Imaging Biomarkers to Validate Response in Enzalutamide-Treated mCRPC

Inclusion Criteria:

- 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. Such lesions must be amenable to serial NaF
PET/CT imaging. Preference will be given to subjects with multiple lesions that can be
imaged in one image acquisition session to obtain maximal information as well as
locations of lesions amenable to bone biopsies.

- Patients must be starting enzalutamide for treatment of metastatic castrate-resistant
prostate, with cycle 1 day 1 occurring within 14 days after the first baseline NaF
PET/CT. Subjects will be allowed to receive enzalutamide treatment on a concurrent
study as long as the enzalutamide treatment study does not prohibit concurrent
participation.

- Men of all races and ethnic groups of age ≥18 years.

- The effects of NaF on the developing human fetus are unknown. For this reason and
because radiopharmaceuticals used for diagnostic imaging and other therapeutic agents
and imaging procedures used in this trial may be or are known to be teratogenic, 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. Should a
woman become pregnant or suspect she is pregnant while her partner is participating in
this study, she should inform her treating physician immediately.

- Patients must be able to comply with all study procedures, including having both the
ability and willingness to lie flat for ≥ 30 minutes during imaging and undergo bone
biopsies.

- Patients must have both the ability to understand and the willingness to sign a
written informed consent document.

Exclusion Criteria:

- Known bleeding diathesis or on therapeutic anticoagulants (warfarin, low-molecular
heparin, heparin analogues) that would increase risk of complications from bone
biopsies.

- History of allergic reactions attributed to compounds of similar chemical or biologic
composition to sodium fluoride F-18 (NaF).