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ARTICLES - STUDIES - REFERENCES
Pilot Study – High Grade PIN (HGPIN) Patient Accrual
Urologists are encouraged to enroll their HGPIN patients into a Pilot Study that intends to monitor clinical response
based on PSA activity. All patients should begin the Peenuts® prostate nutritional formula at 2 capsules per day (best
taken with a meal). Historically, in a small clinical trial of 10 patients, the Peenuts® prostate nutritional formula has
been successful in altering the predictable evolution to prostate cancer in 9 of 10 men (in excess of 5 years
surveillance) as noted by a reduction in PSA (a marker of disease activity). In this study format, repeat biopsies were
not performed based on a sampling bias unique to each diagnostician and number of biopsies performed.
Validation data from the American Association of Cancer Research (AACR) suggests that prostatitis is linked directly to
the evolution of prostate cancer. The Peenuts® prostate nutritional formula has been shown in independent research to
suppress and/or resolve prostatitis based on an evaluation of the expressed prostatic secretion (EPS). This research led
to patent recognition by the USPTO in 2001.
It is hypothesized that prostatitis promotes cellular oxidative stress, consistent with destabilization of normal prostate
cells leading to free radical formation; ultimately contributing to the clinical presentation of cancer. It is interesting
that Toremifene, a selective estrogen receptor modulator (SERM), showed benefit versus HGPIN in a Pilot study and is
currently being considered for a placebo controlled trial. The benefit attributed to Toremifene associated with a
reduction in prostate cancer evolution is highly biased based upon a diagnostic strategy that has a very low specificity
and sensitivity in association with random biopsies.
Entry Qualifications:
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