PROTOCOL SPECIFIC MATERIALS
ACRIN 6687 Imaging Materials
 
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)
 

Protocol Documents

Principal Investigator:  Evan Y. Yu, MD

Status:  Closed

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 
(dhartfeil@acr.org; 215-717-2765).  

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
and BMS.

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.