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Protocol No. UW15052

Principal Investigator Liu, Glenn

Phase N/A

Age Group Adult

Scope Local

Sponsor Type Institutional

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

Objective The purpose of this research study is to evaluate a newer imaging technique, called 18FSodium Fluoride (NaF) positron emission tomography (PET). 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 cancer that has spread to the bone could be greatly improved. It can be difficult to tell if prostate cancer is responding (shrinking) to treatment. Using NaF PET/CT to look for changes in bone cancer might be a better way to tell if the cancer is responding. We also need to learn more about why some cancer that has spread to the bone responds to treatment and some do not, so this study will also use cancer tissue taken from the bone to look for differences in the cancer cells. Biopsies of a responding (shrinking) and non-responding (not shrinking) cancer that has spread to your bones identified by the NaF PET/CT will be performed after standard treatment with enzalutamide. This will allow evaluation of how the NaF PET scans change with the enzalutamide treatment and whether the scans can be effective tools to direct biopsies.

Treatment NaF PET/CT scans are a special kind of scan done to see what changes happen to your tumor and/or bone. A PET/CT scanner is a special type of camera that can take pictures of the inside of your body. It works by sensing the radioactive tracer (dye) that is injected into you. The tracer, 18F-Sodium Fluoride (NaF), used in this study is also available for clinical use. It is hoped that PET/CT using NaF will create a clearer picture of cancer. Before the scan, up to 5 mCi of the tracer NaF will be administered as an injection. During this time, you may be asked to lie in the scanner twice, the first time about 1 hour after the injection of the tracer and the second time 2 hours after you have received the injection. The total amount of time for each visit can be up to

Description Fourteen days prior to starting enzalutamide, you will have a NaF PET/CT scan. The second study visit will include a 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. At the third and final study visit you will then have a biopsy of both a responding and non-responding prostate cancer area in your bone identified by the NaF PET/CT. If you have already started treatment with enzalutamide prior to consenting for this study and had a NaF PET/CT within 14 days prior to starting your enzalutamide, your first visit will occur after you have taken enzalutamide for 12 weeks and will include a NaF PET/CT. The NaF PET/CT obtained at week 12 will be compared to your first NaF PET/CT. You will have a biopsy of both a responding and non-responding prostate cancer area in your bone as identified by the NaF PET/CTs.

Key Eligibility
  • Histologically proven adenocarcinoma of the prostate
  • Identifiable prostate cancer-related osseous metastases on bone scan or NaF PET/CT in the vertebral body, pelvis or other bone
  • Patients must be starting or have started enzalutamide for treatment of metastatic castrate-resistant prostate within 14 days after undergoing a NaF PET/CT scan evaluation
  • Patients who have already begun treatment with enzalutamide must have started < 12 weeks prior to enrollment and must have completed required screening procedures (other than signing consent) within 28 days of their enzalutamide initiation
  • Patients who have known bleeding diathesis or on therapeutic anticoagulants (warfarin, low-molecular heparin, heparin analogues) that would increase risk of complications from bone biopsies are ineligible
  • Men must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry and for the duration of study participation

Applicable Disease Sites Prostate

Therapies Involved Hormone Therapy

Drugs Involved Not Applicable

Status Open

Participating Institutions UW Hospital and Clinics