Fluciclovine (18F) PET/CT in Predicting Treatment Response in Patients with Recurrent or Metastatic Castration-Resistant Prostate Cancer Receiving Chemotherapy

PRIMARY OBJECTIVES:

I. To determine if uptake on fluciclovine (18F) (anti-3-[18F]FACBC) PET-CT in metastatic lesions with castration resistant prostate carcinoma is affected by chemotherapy.

II. To determine if response on anti-3-[18F]FACBC PET scan after 1 and 6 cycles of chemotherapy (or sooner at end of chemotherapy per patient condition) correlates with clinical and imaging response after these cycles of chemotherapy as measured by standard parameters including prostate specific antigen (PSA) and routine objective measurements.

III. To determine if response on anti-3-[18F]FACBC after 1 and 6 cycles of chemotherapy (or sooner at end of chemotherapy per patient condition) correlates with clinical and imaging response to therapy at one-year as measured by standard parameters including routine objective measurements, PSA progression, clinical progression, and/or mortality.

SECONDARY OBJECTIVES:

I. To determine if uptake on the baseline anti-3-[18F]FACBC PET-CT correlates with response to chemotherapy after 6 cycles and at one year or earlier if progression as measured by standard parameters.

OUTLINE:

Patients receive docetaxel intravenously (IV) on day 1 and prednisone orally (PO) twice daily (BID) every 21 days for 6 courses. Patients receive fluciclovine (18F) IV over 1-2 minutes and then undergo PET/CT at baseline, within 14 days of the completion of course 1 of chemotherapy, and within 14 days of the completion of course 6 of chemotherapy.

After completion of study, patients are followed up for at least 1 year.