A phase II double-blind, randomized placebo-controlled study to determine the efficacy of Coenzyme-Q10 in killing prostate cancer cells in vivo

In recent years, there has been a growing interest in using herbal and nutritional supplements for the prevention of prostate cancer. Products such as selenium, vitamin E, lycopene and more recently Coenzyme-Q10 (CoQ10) have all been implicated as possibly conferring protection against the disease. The main purpose of this study is to determine if CoQ10 has any physiologic effects in human prostate cancer. We will endeavor to determine if ingestion of CoQ10 prior to robotic radical prostatectomy can induce apoptosis in prostate cancer cells and reduce vascularity within the cancerous portions of the gland. The outcomes will be determined pathologically. 1. Background Information of Coenzyme Q10: Coenzyme-Q10 or ubiquinone [2,3-dimethoxy, 5-methyl, 6-decaprenyl benzoquinone] is distributed throughout human tissues, and it is most well-recognized as a crucial component of oxidative phosphorylation in mitochondria. Through this process CoQ 10 converts carbohydrates and fatty acids into ATP to drive cellular processes. Similarly, CoQ10 participates in oxidation/reduction reactions in many other cellular membranes and organelles. In its reduced form CoQ10 is a potent antioxidant and is hypothesized to be involved in free-radical scavenging. CoQ10 was first isolated in 1957 by Dr. Frederick Crane in Wisconsin, who extracted the compound from beef heart mitochondria. It was first studied in the treatment of congestive heart failure and the majority of its notoriety is from cardiovascular studies over the past 14 years. Heart tissue has an extremely high energy consumption rate, thus CoQ10 is highly concentrated in myocardium. Severity of heart failure has been correlated with low levels of CoQ10 in a number of studies. The safety and side effect profile of CoQ10 has been established in these studies and many others conducted around the world. An interesting aside is that in eight symposia from 1976 through 1993, over 300 papers presented by over 200 physicians and scientists from 18 different countries have thoroughly elicited the clinical and biomedical characteristics of CoQ10. 2. Prior Safety and Efficacy Data: Safety and efficacy of CoQ10 has been established in a number of these studies. A study done at Temple University established clinical response in the treatment for cardiomyopathy at blood levels of 2.5pg/mL and higher during therapy without any significant side effects reported. Similarly studies by Mortensen et al. from Denmark reported no adverse reactions to CoQ10 supplementation. CoQ10 is normally present in blood at 1pg/mL. It is believed that CoQ10 in cells is highly functional but that in plasma CoQ10 is nonfunctional, existing in equilibrium between absorption and metabolism. These statements ate derived from studies involving cardiovascular treatment and rely on CoQ10 functioning in the mitochondria and contributing to sub-cellular processes occurring throughout a variety of tissues. However, its free-radical scavenging capability is believed to occur in a non-specific 'tanner and therefore be related to higher serum levels and supposed tissue penetration. The goal for CoQ10 therapy in prostate cancer is therefore to create a biomolecular environment that challenges the growth and progression of prostate cancer cells. 3. Q-Gel® Softsules and rationale for use: In previous studies, to increase the levels to 2pg/mL required at least 100mg/day of supplementation. The desire for serum levels of at least 2pg/mL or higher served as the impetus for initiating research to find a form of CoQ10 that could be readily absorbed and create high plasma levels. A new process called Bio-Solv® improved the dissolution and absoption of