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

This study has been withdrawn prior to enrollment.
Sponsor:
ClinicalTrials.gov Identifier:
NCT02022904
First Posted: December 30, 2013
Last Update Posted: July 30, 2015
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
United States Department of Defense
Information provided by (Responsible Party):
Duke University
  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: None (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) ]
    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) ]
    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) ]
    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) ]
  • 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) ]
  • Correlation of CTC enumeration with overall survival [ Time Frame: at baseline, month 3, and progression (up to 18 months) ]
  • Correlation of CTC enumeration with progression-free survival [ Time Frame: at baseline, month 3, and progression (up to 18 months) ]
  • Correlation of CTC enumeration with response to therapy [ Time Frame: at baseline, month 3, and progression (up to 18 months) ]

Enrollment: 0
Study Start Date: May 2012
Study Completion Date: June 2015
Primary Completion Date: June 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

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes 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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02022904


Sponsors and Collaborators
Duke University
United States Department of Defense
Investigators
Principal Investigator: Andrew Armstrong, MD Duke University
  More Information

Responsible Party: Duke University
ClinicalTrials.gov Identifier: NCT02022904     History of Changes
Other Study ID Numbers: Pro00037349
First Submitted: December 18, 2013
First Posted: December 30, 2013
Last Update Posted: July 30, 2015
Last Verified: July 2015

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