Peenuts Trial A Randomized, Placebo-Controlled, Double Blind
Study
Prospective, Randomized, Placebo-Controlled, Double Blind Study
Evaluating for the Benefit of Peenuts ®, versus Voiding Symptoms
The Voiding Symptom Score (IPSS-Index) is a diagnostic measure used
to assess one's ability to effectively empty the bladder by asking 7
questions addressing the pattern of urination including: Frequency,
Urgency, Incomplete Emptying, Intermittency, Straining, Weak Stream
and Nocturia (Validated by the AUA in 1997). The statistical
analysis of the comparative between Group A (active product) and
Group B (placebo) using this validated diagnostic measure is
demonstrated below.
ProCap Trial - (A Prostate Cancer Prevention Trial)
Format:
Randomized
Double Blind
Placebo Controlled
Age Matched
Trial Accrual:
1000 Patients divided between the
placebo and the active formula performed at multiple Veterans
Administration Clinic Sites (actual number of entrants will depend
upon a statistical significance associated with the projected
outcome that the study is powered to measure)
Trial Entry:
Men Aged 40-69 years old (3 Decades
Represented)
Trial Qualification:
•No Evidence of Prostate Cancer based on
Digital Rectal Exam
•PSA must be = 1.0 ng/ml, but less than 4.0 ng/ml;
a PSA of 4.1 ng/ml-6.5 ng/ml would also qualify if there is a
preceding biopsy that validates a lack of cancer
•IPSS-Index (International Prostate Symptom
Score Index)
Trial Variables:
1.
Prostate Specific Antigen (PSA)
using Quest Diagnostics
2.
Digital Rectal Exam
3.
International Prostate Symptom Score Index
Frequency of Office Visits:
Every 6 Months (Evaluate and record all Variables)
Study Trial Endpoint:
Prostate Cancer Diagnosis
Length of Study Trial:
5-7 years
Study Guideline:
In the event that men evaluated note a change in
PSA (velocity change) or digital rectal findings that support suspicion
for prostate cancer, a prostate biopsy will be performed following a
complete consented disclosure. In the event the biopsy is negative the
patient will be returned to the previously assigned treatment arm while the
diagnosis of prostate cancer will prompt immediate consideration and/or
implementation of appropriate valid treatment options.
Funding:
Private Resources Requested (Opportunity to Create a Legacy through a
Foundation Donation)
Premise:
Prostate disease is the number one health risk that an adult male will
face with 82 men dying daily from this menacing disease while a new case of
prostate cancer is diagnosed every three minutes (reference: American
Cancer Society). Based upon scientific data, it is believed that a patented
prostate nutritional formula (Peenuts ®,) will provide a major health care
benefit. Specifically, Peenuts ®, is expected to
decrease the pool for
prostate biopsy candidates based on eradication of prostatitis as a
sentinel disease that many experts believe is associated with the evolution
of prostate cancer (reference: American Association of Cancer Research).
Improvement in
prostatitis will be noted by a reduction in PSA (prostate specific
antigen), a surrogate marker for prostatitis. Therefore, it is believed that
a reduction in prostatitis (non-bacterial inflammation) will lead to a
decrease in the diagnosis of prostate cancer. To reiterate, the expectation
is noted for the Health Care system to benefit through a reduction in
unnecessary prostate biopsies associated with a reduction in PSA, improved
patient health anticipated with improvement in voiding abilities, with an
ultimate decrease in the incidence of prostate cancer (validated by study
design).
Background Data:
Prostate disease is the number one health risk that men face associated
with prostate enlargement (benign prostatic hyperplasia), prostatitis
(inflammation of the prostate), and/or prostate cancer. All diseases of the
prostate are epidemic individually and collectively. 50% of 50 year old men
have evidence of benign
prostatic hyperplasia (BPH), while the signs and symptoms are the number
one reason that men visit the doctor (reference: McNaughton-Collins).
Voiding symptoms common to BPH are also common to prostatitis. In a clinical
trial presented at the National Institute of Health in 1999, 235 consecutive
men with any level of voiding symptoms were evaluated clinically for
prostatitis. Prostatitis was noted to be present in 81% of men less than 50
years old (n=83) while 88% of men 50 years old or older (n=152) were noted
with the disease (reference: R. Wheeler).
