A Phase 2, Multicenter Evaluation of 18F-Fluoride PET as
a Pharmacodynamic Biomarker for Dasatinib, a Src Kinase Inhibitor,
in Men With Castration-Resistant Prostate Cancer
and Bone Metastases (BMS #180-279)
Principal Investigator: Evan Y. Yu, MD
Site Participation Note: This imaging protocol is a companion to the therapeutic
protocol designed by Dr. Phillip G. Febbo of the University of California, San Francisco,
entitled “Genomic Guided Therapy with Dasatinib or Nilutamide in Metastatic Castration-
Resistant Prostate Cancer" and all sites must participate in both protocols.
For information about site participation, contact project manager Donna Hartfeil at
Overview: The companion imaging trial allows eligible patients currently
enrolled in Dr. Febbo’s therapeutic trial and receiving dasatinib to undergo
18F-fluoride PET imaging. Dr. Febbo’s therapeutic trial is supported through
the Department of Defense (DoD) and Bristol-Meyers Squibb (BMS). The
companion imaging protocol is funded by the National Cancer Institute
Main Objective: The main objective of this trial is to determine whether changes
in regional fluoride incorporation, measured by 18F-fluoride PET (SUV and Ki), will
occur in both castration-resistant prostate cancer bone metastases and normal
bone as a response to treatment with dasatinib.
Participants: Men with bone-metastatic castration-resistant prostate cancer
(serum testosterone < 50 ng/dL) who are participating on a separate therapeutic
clinical trial (Febbo et al.) and receiving dasatinib as therapy are eligible for this
companion 18F-fluoride PET imaging protocol. Participants from the Febbo trial
receiving nilutamide only will not undergo 18F-fluoride PET imaging.
Study Design Summary: A total of 24 patients with castration-resistant prostate
cancer bone metastases will be enrolled in this companion imaging biomarker study.
It is anticipated that accrual will be completed in 1.5 years with a minimum of 16
patients enrolled in a year. A maximum of six (6) DoD-affiliated institutions that
are ACRIN-qualified for imaging will be participating in this trial.