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

Prostate Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT02022904
• Other study ID #: Pro00037349
• Status: Withdrawn
• Phase: N/A
• First received: December 18, 2013
• Last updated: July 28, 2015
• Start date: May 2012
• Est. completion date: June 2015

Study information

• Verified date: July 2015
• Source: Duke University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: June 2015
• Est. primary completion date: June 2015
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years and older

Eligibility

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)

Study Design

Intervention Model: Single Group Assignment, Masking: Open Label

Related Conditions & MeSH terms

• Neoplastic Cells, Circulating
• Prostate Cancer
• Prostatic Neoplasms

Intervention

Device:
• Near infrared (NIR) emissive nanotechnology

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Duke University	United States Department of Defense

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)	No
Secondary	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)	No
Secondary	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)	No
Secondary	Correlation of CTC enumeration with presenting clinical stage		at baseline, month 3, and progression (up to 18 months)	No
Secondary	Correlation of CTC enumeration with sites of metastatic disease		at baseline, month 3, and progression (up to 18 months)	No
Secondary	Correlation of CTC enumeration with Gleason sum		at baseline, month 3, and progression (up to 18 months)	No
Secondary	Correlation of CTC enumeration with PSA kinetics		at baseline, month 3, and progression (up to 18 months)	No
Secondary	Correlation of CTC enumeration with therapies		at baseline, month 3, and progression (up to 18 months)	No
Secondary	Correlation of CTC enumeration with overall survival		at baseline, month 3, and progression (up to 18 months)	No
Secondary	Correlation of CTC enumeration with progression-free survival		at baseline, month 3, and progression (up to 18 months)	No
Secondary	Correlation of CTC enumeration with response to therapy		at baseline, month 3, and progression (up to 18 months)	No