LONDON, UK (GlobalData), 11 April 2012 - To many people, the idea of using an over-the-counter supplement to treat prostate cancer is laughable. The American Cancer Society warns against such a practice, stating that such alternative treatments are rarely shown to have any clinical efficacy and may do more harm than good. However, a number of currently active clinical trials are exploring the benefits of dietary supplements to prostate cancer patients. Data from these trials may drastically change public opinion on the merits of such treatments. Armed with clinical evidence of efficacy, safety and minimal side effects, these dietary supplements may have the potential to infiltrate the prostate cancer treatment algorithm.
The dietary supplement Prostate Health Cocktail (PHC) has the potential to become an alternative option to androgen deprivation therapy (ADT) for men with recurrent prostate cancer. PHC is produced by OncoNatural Solutions, Inc., and is a combination of nutrients, minerals, herbs and vitamins. According to the company, each ingredient in PHC was independently shown to prevent prostate cancer development, kill prostate cancer cells, or improve the symptoms of benign prostate cancer enlargement. By enrolling patients in an FDA approved Phase II clinical trial studying the effects of PHC on prostate serum antigen (PSA) levels, the company is taking a critical step to foster the credibility of its product. The repute of PHC is also boosted by the reputation of its developer, Dr. Jacek Pinski, MD, PhD. His experience as co-Director of the Prostate Cancer Research Program at the University of Southern California (USC) Norris Comprehensive Cancer Center and Hospital (which has no stake in the company, but is sponsoring the clinical trial) will certainly help strengthen the perception of legitimacy that PHC needs in order to be considered as a valid treatment option. While safety data has not yet been reported, it is highly unlikely that PHC will have severe side effects as all of its ingredients are already available as over-the-counter dietary supplements. According to OncoNatural’s website, ingredients in the PHC cocktail include epigallocatechin (green tea), lycopene, saw palmetto, genistein, selenium, and vitamins D and E.
According to a press release in April 9, 2012, preliminary data showed that PHC stabilized the PSA levels in 83% of men who had previously undergone radiotherapy or radical prostatectomy. The single-arm study examined whether treatment with PHC alone (3 times daily) could stop PSA levels from increasing in men whose PSA levels continued to go up following localized treatment. In general, stabilization of PSA levels is not as clinically reliable as improvement in overall survival. However, since increasing PSA levels are often correlated with disease progression, the FDA still considers it a valid endpoint representing clinical benefit in Phase II trials. With only 28 participants enrolled, the current trial is quite small, which will limit the reliability of the final data. However, the well-defined study design helped to compensate for the small sample size. The study criteria included stipulations on the duration between initial cancer treatment(s) and the start of PHC treatment, the types of previous treatments that were allowed, the staging of the disease, and the initial PSA levels and doubling time.
There is currently no curative option for men with prostate cancer once surgery and/or radiotherapy have failed. ADT, while overwhelmingly the treatment of choice for this stage of prostate cancer, is far from perfect. It is costly, has a number of unpleasant side effects, and over time prostate cancers become androgen independent which renders ADT useless. GlobalData spoke with a representative from OncoNatural Solutions who maintains that PHC is not designed to replace current treatments. But the reality is that the weaknesses of ADT provide ample room in the market for another palliative treatment like PHC that is cost effective and likely free from harmful side effects. It remains to be seen whether PHC can extend the overall survival of patients comparatively to ADT. The representative could not confirm to GlobalData if OncoNatural Solutions was interested in launching any additional studies. However, we believe that if the current trial continues to be successful (as these results are preliminary); a Phase III clinical trial with a primary endpoint of increased overall survival is on the horizon. If such data were positive, it would easily position PHC to encroach on the market share currently dominated by AstraZeneca’s Zoladex and Casodex, and Abbott’s Lupron.
Even if future trial results for PHC are positive, it will not be easy for OncoNatural to successfully market an OTC “nutraceutical” like PHC as a treatment option for a life-threatening disease. PHC must first shed the inevitable stigma that dietary supplements are significantly less effective than pharmaceuticals for treating serious, complex diseases such as cancer. This will not be an easy task; studies have long suggested the benefits of taking vitamins and minerals for the prevention of various diseases, but nutraceuticals are yet to claim solid ground in the treatment regimen of a high-stakes ailment like cancer. However, with enough valid clinical evidence and a market hungry for inexpensive new solutions, GlobalData believes supplements like PHC are capable of changing the minds of both clinicians and consumers.
*Prostate Health Cocktail: Not Your Average Vitamins!
This expert insight was written by Dr. Cheryl Strelko, Oncology and Infectious Diseases Analyst for GlobalData. If you would like an analyst comment or to arrange an interview, please contact us on the details below.
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