NCT02677376

Imaging Biomarkers to Validate Response in Enzalutamide-Treated mCRPC

Validation of Imaging-Based Biomarkers of Treatment Response in Patients With Metastatic Castration-Resistant Prostate Cancer Treated With Enzalutamide

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 7 (actual)
• Sponsor: University of Wisconsin, Madison · Academic / Other
• Sex: Male
• Age: 18 Years
• Healthy volunteers: Not accepted

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

Type	Name	Description
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).

Timeline

• Start date: 2016-06-27
• Primary completion: 2018-03-30
• Completion: 2020-01-03
• First posted: 2016-02-09
• Last updated: 2020-02-26

Locations

1 site across 1 country: United States