Clinical trial NCT02022904: Prostate Cancer Circulating Tumor Cells Based on Epithelial-Mesenchymal Transition Biology
Official title: Development of a Novel Method to Detect Prostate Cancer Circulating Tumor Cells (CTCs) Based on Epithelial-mesenchymal Transition Biology
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Prostate Cancer
Keywords: prostate cancer
metastatic
castrate resistant
Lead sponsor: Duke University
Sponsor class: OTHER
Collaborators: name: United States Department of Defense
First posted: 2013-12-30
Enrollment: 0
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP

Brief 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 EpCAM-based NIR-EP. If successful, the capture method will be evaluated further in the larger comparative study.


Eligibility criteria: Inclusion Criteria:

* 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:

  1. Two consecutive PSA levels greater than the PSA nadir achieved on ADT, separated by greater than one week
  2. Radiographic evidence of disease progression as defined by new bone scan lesions or soft tissue/visceral metastases \>2 cm in diameter.
  3. 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

Exclusion Criteria:

* 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)

Primary outcomes:
measure: Change in Non-detection rate of CTC's in men with CRPC
timeFrame: at baseline, month 3, and progression (up to 18 months)
Secondary outcomes:
measure: Median number of CTC's detected by each capture method
timeFrame: baseline, month 3, and progression (up to 18 months)
measure: Change in median number of CTC's for each method
timeFrame: at baseline, month 3, and progression (up to 18 months)
measure: Correlation of CTC enumeration with presenting clinical stage
timeFrame: at baseline, month 3, and progression (up to 18 months)
measure: Correlation of CTC enumeration with sites of metastatic disease
timeFrame: at baseline, month 3, and progression (up to 18 months)
measure: Correlation of CTC enumeration with Gleason sum
timeFrame: at baseline, month 3, and progression (up to 18 months)
measure: Correlation of CTC enumeration with PSA kinetics
timeFrame: at baseline, month 3, and progression (up to 18 months)
measure: Correlation of CTC enumeration with therapies
timeFrame: at baseline, month 3, and progression (up to 18 months)
measure: Correlation of CTC enumeration with overall survival
timeFrame: at baseline, month 3, and progression (up to 18 months)
measure: Correlation of CTC enumeration with progression-free survival
timeFrame: at baseline, month 3, and progression (up to 18 months)
measure: Correlation of CTC enumeration with response to therapy
timeFrame: at baseline, month 3, and progression (up to 18 months)
Other outcomes:
Locations:
Study officials:
affiliation: Duke University
name: Andrew Armstrong, MD
role: PRINCIPAL_INVESTIGATOR
References: