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

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

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 Overview

• Status: Withdrawn
• Conditions: Prostate Cancer
• Intervention / Treatment: Device: Near infrared (NIR) emissive nanotechnology

• Study Type: Interventional
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Male

Description

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 Plan

How is the study designed?

Design Details

• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Metastatic prostate cancer; Near infrared (NIR) emissive nanotechnology	Device: Near infrared (NIR) emissive nanotechnology

What is the study measuring?

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)

Collaborators and Investigators

• Sponsor: Duke University
• Collaborators: United States Department of Defense
• Investigators: Principal Investigator: Andrew Armstrong, MD, Duke University

Study record dates

Study Major Dates

• Study Start: May 1, 2012
• Primary Completion (Actual): June 1, 2015
• Study Completion (Actual): June 1, 2015

Study Registration Dates

• First Submitted: December 18, 2013
• First Submitted That Met QC Criteria: December 23, 2013
• First Posted (Estimate): December 30, 2013

Study Record Updates

• Last Update Posted (Estimate): July 30, 2015
• Last Update Submitted That Met QC Criteria: July 28, 2015
• Last Verified: July 1, 2015

More Information

Terms related to this study

• Keywords: prostate cancer; metastatic; castrate resistant
• Additional Relevant MeSH Terms: Pathologic Processes; Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Genital Neoplasms, Male; Prostatic Diseases; Neoplastic Processes; Neoplasm Metastasis; Prostatic Neoplasms; Neoplastic Cells, Circulating
• Other Study ID Numbers: Pro00037349