By Beth Baldwin-Lien, ND: Medical Affairs & Education Director for Vital Nutrients.
Of the nearly 220,800 men expected to be diagnosed with prostatic disease in the United States this year, fewer than 13% will die from this disease.1 Local therapy in the form of radical prostatectomy and/or external beam radiation therapy is intended to be curative, and often is. However, as many as 40% of patients who undergo radical prostatectomy and 50% of those who undergo external beam radiation therapy will experience rising prostate-specific antigen (PSA) levels within 10 years after local therapy.2
This condition is known as biochemical recurrence (BCR), and these patients are faced with uncertainty about when they will develop metastases, as well as a difficult risk-benefit analysis as to when to begin androgen deprivation therapy (ADT). ADT reduces testosterone levels in the body in order to slow tumor growth. For a patient in remission, ADT can reduce the chances of the disease recurring.
To date, no study has shown a survival advantage for initiating ADT at the time of biochemical recurrence, rather than waiting until radiographic metastases are detected. Furthermore, there is evidence of significant harms caused by ADT, including hot flashes, impotence, loss of lean muscle, and increased risks of metabolic syndrome, diabetes, vascular disease and osteopenia. (2,3)
Aside from salvage radiation, there is currently no standard of care for BCR. Options include observation or intermittent ADT. Anxiety has been shown to be an important factor in patients choosing to receive ADT for BCR despite known decreases in quality of life related to this treatment.3
Therefore, the search is underway for non-hormonal, non-toxic treatments to slow the rise of PSA. Various natural agents have been studied for this purpose, including pomegranate juice and fenretinide (a synthetic retinoid derivative). In the fenretinide study, zero of 23 men experienced a PSA decline, indicating that observation alone or treatment with an inactive agent would be expected to result in continued PSA rise for all patients. (3)
Recently, a clinical study evaluated a combination herbal supplement both in prostate cell lines and in a group of men with BCR.3 The study was conducted at the Norris Comprehensive Cancer Center of the University of Southern California, using a patented combination herbal formula developed by oncologist Dr. Jacek Pinski. The formula utilizes eight nutrients and botanicals which had been previously shown in laboratory and clinical research to modulate prostate cell growth. These ingredients included:

  • Green tea extract
  • Saw palmetto fruit extract
  • Selenium
  • Lycopene
  • Genistein
  • Daidzein
  • Vitamin D3
  • Vitamin E

In the lab, three prostate cell lines (PC3, LAPC3 and LNCaP) were incubated with increasing concentrations of the combination herbal formula. A strong dose-dependent anti-proliferative effect was observed in both androgen-sensitive and independent cell lines in vitro, along with suppression of androgen receptor expression.
In the clinical portion of the study, 40 men were enrolled with a median age of 67. All had previously been treated for prostate disease with surgery, radiation, or both. Eligibility requirements included rising PSA and no radiographic evidence of current tumor growth. The treatment regimen consisted of three capsules a day of the combination herbal formula in four-week cycles. Researchers assessed toxicity and PSA levels at the end of the first four-week cycle, and then every two months for up to a year. Anyone showing rising levels of PSA was removed from the study.
Of the 39 subjects who were evaluable, fifteen (38.5%) saw declining levels of PSA at some point during the study. The median duration of PSA stability during the study was 6.4 months.
The combination herbal supplement was considered to be well-tolerated, especially in the context of conventional hormone therapies. Two patients experienced grade 2/3 transaminitis; the only other grade 2 toxicities were hyperglycemia, hypercalcemia and flatulence. Importantly, there were no significant changes in testosterone or dihydrotestosterone.
The authors acknowledge that in this small sampling of men with relatively high Gleason scores and short PSA doubling times at enrollment, their primary endpoint of 50% reduction in PSA was not met. The lack of a placebo control is also a limitation of the study.
However, the in-vitro activity of this combination herbal formula was striking, in both androgen dependent and independent prostate cell lines. This activity was confirmed in the prospective single-arm trial, and the formula was well-tolerated, without effects on testosterone, dihydrotestosterone or quality of life, making it a worthy candidate for further study. Additional study of this agent in a placebo-controlled trial is planned.


References
1. www.cancer.org /cancer/prostatecancer/detailedguide/prostate-cancer-key-statistics
 2. Paller, CJ and Antonarakis, ES. Management of Biochemically Recurrent Prostate Cancer After Local Therapy: Evolving Standards of Care and New Directions. Clin Adv Hematol Oncol. 2013 Jan; 11(1): 14–23.
 3. Dorff, T. B., Groshen, S., Tsao-Wei, D. D., Xiong, S., Gross, M. E., Vogelzang, N., Pinski, J. K.  A Phase II trial of a combination herbal supplement for men with biochemically recurrent prostate cancer. Prostate Cancer Prostatic Dis. 2014 Dec; 17(4): 359-365.


* These statements have not been evaluated by the Food and Drug Administration. This product is not intended to diagnose, treat, cure or prevent any disease.