

Conditions
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Prostate Cancer

Intervention / Treatment
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* Device: Near infrared (NIR) emissive nanotechnology


Participation Criteria
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Eligibility Criteria
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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: 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 soft tissue/visceral metastases >2 cm in diameter. 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)

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Metastatic prostate cancer<br>Near infrared (NIR) emissive nanotechnology | Device: Near infrared (NIR) emissive nanotechnology<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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) | 

Secondary Outcome Measures

| Outcome Measure | 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 | 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) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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prostate cancer, metastatic, castrate resistant