PSA (prostate
specific antigen) represents the most dominant male health disease
marker associated with BPH, prostatitis, and prostate cancer. Data from
Johns Hopkins, associated with the Baltimore Longitudinal Study, notes that
men aged 40-60 years with a PSA reading of greater than 0.6-0.7 ng/ml have a
3-4 fold increased risk for prostate cancer within their subsequent 20
years. In a separate study, Gann and Hennekens noted a 5-9 times increased
risk for the evolution of an aggressive cancer within the subsequent 10
years when the PSA was identified between 2-4 ng/ml. It is further noted
that 30% of 30 year old men have prostate cancer, adding an inordinate
amount of stress to an already beleaguered health care system (reference:
The Detroit Autopsy Study). While the search for novel, cost effective
prostate cancer diagnostic and treatment models continues, the cost of
needless prostate biopsies, based on the PSA blood test primarily, costs the
health care system in excess of 1.5 billion dollars. The most significant
portion of these costs would likely be eliminated by the resolution of
prostatitis. Prostatitis, primarily a non-bacterial event, is the number one
reason that PSA rises and arguably the prime culprit in why men are asked to
undergo a prostate biopsy. Minimizing the impact of prostatitis would prompt
a quantum shift in health care expenditure to the cost savings side as the
majority of the 70-80% of the negative biopsies could be avoided.
Additionally, as prostatitis is resolved, annoying symptoms that prompt men
to visit the doctor may also be eliminated.
A proposed prostate cancer prevention trial comparing a patented,
synergistic blend of natural ingredients for the prostate versus a placebo
in a randomized, double blind, age matched study is expected to alter the
landscape of disease understanding. Peenuts ®,, a
prostate nutritional formula was chosen for study consideration based on
its patent status and effectiveness in reduction of signs and symptoms
associated with prostatitis reported through clinical evaluation. Peenuts
®,, a synergistic blend of vitamins, minerals, herbs and amino acids
(including Vitamin E and Selenium), is associated with anti-inflammatories,
immune boosters, antioxidants and beta sitosterols. Peenuts ®, has been
validated previously to reduce voiding symptoms in a randomized, placebo
controlled, double blind study. The study findings were statistically
significant. Reasons for enhanced academic excitement is furthered by the
mid-term results of a prospective study evaluating the benefit of the
Peenuts ®, formula with diet in men with known prostate cancer. At an
average of 30 months, prostate cancer is suppressed in 90% of the study
participants. This is a sentinel finding as it demonstrates that men can now
safely live with prostate cancer similarly to living with rheumatoid
arthritis, diabetes or hypertension. The overall effect on the health care
budget could be monumental as 50-60% of men with prostate cancer have
characteristics similar to the men studied in the prospective trial.
The ability of nutritional ingredients to have an impact on the evolution
of prostate cancer is well chronicled in the literature through the Alpha-tocopherol,
Beta-carotene (ATBC-Finnish Study) and through the work of Larry Clark, PhD
at the University of Arizona who evaluated the benefit of Selenium on
prostate cancer. Vitamin E (50 IU) was noted to decrease the incidence of
prostate cancer by 34% while Selenium (200 mcg) was noted to decrease the
incidence of prostate cancer by 66%. Currently, the NCI (National Cancer
Institute) is attempting to corroborate the benefit of these two ingredients
separately and in combination through the Select Trial. Anticipated
completion date is 2012.
Notwithstanding the benefits outlined with the Select trial, it is felt
that if the Peenuts ®, formula can suppress and/or
stabilize all cases of prostate cancer in the prospective study, it may
be possible for this formula to prevent prostate cancer. The mechanism of
action with the Peenuts ®, formula is believed to be associated with the
resolution of prostatitis through a decrease in cellular oxidative stress.
Beyond an expected decrease in anxiety as the PSA decreases, voiding
symptoms are expected to improve as the expected number of doctor visits is
expected to drop.
While the health care budget is strained due in part to the diagnosis and
treatment of prostate cancer, the ability to prevent prostate cancer gives
men an improved opportunity to extend their quality of life while saving the
health care system hundreds of millions of dollars, if not, billions. Beyond
the expected prevention of prostate cancer (the ultimate goal of the study),
the number of biopsies requested is expected to drop precipitously with an
anticipated decrease in PSA level with the Peenuts ®, formula when compared
to placebo. Presently, in excess of 1.6 billion dollars are spent yearly on
prostate biopsy with the majority of procedures performed based on an
elevation of PSA alone. Despite our best efforts, only 20-30% of biopsies
yield a cancer, suggesting our current model for biopsy consideration
qualifies men excessively and inappropriately.
A gateway to an improved health care model for men has been proposed. This
study is about more than altering a disease course…it is about altering or
eliminating the number one health threat for every adult male while ensuring
a healthier, more productive society. The only remaining challenge is to
locate the financial commitment to fund the study. Finding a person(s) or
organization to embrace this noble project remains difficult despite an
anticipated outcome that promises to tame an epidemic and foster wellness
for all men.
Respectfully submitted,
Ronald E. Wheeler, M.D.
Medical Director of the Diagnostic Center for Disease
These statements have not yet been evaluated by the Food and Drug Administration. These products are not intended to diagnose, treat, cure, or prevent any disease. SunVita Nutrition
583 Interstate Boulevard Sarasota FL, 34240 (888)733-6887 Contact Customer Service: info@sunvitanutrition.com
