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

Duke University0 sitesMay 2012

ConditionsProstate Cancer

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Prostate Cancer
Sponsor: Duke University
Primary Endpoint: Change in Non-detection rate of CTC's in men with CRPC
Status: Withdrawn
Last Updated: 10 years ago

Overview Investigators Eligibility Criteria Outcomes Similar Trials

Overview

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.

Registry

clinicaltrials.gov

Start Date

May 2012

End Date

June 2015

Last Updated

10 years ago

Study Type

Interventional

Study Design

Single Group

Sex

Male

Investigators

Sponsor

Duke University

Responsible Party

Sponsor

Eligibility Criteria

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)

Outcomes

Primary Outcomes

Change in Non-detection rate of CTC's in men with CRPC

Time Frame: 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 Outcomes

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))
Median number of CTC's detected by each capture method(baseline, month 3, and progression (up to 18 months))
Change in median number of CTC's for each method(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 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))