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

NCT02022904 | Withdrawn

• 1 other identifier: Pro00037349
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Prostate Cancer

Keywords

prostate cancer; metastatic; castrate resistant

Outcome Measures

Primary Outcomes (1)

• 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

  at baseline, month 3, and progression (up to 18 months)

Secondary Outcomes (10)

• Median number of CTC's detected by each capture method

  baseline, month 3, and progression (up to 18 months)

• Change in median number of CTC's for each method

  at baseline, month 3, and progression (up to 18 months)

• 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)

Study Arms (1)

Metastatic prostate cancer

EXPERIMENTAL

Near infrared (NIR) emissive nanotechnology

Device: Near infrared (NIR) emissive nanotechnology

Interventions

Near infrared (NIR) emissive nanotechnology DEVICE

Metastatic prostate cancer

Eligibility Criteria

• Age: 18 Years+
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Duke University: lead
• United States Department of Defense: collaborator

MeSH Terms

Conditions

Prostatic Neoplasms; Neoplasm Metastasis

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases; Neoplastic Processes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Andrew Armstrong, MD

  Duke University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 18, 2013
• First Posted: December 30, 2013
• Study Start: May 1, 2012
• Primary Completion: June 1, 2015
• Study Completion: June 1, 2015
• Last Updated: July 30, 2015

Record last verified: 2015-07