Metastatic Progressive Castration-resistant Prostate CancerCTC-EMTNCT02025413
Isolation of Circulating Tumor Cells Using a Novel EMT-Based Capture Method
A study testing Mesenchymal-marker based ferrofluid (N-cadherin or O-cadherin based) in people with Metastatic Progressive Castration-resistant Prostate Cancer and Metastatic Progressive Breast Cancer, run by Duke University at 1 site in United States.
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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Metastatic Progressive Castration-resistant Prostate Cancer, Metastatic Progressive Breast Cancer
- What is being tested?
- Mesenchymal-marker based ferrofluid (N-cadherin or O-cadherin based)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 46 participants
- Where
- 1 siteUnited States
- Study dates
- Nov 2011to Dec 2015
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Prostate cancer patients will be eligible for inclusion in this study only if all of the following criteria apply:
- 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
Show all 15Show fewer
- 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.
- Breast cancer patients will be eligible for inclusion in this study only if all of the following inclusion criteria apply:
- 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.
Who cannot join
- A patient will not be eligible for inclusion in this study if any of the following criteria apply:
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Duke University Medical Center
Durham, North Carolina, 27710
About this study
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
- Being tested
- Mesenchymal-marker based ferrofluid (N-cadherin or O-cadherin based)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mesenchymal-marker based ferrofluid (N-cadherin or O-cadherin based)Device
| Study group | Role | What they receive |
|---|---|---|
| Metastatic progressive castration-resistant prostate cancer | Other | Mesenchymal-marker based ferrofluid (N-cadherin or O-cadherin based) Receives: 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) Receives: Device: Mesenchymal-marker based ferrofluid (N-cadherin or O-cadherin based) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
Measured: 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
Measured: 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)
Measured: Screening, Cycle 3, Progression (up to 3 years)
Median number of CTCs detected by each method over time
Measured: Changes will be measured from screening, cycle 3 and progression (up to 3 years)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jan 2014 (estimated)
- Study startNov 2011
- Primary completionDec 2015
- Study completionDec 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Metastatic Progressive Castration-resistant Prostate CancerStudies of the same condition, open and under way.
- More trials run by Duke UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Device feasibility
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 46 participants (actual)
Sponsor and investigators
- Lead sponsor
- Duke University
- Sponsor type
- University, hospital or other
- Collaborators
- Prostate Cancer Foundation, United States Department of Defense, Janssen Diagnostics, LLC
- Responsible party
- Sponsor
- Investigators
- Andrew J Armstrong, MD, Principal investigator, Duke University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02025413
- Sponsor's protocol ID
- Pro00032772
- Acronym
- CTC-EMT
- Status last verified
- Dec 2018
- First submitted
- 19 Dec 2013
- Last updated
- 20 Dec 2018
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Dec 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Isolation of Circulating Tumor Cells Using a Novel EMT-Based Capture Method
- ClinicalTrials.gov ID
- NCT02025413
- Acronym / sponsor ID
- CTC-EMT / Pro00032772
- Conditions
- Metastatic Progressive Castration-resistant Prostate Cancer, Metastatic Progressive Breast Cancer
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 46 participants (actual)
- Lead sponsor
- Duke UniversityUniversity, hospital or other
- Collaborators
- Prostate Cancer Foundation, United States Department of Defense, Janssen Diagnostics, LLC
- Study start
- Nov 2011
- Primary completion
- Dec 2015 (actual)
- Study completion
- Dec 2015 (actual)
- First posted
- 1 Jan 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Device feasibility
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Metastatic progressive castration-resistant prostate cancer | Other | Device: Mesenchymal-marker based ferrofluid (N-cadherin or O-cadherin based)Mesenchymal-marker based ferrofluid (N-cadherin or O-cadherin based) |
| Metastatic progressive breast cancer | Other | Device: Mesenchymal-marker based ferrofluid (N-cadherin or O-cadherin based)Mesenchymal-marker based ferrofluid (N-cadherin or O-cadherin based) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (15 listed)
- Prostate cancer patients will be eligible for inclusion in this study only if all of the following criteria apply:
- 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:
Key exclusion criteria (3 listed)
- A patient will not be eligible for inclusion in this study if any of the following criteria apply:
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Mesenchymal-marker based ferrofluid (N-cadherin or O-cadherin based) | Device | Metastatic progressive breast cancer, Metastatic progressive castration-resistant prostate cancer |
Primary outcome
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.
Time frame: The change in non-detection rate will be measured by comparing samples from Screening, Cycle 3, and Progression (up to 3 years)
4 secondary outcomes
Comparison of the proportion of patients with no detectable CTCs between capture methods over time
Time frame: 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
Time frame: 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)
Time frame: Screening, Cycle 3, Progression (up to 3 years)
Median number of CTCs detected by each method over time
Time frame: Changes will be measured from screening, cycle 3 and progression (up to 3 years)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Dec 2018.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Andrew J Armstrong, MD principal investigator
Duke University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Mesenchymal-marker based ferrofluid (N-cadherin or O-cadherin based) in people with Metastatic Progressive Castration-resistant Prostate Cancer and Metastatic Progressive Breast Cancer, run by Duke University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 15 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 Dec 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome 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. (time frame: The change in non-detection rate will be measured by comparing samples from Screening, Cycle 3, and Progression (up to 3 years)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Dec 2018.