Prostate CancerNCT02022904
Prostate Cancer Circulating Tumor Cells Based on Epithelial-Mesenchymal Transition Biology
A study testing Near infrared (NIR) emissive nanotechnology in people with Prostate Cancer, run by Duke University.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 18 years and older, men only
- Conditions the study is for
- Prostate Cancer
- What is being tested?
- Near infrared (NIR) emissive nanotechnology
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- May 2012to Jun 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
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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:
- 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 soft tissue/visceral metastases >2 cm in diameter.
- 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
Who cannot join
- 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)
About this study
Official title: Development of a Novel Method to Detect Prostate Cancer Circulating Tumor Cells (CTCs) Based on Epithelial-mesenchymal Transition Biology
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.
- Conditions
- Prostate Cancer
- Being tested
- Near infrared (NIR) emissive nanotechnology
- Keywords
- prostate cancer, metastatic, castrate resistant
- Medical subject headings
- Prostatic Neoplasms, Neoplasm Metastasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Near infrared (NIR) emissive nanotechnologyDevice
| Study group | Role | What they receive |
|---|---|---|
| Metastatic prostate cancer | Experimental | Near infrared (NIR) emissive nanotechnology Receives: Device: Near infrared (NIR) emissive nanotechnology |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Non-detection rate of CTC's in men with CRPC
Non-detection rate of CTC's in men with CRPC will be measured at baseline, month 3, and at progression
Measured: at baseline, month 3, and progression (up to 18 months)
Secondary outcomes (10)
Median number of CTC's detected by each capture method
Calculate for each patient the number of CTC's detected by each capture method (novel and standard).
Measured: baseline, month 3, and progression (up to 18 months)
Change in median number of CTC's for each method
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).
Measured: at baseline, month 3, and progression (up to 18 months)
Correlation of CTC enumeration with presenting clinical stage
Measured: at baseline, month 3, and progression (up to 18 months)
Correlation of CTC enumeration with sites of metastatic disease
Measured: at baseline, month 3, and progression (up to 18 months)
Correlation of CTC enumeration with Gleason sum
Measured: at baseline, month 3, and progression (up to 18 months)
Correlation of CTC enumeration with PSA kinetics
Measured: at baseline, month 3, and progression (up to 18 months)
Correlation of CTC enumeration with therapies
Measured: at baseline, month 3, and progression (up to 18 months)
Correlation of CTC enumeration with overall survival
Measured: at baseline, month 3, and progression (up to 18 months)
Correlation of CTC enumeration with progression-free survival
Measured: at baseline, month 3, and progression (up to 18 months)
Correlation of CTC enumeration with response to therapy
Measured: at baseline, month 3, and progression (up to 18 months)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Dec 2013 (estimated)
- Study startMay 2012
- Primary completionJun 2015
- Study completionJun 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for 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
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Duke University
- Sponsor type
- University, hospital or other
- Collaborators
- United States Department of Defense
- Responsible party
- Sponsor
- Investigators
- Andrew Armstrong, MD, Principal investigator, Duke University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02022904
- Sponsor's protocol ID
- Pro00037349
- Status last verified
- Jul 2015
- First submitted
- 18 Dec 2013
- Last updated
- 30 Jul 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Jul 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Development of a Novel Method to Detect Prostate Cancer Circulating Tumor Cells (CTCs) Based on Epithelial-mesenchymal Transition Biology
- ClinicalTrials.gov ID
- NCT02022904
- Acronym / sponsor ID
- Pro00037349
- Conditions
- Prostate Cancer
- Keywords
- prostate cancer, metastatic, castrate resistant
- Study type
- Interventional
- Recruitment status
- Withdrawn
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Duke UniversityUniversity, hospital or other
- Collaborators
- United States Department of Defense
- Study start
- May 2012
- Primary completion
- Jun 2015 (actual)
- Study completion
- Jun 2015 (actual)
- First posted
- 30 Dec 2013 (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.
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.
Study design
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Metastatic prostate cancer | Experimental | Device: Near infrared (NIR) emissive nanotechnologyNear infrared (NIR) emissive nanotechnology |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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:
- Age greater than 18 years.
- Ability to understand and the willingness to sign a written informed consent document
Key exclusion criteria (1 listed)
- 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)
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 |
|---|---|---|
| Near infrared (NIR) emissive nanotechnology | Device | Metastatic prostate cancer |
Primary outcome
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
10 secondary outcomes
Median number of CTC's detected by each capture method
Time frame: baseline, month 3, and progression (up to 18 months)
Change in median number of CTC's for each method
Time frame: at baseline, month 3, and progression (up to 18 months)
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)
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Jul 2015.
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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 Armstrong, MD principal investigator
Duke University
Questions about this trial
What is this clinical trial studying?
A study testing Near infrared (NIR) emissive nanotechnology in people with Prostate Cancer, run by Duke University.
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 8 inclusion and 1 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: withdrawn, as of the sponsor's last update on 30 Jul 2015. Status can change between updates, so confirm with the study contact before making plans.
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 was withdrawn before enrolling participants, so there are no results.
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?
Change in Non-detection rate of CTC's in men with CRPC (time frame: at baseline, month 3, and progression (up to 18 months)). 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 30 Jul 2015.