Feasibility Study of a Novel Diet-Based Intervention for Prostate Cancer

: Our goal is to develop a practical, diet-based intervention for prostate cancer. We plan to implement a randomized clinical trial of a novel dietary intervention that utilizes a central, telephone-based counseling program to promote vegetable intake among prostate cancer patients who are being treated with active surveillance. As part of this trial, we will test whether a gene fusion biomarker will predict disease progression in this patient population. During the first year of the funding period, I accomplished five major tasks. First, I several key organizational components of the trial, including a) writing of the study protocol; b) development of the infrastructure for executing the telephone-based dietary intervention, including personnel and printed materials; c) development of the infrastructure for performing dietary assays, including obtainment of a fluoroscopic detector for measuring dietary biomarkers; d) establishment of the protocols for obtaining and processing patient specimens, including those to be submitted for TMPRSS2:ERG gene fusion analysis; and e) obtainment of IRB approval from UCSD. Second, I published two peer-reviewed manuscripts. Third, I extended my participation in the Cancer and Leukemia Group B cooperative study group. Fourth, through increased participation in CALGB, I expanded the scope of the trial to include twice as many prostate cancer patients as originally conceived. Finally, I helped secure additional funding for performing the trial, including a NCI RO-1 grant. I anticipate that, at the beginning of the second year of the funding period, the trial will open for accrual and testing of the dietary intervention will begin.