Isolation of Circulating Tumor Cells Using a Novel EMT-Based Capture Method

NCT02025413 | Completed

• 1 other identifier: Pro00032772
• Study Type: interventional
• Target: 46
• Locations: 1 country
• Sites: 1

Brief Summary

The primary objective of the preliminary lead-in study is to determine whether circulating tumor cells in patients with metastatic progressive castration-resistant prostate cancer or metastatic progressive breast cancer can be captured using a novel mesenchymal-marker based ferrofluid (N-cadherin or O-cadherin based). The primary objective of each comparative cohort (second stage, prostate cancer) is to compare the non-detection rate of circulating tumor cells between the standard and novel methods.

Conditions

Metastatic Progressive Castration-resistant Prostate Cancer; Metastatic Progressive Breast Cancer

Outcome Measures

Primary Outcomes (1)

• Feasibility as measured by successfully detecting at least one CTC in at least 2 out of 10 subjects, comparing the non-detection rate over time.

  The change in non-detection rate will be measured by comparing samples from Screening, Cycle 3, and Progression (up to 3 years)

Secondary Outcomes (4)

• Comparison of the proportion of patients with no detectable CTCs between capture methods over time

  Change will be measured by comparing samples at Screening, Cycle 3, Progression (up to 3 years)

• Changes in CTCs (using each method) over time during systemic therapy

  Screening, Cycle 3, Progression (up to 3 years)

• Change in correlation of CTC enumeration using each method with baseline clinical and pathologic disease characteristics (for example, clinical stage, site of metastatic disease, Gleason sum for CRPC, PSA for CRPC, previous therapies)

  Screening, Cycle 3, Progression (up to 3 years)

• Median number of CTCs detected by each method over time

  Changes will be measured from screening, cycle 3 and progression (up to 3 years)

Study Arms (2)

Metastatic progressive castration-resistant prostate cancer

OTHER

Mesenchymal-marker based ferrofluid (N-cadherin or O-cadherin based)

Device: Mesenchymal-marker based ferrofluid (N-cadherin or O-cadherin based)

Metastatic progressive breast cancer

OTHER

Mesenchymal-marker based ferrofluid (N-cadherin or O-cadherin based)

Device: Mesenchymal-marker based ferrofluid (N-cadherin or O-cadherin based)

Interventions

Mesenchymal-marker based ferrofluid (N-cadherin or O-cadherin based) DEVICE

Metastatic progressive breast cancer; Metastatic progressive castration-resistant prostate cancer

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Histologically confirmed diagnosis of adenocarcinoma of the prostate. Small cell or neuroendocrine tumors of the prostate are also permitted.
• Clinical or radiographic evidence of metastatic disease.
• Castrate levels of testosterone (\<50 ng/dl)
• Evidence of disease progression on or following most recent therapy as evidenced clinically by the treating physician or by either of the following:
• 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 growth of soft tissue/visceral metastases \>1 cm in diameter (2 cm for lymph nodes).
• Age \> 18 years.
• Ability to understand and the willingness to sign a written informed consent document.
• Histologically confirmed diagnosis of invasive breast cancer.
• Clinical or radiographic evidence of metastatic disease.
• Evidence of disease progression on the current or following the most recent therapy, determined either clinically by the treating physician or by radiographic evidence as defined by new bone scan lesions or soft tissue/visceral metastases \>1 cm in diameter (2 cm for lymph nodes).
• Age \> 18 years.
• Ability to understand and the willingness to sign a written informed consent document.

You may not qualify if:

• 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).
• Treatment with an anthracycline or mitoxantrone within 1 week of CTC collection

Sponsors & Collaborators

• Duke University: lead
• Prostate Cancer Foundation: collaborator
• United States Department of Defense: collaborator
• Janssen Diagnostics, LLC: collaborator

Study Sites (1)

Duke University Medical Center

Durham, North Carolina, 27710, United States

Location

Study Officials

• Andrew J Armstrong, MD

  Duke University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: DEVICE FEASIBILITY
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 19, 2013
• First Posted: January 1, 2014
• Study Start: November 1, 2011
• Primary Completion: December 1, 2015
• Study Completion: December 1, 2015
• Last Updated: December 20, 2018

Record last verified: 2018-12

Locations

US (1)