The Prostate Health Cocktail in management of biochemically recurrent prostate cancer

A newly published paper by some highly regarded researchers provides data from a small, Phase II trial of Prostate Health Cocktail (PHC) — an “over-the-counter” combination herbal supplement — in the management of biochemical recurrence of prostate cancer.

There is absolutely no doubt that we would all like to see the development of an effective and safe, over-the counter (or prescription), non-hormonal treatment that could be used to counter prostate cancer: in any way, shape, or form. To date, however, no known product of this type has ever demonstrated a high degree of efficacy, although several appear to be quite safe … but safety without reliable efficacy is not exactly the answer we are looking for.

Thus, it is always gratifying to see actual data from respected researchers that attempt to provide guidance on the effectiveness and safety of the products that are available on the market (and are often “touted” to prostate cancer patients who are desperate to avoid the well-known problems associated with androgen deprivation therapy [ADT]).

Dorff et al. report on a two-part study of the effects of PHC: an “in vitro” laboratory study of the anti-proliferative effects of the supplement and an actual clinical trial in a small group of patients.

With respect to the laboratory part of the study, the researchers incubated (grew) three different types of prostate cancer cell in a series of increasing concentrations of a PHC suspension. They were able to demonstrate that PHC did, quite certainly, have “a strong dose-dependent anti-proliferative effect” in both androgen-sensitive and androgen-independent cell lines in vitro and in suppression of androgen receptor expression — in other words, it does seem to work in the laboratory.

With respect to the clinical part of the study, the findings were as follows:

  • The study enrolled 40 men with a rising PSA after various forms of prior treatment (not specified in the paper’s abstract)
  • The average (median) PSA of patients at study entry was 2.8 ng/ml (range, 1.1 to 84.1 ng/ml).
  • 15/40 patients (38 percent) exhibited a decrease in their PSA level (by 1 to 55 percent).
  • 25/40 patients (62 percent) exhibited a rising PSA on study.
  • The median duration of PSA stability was 6.4 months.
  • Two patients had grade 2/3 transaminitis.
  • Other grade 2 toxicities were hyperglycemia, hypercalcemia, and flatulence.
  • No significant changes in testosterone or dihydrotestosterone levels were observed.
  • 19/40 patients (47 percent) were seen to have circulating tumor cells (CTCs).

The authors conclude that:

  • The study’s primary endpoint (a 50 percent decline in the patients’ PSA levels) was not met.
  • PHC treatment was generally well tolerated.
  • PHC treatment was associated with PSA declines and stabilization in a significant number of patients.
  • This appears to be the first report of the detection of CTCs in men with biochemically recurrent prostate cancer.

The authors are careful to point out that randomized clinical trials would be needed to define the real clinical effects of PHC in men with biochemically recurrent disease (since treatment with a placebo might also lead to a declining PSA in as much as 38 percent of a comparable study population).

When data from this study were initially presented, earlier this year, the manufacturer of PHC issued (as a media release) a rather more positive interpretation of the results of this trial. Having said that, it does appear as though some men may be able to delay a rise in their PSA through the use of this product. Whether this delay in the rise of their PSA level is of any clinical importance whatsoever is unknown, but it is clear that use of PHC does have side effects, so use of this product comes with certainty of risk but no certainty about benefit.

3 Responses

  1. The word cocktail prompts me to wonder if there are studies which looked at whether ethanol consumption has any effect on progression of recurrent prostate cancer.

  2. One ingredient in the PHC is vitamin E, which other studies have shown to have a negative impact for those with existing prostate cancer. Vitamin E … apparently … can make existing prostate cancer even more aggressive.

  3. Dear Dr. Hanline:

    I am not aware of any really sound study (of even a retrospective, epidemiological nature) that was able to isolate alcohol consumption from all of the other potential risk factors as a risk for progressive disease post-treatment.

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