Prostate Cancer Circulating Tumor Cells Based on Epithelial-Mesenchymal Transition Biology

Not Applicable

Withdrawn

• Conditions: Prostate Cancer
• Interventions: Device: Near infrared (NIR) emissive nanotechnology

• Registration Number: NCT02022904
• Lead Sponsor: Duke University

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2012-05
• Study First Submitted: 2013-12-18
• Study First Submitted QC: 2013-12-23
• Study First Posted: 2013-12-30
• Primary Completion: 2015-06
• Study Completion: 2015-06
• Status Verified: 2015-07
• Last Update Submitted: 2015-07-28
• Last Update Posted: 2015-07-30

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: Male
• Target Recruitment: Not specified

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

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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)

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Metastatic prostate cancer	Near infrared (NIR) emissive nanotechnology	Near infrared (NIR) emissive nanotechnology

Primary Outcome Measures

Name	Time	Method
Change in Non-detection rate of CTC's in men with CRPC	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

Secondary Outcome Measures

Name	Time	Method
Correlation of CTC enumeration with PSA kinetics	at baseline, month 3, and progression (up to 18 months)
Correlation of CTC enumeration with therapies	at baseline, month 3, and progression (up to 18 months)
Median number of CTC's detected by each capture method	baseline, month 3, and progression (up to 18 months)	Calculate for each patient the number of CTC's detected by each capture method (novel and standard).
Change in median number of CTC's for each method	at baseline, month 3, and progression (up to 18 months)	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).
Correlation of CTC enumeration with presenting clinical stage	at baseline, month 3, and progression (up to 18 months)
Correlation of CTC enumeration with sites of metastatic disease	at baseline, month 3, and progression (up to 18 months)
Correlation of CTC enumeration with Gleason sum	at baseline, month 3, and progression (up to 18 months)
Correlation of CTC enumeration with overall survival	at baseline, month 3, and progression (up to 18 months)
Correlation of CTC enumeration with progression-free survival	at baseline, month 3, and progression (up to 18 months)
Correlation of CTC enumeration with response to therapy	at baseline, month 3, and progression (up to 18 months)