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

Metastatic Progressive Castration-resistant Prostate Cancer Clinical Trial

— CTC-EMT  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02025413
• Other study ID #: Pro00032772
• Status: Completed
• Phase: N/A
• Start date: November 2011
• Est. completion date: December 2015

Study information

• Verified date: December 2018
• Source: Duke University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 46
• Est. completion date: December 2015
• Est. primary completion date: December 2015
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Metastatic Progressive Breast Cancer
• Metastatic Progressive Castration-resistant Prostate Cancer
• Neoplastic Cells, Circulating
• Prostatic Neoplasms

Intervention

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

Locations

Country	Name	City	State
United States	Duke University Medical Center	Durham	North Carolina

Sponsors (4)

Lead Sponsor	Collaborator
Duke University	Janssen Diagnostics, LLC, Prostate Cancer Foundation, United States Department of Defense

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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)
Secondary	Changes in CTCs (using each method) over time during systemic therapy		Screening, Cycle 3, Progression (up to 3 years)
Secondary	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)
Secondary	Median number of CTCs detected by each method over time		Changes will be measured from screening, cycle 3 and progression (up to 3 years)