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

This study is currently recruiting participants. (see Contacts and Locations)
Verified June 2014 by Duke University
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Duke University
ClinicalTrials.gov Identifier:
NCT02022904
First received: December 18, 2013
Last updated: June 12, 2014
Last verified: June 2014
  Purpose

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.


Condition Intervention
Prostate Cancer
Device: Near infrared (NIR) emissive nanotechnology

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Open Label
Official Title: Development of a Novel Method to Detect Prostate Cancer Circulating Tumor Cells (CTCs) Based on Epithelial-mesenchymal Transition Biology

Resource links provided by NLM:


Further study details as provided by Duke University:

Primary Outcome Measures:
  • Change in Non-detection rate of CTC's in men with CRPC [ Time Frame: at baseline, month 3, and progression (up to 18 months) ] [ Designated as safety issue: No ]
    Non-detection rate of CTC's in men with CRPC will be measured at baseline, month 3, and at progression


Secondary Outcome Measures:
  • Median number of CTC's detected by each capture method [ Time Frame: baseline, month 3, and progression (up to 18 months) ] [ Designated as safety issue: No ]
    Calculate for each patient the number of CTC's detected by each capture method (novel and standard).

  • Change in median number of CTC's for each method [ Time Frame: at baseline, month 3, and progression (up to 18 months) ] [ Designated as safety issue: No ]
    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).

  • Correlation of CTC enumeration with presenting clinical stage [ Time Frame: at baseline, month 3, and progression (up to 18 months) ] [ Designated as safety issue: No ]
  • Correlation of CTC enumeration with sites of metastatic disease [ Time Frame: at baseline, month 3, and progression (up to 18 months) ] [ Designated as safety issue: No ]
  • Correlation of CTC enumeration with Gleason sum [ Time Frame: at baseline, month 3, and progression (up to 18 months) ] [ Designated as safety issue: No ]
  • Correlation of CTC enumeration with PSA kinetics [ Time Frame: at baseline, month 3, and progression (up to 18 months) ] [ Designated as safety issue: No ]
  • Correlation of CTC enumeration with therapies [ Time Frame: at baseline, month 3, and progression (up to 18 months) ] [ Designated as safety issue: No ]
  • Correlation of CTC enumeration with overall survival [ Time Frame: at baseline, month 3, and progression (up to 18 months) ] [ Designated as safety issue: No ]
  • Correlation of CTC enumeration with progression-free survival [ Time Frame: at baseline, month 3, and progression (up to 18 months) ] [ Designated as safety issue: No ]
  • Correlation of CTC enumeration with response to therapy [ Time Frame: at baseline, month 3, and progression (up to 18 months) ] [ Designated as safety issue: No ]

Estimated Enrollment: 50
Study Start Date: May 2012
Estimated Study Completion Date: December 2016
Estimated Primary Completion Date: December 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Metastatic prostate cancer
Near infrared (NIR) emissive nanotechnology
Device: Near infrared (NIR) emissive nanotechnology

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   No
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:

    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)
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02022904

Contacts
Contact: Alica Wilkerson 919-681-2162 alicia.wilkerson@dm.duke.edu

Locations
United States, North Carolina
Duke University Medical Center Recruiting
Durham, North Carolina, United States, 27710
Contact: Alicia Wilkerson    919-681-2162    alicia.wilkerson@dm.duke.edu   
Principal Investigator: Andrew Armstrong, MD         
Sponsors and Collaborators
Duke University
Investigators
Principal Investigator: Andrew Armstrong, MD Duke University
  More Information

No publications provided

Responsible Party: Duke University
ClinicalTrials.gov Identifier: NCT02022904     History of Changes
Other Study ID Numbers: Pro00037349
Study First Received: December 18, 2013
Last Updated: June 12, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by Duke University:
prostate cancer
metastatic
castrate resistant

Additional relevant MeSH terms:
Prostatic Neoplasms
Neoplastic Cells, Circulating
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Genital Diseases, Male
Prostatic Diseases
Neoplasm Metastasis
Neoplastic Processes
Pathologic Processes

ClinicalTrials.gov processed this record on September 16, 2014