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

N/AWithdrawnNCT02022904

Duke University

Overview

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.

Study Type

INTERVENTIONAL

Allocation

Masking

NONE

Conditions

Prostate Cancer

Interventions

Near infrared (NIR) emissive nanotechnologyDEVICE

Eligibility

Sex: MALEMin age: 18 Years

Medical Language ↔ Plain English

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)

Outcomes

Primary Outcomes

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

Time frame: at baseline, month 3, and progression (up to 18 months)

Secondary Outcomes

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).

Time frame: 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).

Time frame: at baseline, month 3, and progression (up to 18 months)

Correlation of CTC enumeration with presenting clinical stage

Time frame: at baseline, month 3, and progression (up to 18 months)

Correlation of CTC enumeration with sites of metastatic disease

Time frame: at baseline, month 3, and progression (up to 18 months)

Correlation of CTC enumeration with Gleason sum

Time frame: at baseline, month 3, and progression (up to 18 months)

Correlation of CTC enumeration with PSA kinetics

Time frame: at baseline, month 3, and progression (up to 18 months)

Correlation of CTC enumeration with therapies

Time frame: at baseline, month 3, and progression (up to 18 months)

Data from ClinicalTrials.gov

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