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Imaging Biomarkers to Validate Response in Enzalutamide-Treated mCRPC

NCT02677376 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 7

Last updated 2020-02-26

No results posted yet for this study

Summary

To determine the feasibility and success rate of tumor tissue procurement using molecular-image-directed biopsies of responding and non-responding osseous metastases, measured by NaF PET/CT, in patients with metastatic castrate-resistant prostate cancer.

Conditions

  • Prostatic Neoplasms

Interventions

OTHER

18F-Sodium Fluoride (NaF)

NaF is a tracer (dye) that will show changes to the cancer in bones. By using this tracer with PET/CT imaging, our ability to evaluate and measure changes in bone lesions could be greatly improved. Participants will have a NaF PET/CT scan within 14 days prior to starting enzalutamide. All subjects will undergo a second NaF PET/CT scan after taking enzalutamide for 12 weeks. The NaF PET/CT obtained at week 12 will be compared to the first NaF PET/CT to identify a bone tumor that is responding (shrinking) and a bone tumor that is not responding (not shrinking).

Sponsors & Collaborators

  • Prostate Cancer Foundation

    collaborator OTHER

  • University of Wisconsin, Madison

    lead OTHER

Principal Investigators

  • Glenn Liu · Principal Investigator

Eligibility

Min Age
18 Years
Sex
MALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-06-27
Primary Completion
2018-03-30
Completion
2020-01-03

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02677376 on ClinicalTrials.gov