This phase II trial studies whether BroccoMax reduces the serum level of palmitic acid in patients with prostate adenocarcinoma. Sulforaphane is a natural chemical found in vegetables like broccoli and is part of our natural diet. Fatty acids are the building blocks of the fat in bodies and in the food people eat. Increased fatty acid level is a unique feature of human prostate cancer. Sulforaphane may decrease fatty acid levels in prostate cancer.
Study sponsor and potential other locations can be found on ClinicalTrials.gov for NCT03665922.
PRIMARY OBJECTIVE:
I. To determine whether daily oral broccoli sprout/broccoli seed extract supplement (BroccoMax) intake for 4 weeks decreases serum levels of palmitic acid (PA), the primary free fatty acid, through a pilot double-blind, randomized, and placebo-controlled window of opportunity trial in 40 subjects scheduled for prostatectomy.
SECONDARY OBJECTIVES:
I. To evaluate if BroccoMax intake for 4 weeks is safe.
II. To determine if daily oral BroccoMax intake for 4 weeks prior to prostatectomy can lead to detectable serum, urine and prostate adenocarcinoma levels of sulforaphane (SFN) and its metabolites.
III. To explore if daily oral BroccoMax intake for 4 weeks prior to scheduled prostatectomy decreases mean proliferative index (Ki-67) but increases apoptotic marker (TdT-mediated dUTP nick end labeling assay [TUNEL]) in prostate adenocarcinoma sections compared to placebo arm.
IV. To explore if daily oral BroccoMax intake for 4 weeks prior to scheduled prostatectomy decreases prostate adenocarcinoma expression of fatty acid synthesis enzyme proteins (ACC1, FASN, and CPT1A), and their regulators including AR, PTEN, SREBP-1, and c-Myc by immunohistochemistry (IHC).
V. To explore if daily oral BroccoMax intake for 4 weeks in subjects prior to scheduled prostatectomy affects serum and prostate adenocarcinoma levels of fatty acid metabolism intermediates like acetyl-CoA, malonyl-CoA, total phospholipids, and ATP, and fatty acid profile by global lipidomics.
OUTLINE: Patients are randomized to 1 of 2 arms.
ARM I: Patients receive BroccoMax orally (PO) twice daily (BID) for 4 weeks in the absence of disease progression or unacceptable toxicity.
ARM II: Patients receive placebo containing microcrystalline cellulose PO BID for 4 weeks in the absence of disease progression or unacceptable toxicity.
After completion of study, patients are followed up at 6 weeks post-surgery and then every 3 months thereafter.
Lead OrganizationUniversity of Pittsburgh Cancer Institute (UPCI)
Principal InvestigatorBruce L. Jacobs
