Peenuts - natural solutions to prostate cancer ..... Preferred Health Resources
Peenuts is physician tested and physician endorsed ------- Peenuts Alternative treatment for prostate cancer. Peenuts is a unique, synergistic, proprietary blend of vitamins, minerals, herbs, and amino acids. It has undergone a prospective, randomized double-blind study with placebo control.
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Prostate Speakeasy ... About Dr Wheeler
Improved systemic and prostate health through the synergistic blend of antioxidants, immune boosters, anti-inflammatories, and beta-sitosterols Prevent Prostate Cancer through the mechanism of cellular anti-oxidation as validated by decreasing the number of white blood cells in the EPS (expressed prostatic secretion) Goals of Peenuts: Improve your stream size and strength - Eliminate or improve lower urinary tract symptoms - Improve sex drive and performance
Eliminate the need for unnecessary prostate biopsy by improving the health of the prostate as validated by a lower PSA (memo: the #1 reason that PSA rises is secondary to a non-bacterial inflammatory condition called Prostatitis). Prevent the need for future prostate surgery for BPH (prostate enlargement) Prevent Prostate Cancer through the mechanism of cellular anti-oxidation as validated by decreasing the number of white blood cells in the EPS (expressed prostatic secretion) The Ultimate Male Formula
Eliminate or improve symptoms of prostatitis
..... ...... Assist men with known Prosate Cancer, who are currently on a modified watchful waiting approach or who have had radiation therapy (Brachytherapy or External Beam) or Cryosurgery
Dr Ronald E. Wheeler
Ronald E. Wheeler
A message from Dr. Wheeler
Based in Sarasota, Florida
   

Prostate cancer prevention
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 Prostatitis & Prostate Cancer Center
 
Physician Tested • Scientifically Validated.



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