Clinical trial NCT02025413: Isolation of Circulating Tumor Cells Using a Novel EMT-Based Capture Method
Official title: Isolation of Circulating Tumor Cells Using a Novel EMT-Based Capture Method
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Metastatic Progressive Castration-resistant Prostate Cancer
Metastatic Progressive Breast Cancer
Lead sponsor: Duke University
Sponsor class: OTHER
Collaborators: name: Prostate Cancer Foundation
name: United States Department of Defense
name: Janssen Diagnostics, LLC
First posted: 2014-01-01
Enrollment: 46
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: DEVICE_FEASIBILITY

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.


Eligibility criteria: Inclusion Criteria:

Prostate cancer patients will be eligible for inclusion in this study only if all of the following criteria apply:

1. Histologically confirmed diagnosis of adenocarcinoma of the prostate. Small cell or neuroendocrine tumors of the prostate are also permitted.
2. Clinical or radiographic evidence of metastatic disease.
3. Castrate levels of testosterone (\<50 ng/dl)
4. 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).
5. Age \> 18 years.
6. Ability to understand and the willingness to sign a written informed consent document.

Breast cancer patients will be eligible for inclusion in this study only if all of the following inclusion criteria apply:

1. Histologically confirmed diagnosis of invasive breast cancer.
2. Clinical or radiographic evidence of metastatic disease.
3. 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).
4. Age \> 18 years.
5. Ability to understand and the willingness to sign a written informed consent document.

Exclusion Criteria:

A patient will not be eligible for inclusion in this study if any of the following criteria apply:

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

Primary outcomes:
measure: 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.
timeFrame: The change in non-detection rate will be measured by comparing samples from Screening, Cycle 3, and Progression (up to 3 years)
Secondary outcomes:
measure: Comparison of the proportion of patients with no detectable CTCs between capture methods over time
timeFrame: Change will be measured by comparing samples at Screening, Cycle 3, Progression (up to 3 years)
measure: Changes in CTCs (using each method) over time during systemic therapy
timeFrame: Screening, Cycle 3, Progression (up to 3 years)
measure: 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)
timeFrame: Screening, Cycle 3, Progression (up to 3 years)
measure: Median number of CTCs detected by each method over time
timeFrame: Changes will be measured from screening, cycle 3 and progression (up to 3 years)
Other outcomes:
Locations:
city: Durham
country: United States
facility: Duke University Medical Center
state: North Carolina
Study officials:
affiliation: Duke University
name: Andrew J Armstrong, MD
role: PRINCIPAL_INVESTIGATOR
References: