Unlike most forms of cancer, early stage prostate cancer is almost completely controllable with total hormone-blocking therapy. The drugs used to contain early stage prostate cancer are FDA-approved, yet a recent survey showed that only a small percentage of urologists are using hormone-blocking therapy properly in treating early stage prostate cancer patients. The published scientific literature has confirmed the failure of radical prostatectomy (surgical removal of the prostate) and external beam radiation therapy to produce an acceptable percentage of long-term, disease-free survival. The severe long-term side effects of these two extensively used conventional therapies are well-documented.

In lieu of radical surgery or external beam radiation, prostate cancer patients may want to consider the Life Extension Foundation's early stage protocols that incorporate combined testosterone and prolactin blockade for temporary control of most prostate cancers. Innovative natural therapies are implemented immediately upon the initiation of hormone-blocking drug therapies.

The goal is to give these natural therapies an opportunity to keep the PSA (prostate specific antigen) measurement at a non-detectable level after the discontinuation of three to nine months of combined testosterone and prolactin blockade. Intermittent hormone-blockade drug therapy is advised for almost all prostate cancer patients, since this greatly enhances the time before prostate cancer cells become androgen-independent.

If your PSA level is less than 11, the odds are that the cancer is confined to the prostate sack. Even if your PSA is greater than 11, there still is a good chance that the combination of FDA-approved hormone-blocking therapy, along with our innovative cancer-treatment protocols, can result in long-term remission. You should institute a three- to nine-month course of complete hormone blockade by using the FDA-approved drug Casodex in tablets, Flutamide in capsules, or Zoladex in pellet form, and then receive an injection of the FDA-approved drug Lupron a week later. This combination therapy should reduce your PSA level to less than 1 after only a few months. Casodex is taken every day and the Lupron injections should be re-administered every three months.

When taking Casodex, it should first be taken orally for one week prior to the an injection of Lupron. Many urologists do not know that Lupron which can cause a temporary prostate cancer cell proliferation if Casodex (or flutamide) is not first given one week prior to Lupron's administration.

For many years, the Foundation has advocated that prostate cancer patients first try three to nine months of complete hormone blockade before considering any permanent therapies. The rationale is to shrink the prostate-cancer volume by inhibiting testosterone production and blocking testosterone receptor sites on prostate cells. Testosterone is responsible for most prostate cancer-cell proliferation. Blocking testosterone will cause an elevated PSA blood reading to drop to virtually zero within two months. The reduced PSA is indicative of a significant drop in prostate cancer cell activity. The prostate specific antigen test is an extremely accurate measure of prostate cancer cell activity, once you have been properly diagnosed with prostate cancer. Peer-reviewed studies show that hormone-blocking therapy instituted before aggressive therapy significantly increases your chances of a cure.

Studies have shown that prolactin also may be involved in prostate growth. A rising serum level of prolactin indicates progression in patients with advanced prostate cancer.

The presence of prolactin receptors in prostate cancer cells may facilitate the entry of testosterone into prostate cells. Since testosterone-blocking therapies do not completely eliminate testosterone from the blood, it is conceivable that prolactin could carry a small amount of residual testosterone into the prostate cells and cause cancer growth. Thus, suppressing prolactin secretion with relatively safe prescription drugs appears to be another method of slowing the progression of prostate cancer.

In a study in the European Journal of Cancer (Vol 31A, No. 6, 1995), the use of a prolactin-suppressing drug (bromocriptine) with flutamide and orchiectomy (surgical removal of the testes) resulted in a 61-percent suppression of primary prostate growth, compared with only a 48-percent reduction with orchiectomy and flutamide alone. After 36 months, 40 percent of the group receiving bromocriptine and orchiectomy/flutamide experienced disease progression, compared with 60 percent in the orchiectomy/flutamide-only group. Most prostate cancer patients, understandably, prefer taking the drug Lupron instead of undergoing testicle removal, and in fact, Lupron may be more effective than orchiectomy.

Prostate cancer patients should have their prolactin levels checked via a blood test. If your prolactin levels are elevated, you should consider one of the following prescription-drug regimens prescribed by a physician:

Bromocriptine, 5 mg one to two times a day; or

Dostinex, 0.5 mg twice a week.

Check your prolactin levels again in 30 days to make sure the drug you choose is, in fact, suppressing prolactin release into your blood from the pituitary gland.

Dostinex is the newest and cleanest drug to use. Dostinex has fewer side effects than the older drugs, is more effective in suppressing prolactin, and requires dosing only twice a week.

The Foundation has been recommending only a three- to nine-month course of Casodex (or flutamide) and Lupron therapy. Prolactin suppression therapy may be continued longer. During this period, it is suggested that innovative natural cancer-control therapies be incorporated to see if long-term remission can be achieved.

In many cases, the PSA stays low after hormone-blocking therapy has been discontinued. If the PSA level does increase again to between 6 and 20, the prostate-cancer patient is encouraged either to go on another three- to nine-month hormone-blocking regimen and alter his natural cancer control regimen, or seek out a permanent solution such as enhanced radioactive seed implantation or cryoablation therapy.

When a permanent remission is sought, it is critical that the prostate-cancer patient have undetectable levels of PSA by previously being on the three- to nine-month hormone blocking therapy regimen. An opposite view comes from doctors who perform enhanced radioactive seed implantation, who have said they do not want too much prostate-cancer shrinkage to occur in response to hormone-blocking therapy because they find they cannot find any tumor tissue to implant the seeds into.

If a person continuously stays on hormone-blocking therapy, after two to four years the prostate cancer cells will mutate to a new form of cancer cell that will not need testosterone to proliferate. Thus, once the cancer cells become "androgen-independent," the prostate cancer is usually out of control and will freely metastasize throughout the body.

In a study published in the Journal of Steroid Biochemistry and Molecular Biology (May 1996), prostate cancer in mice was treated with either continuous hormone-blocking therapy or the intermittent hormone-blocking regimen recommended by the Life Extension Foundation. The results showed that five to six cycles of intermittent hormone blockade were possible before the prostate-cancer cells mutated to a form that did not need testosterone to proliferate. There was an initial 66-percent greater time period of prostate cancer cell control in the intermittent group compared, with the group receiving continuous hormone blockade. In the late term of the study, the mice on intermittent hormone-blocking therapy had an astounding 3.78-fold reduction in their PSA levels, compared with the mice receiving continuous hormone-blocking therapy.

This study showed that continuous hormone-blocking therapy accelerates the rate at which prostate-cancer cells become resistant to testosterone blocking therapy, and that intermittent hormone blockade significantly increases the length of effectiveness of hormone-blocking therapy in the long-term treatment of prostate cancer.

What follows is a brief description of the Foundation's alternative protocols for treating early stage prostate cancer that should be implemented before, during and after combined hormone-blockade therapy:

Prostate cancer patients usually take five 700-mg capsules of Mega Soy Extract three to four times a day. Mega-Soy Extract provides pharmaceutical doses of soy isoflavones such as genistein.

Cancer cells use the enzyme protein kinase as a growth factor. Soy genistein is a potent inhibitor of protein kinase activity. The effects of protein kinase inhibitors on human prostate cell growth have been extensively investigated.

Incidences of prostate cancer are high in the Western world, compared with countries in Asia where soy is consumed as part of the normal diet. soy phytochemicals such as genistein are abundant in the plasma of people living in areas with low cancer incidence.

These phytochemicals protect against cancer via several different mechanisms, including interacting with intracellular enzymes, regulating protein synthesis, controlling growth-factor action, inhibiting malignant-cell proliferation, inducing differentiation, deterring cancer cell adhesion and inhibiting angiogenesis. Animal experiments provide evidence suggesting that both lignans and isoflavonoids in soy may prevent the development of cancer.

Genistein may prevent the expression of metastasic capacity in hormone-dependent cancers. Studies have shown that genistein inhibits proliferation and expression of the invasive capacity of prostatic cancer cells with different invasive potentials. In a cell-culture system, genistein appears to be cytotoxic and inhibitory of prostate cancer cell proliferation.

Genistein's protein-tyrosine kinase inhibiting effects have been identified as a cancer-prevention mechanism. The consumption of soy is associated with a low incidence of clinical metastatic prostate cancer, even in the face of a sustained high incidence of organ-confined prostate cancer. A study examined genistein's effect upon cell adhesion as one possible mechanism by which it could be acting as an anti-metastatic agent. A morphogenic analysis revealed that genistein caused cell flattening in a way that prevented metastatic adhesion of prostate cancer cell lines.

CAUTION: Do not take any soy genistein product 10 days prior, during, or three weeks after any form of radiation therapy. Genistein may protect cancer cells against radiation-induced death.

Additional natural therapies include 4,000 IU of vitamin-d3, four saw palmetto/pygeum extract capsules, and as much of the Foundation's Cancer Treatment protocol, in this book, as possible. The Foundation especially recommends that prostate-cancer patients take four to 10 decaffeinated green tea extract capsules each day.

Epidemiological data suggest that vitamin-d3, obtained from dietary sources and sunlight exposure, protects against mortality from prostate cancer. The most active vitamin-d metabolite, vitamin-d3 inhibits the growth and differentiation of several human prostate cancer cell lines.

Permixon (saw palmetto extract) is a drug used in the treatment of benign prostatic hyperplasia. A study of permixon's androgenic and anti-androgenic effects in the prostatic cell lines showed that it has a clear anti-androgenic action. Pygeum extract also has been shown to specifically inhibit prostate-cell proliferation by inhibiting protein kinase C enzyme activity.

Prostate cancer patients should take a PSA test every 30 days, before and after hormone-blocking therapy is discontinued, to see if the innovative cancer therapies are keeping the prostate cancer under control. Serum calcium blood tests also are suggested to make sure that the relatively high daily doses of vitamin-d3 are not causing toxicity.

There are many prostate cancer patients following the Foundation's protocols with success. Individuals have personal decisions to make, based on a wide range of factors, regarding how they are going to deal with their prostate cancer in the long run. Every prostate cancer patient should consider three to nine months of complete hormone blockade before attempting any form of permanent therapy, such as surgery, radiation, cryoablation, radioactive seeds, etc. For some prostate-cancer patients, complete hormone-blocking therapy results in a long-term remission without the need of incorporating any additional therapies.

For those seeking a permanent remission, there is a therapy that combines enhanced ultra-sound guided radioactive seed implantation and external beam radiation aimed only at the implanted seeds in the prostate and seminal vesicle tissue. The seeds provide a greater amount of cancer cell-killing radiation directly to prostate-cancer cells, while serving as an easy target for conformal external beam radiation therapy. Since the external radiation beam hits only the areas that have been "seeded," the long-term complication of rectal and bladder radiation damage is largely avoided, and the areas identified as having cancer cells are intensely irradiated.

As noted, during radiation therapy it is crucial that all soy supplements be discontinued since soy produces a specific mechanism that can protect cancer cells from radiation-induced death. Discontinue soy at least 10 days before radiation, during radiation, and for at least three weeks afterward.

During radiation therapy, the use of high doses of antioxidants will protect healthy cells from free radical-induced radiation damage.

The combination of enhanced ultrasound radioactive seeding with precision external beam therapy is available at the clinic of Dr. Frank A. Critz in Decatur, Ga. Dr. Critz's phone number is 404-320-1550. This therapy also has been instituted at the University of Miami (Fla.) Medical School, and may be available in other hospitals.

The following represents the latest findings about conventional diagnosis and treatment of prostate cancer:

1. Tests to measure PSA density and percent of free PSA were performed on men with total PSA levels ranging from 4.1 to 10. In those with benign prostate disease, the median PSA density was 0.14, compared with 0.19 in prostate cancer patients. The median percent of free PSA was 18.9 in benign cases, compared with 10.1 in prostate cancer cases. This study showed that the use of PSA fractionated testing could detect at least 95 percent of prostate cancers and reduce the need for biopsies by 26.9 percent in men who did not have prostate cancer. These PSA fractioned tests are expected to become more widely available in the near future.

2. A significant false-negative rate for initial transrectal ultrasound guided prostate was shown in a study of 130 men. Needle biopsies of the prostate gland missed 23.8 percent of cancer cells detected by a second needle biopsy. The doctors who conducted the study suggested that repeat biopsies be done for patients in whom the initial biopsy is negative. The Life Extension Foundation interprets this study to validate greater use of the PSA fractionated tests showing free PSA and PSA density, in order to rule out men who do not need a biopsy at all.

3. Prostate tumors that recur locally after radical prostatectomy (surgical removal of the prostate) appear to have a higher proliferative rate, compared with the tumors removed during the radical surgery. Tumor proliferative rates were measured in 26 patients. Before radical prostatectomy, the mean proliferation labeling index was 2.96. After surgical removal of the prostate gland, the mean labeling index increased to 6.47-a 64-percent increase in cancer-cell proliferation.

4. A randomized trial of 415 patients with locally advanced prostate cancer showed an 85-percent disease-free survival after five years in patients receiving Zoladex and external beam radiation therapy, compared with only a 48-percent disease free survival rate in patients receiving external beam radiation therapy alone. Zoladex is an FDA-approved drug that functions in a similar way as Lupron to suppress testosterone secretion. This study adds to the growing number of studies showing hormone blockade as an effective prostate cancer therapy, either by itself or in assisting other therapies. The Life Extension Foundation's protocol suggests additional hormone-blocking therapies be used along with Zoladex or Lupron.

5. A total of 200 cases were analyzed to determine accuracy of staging (determining the distinct phases) of prostate cancer. The addition of magnetic resonance imaging (MRI) was shown to enhance tumor-staging accuracy.

6. 3-D conformal radiotherapy was shown to cause few serious long-term side effects, compared with those expected from external beam radiation therapy. When 3-D conformal radiotherapy was used as a primary therapy, patients with a PSA greater than 10 at diagnosis had a significantly shorter period of disease-free survival, compared with patients whose PSA was less than 10. Patients with Gleason scores of 7 and above also had a significantly lower disease-free survival period.

7. Vitamin-d3 was shown to induce prostate cancer cell apoptosis (programmed cell death) via several mechanisms. One newly identified action of vitamin-d3 on prostate cancer cells was the translocation of the androgen receptor, thus making these cells less susceptible to proliferation stimulation by testosterone.

8. Hormone-blockade therapy was shown to reduce prostate volume by about 30 percent. Prostate cancer cells responded much more favorably to hormone-blocking therapy than non-cancerous prostate cells. The results suggest that hormone blockade downsizes, and in some cases down stages, prostate cancer cells. Down staging of prostate cancer cells could result in a significant long-term remission.

9. Statistically significant rises in PSA levels were observed in men who had undergone cardiac surgery. The doctors speculated this was caused by a lack of blood flow to the prostate gland during surgery, resulting in ischemic damage to prostate cells that caused them to secrete PSA.

10. A study looked at patients with a mean age of 63 and a mean PSA of 8.6. Forty-six percent were found to have organ-confined prostate cancer, 25 percent had infiltration of cancer cells into the fatty sack containing the prostate gland, and 7 percent had seminal vesicle involvement. At surgery, 46 percent had positive margins, indicating that the cancer had spread beyond the prostate gland. When these patients were sub-grouped, those with a PSA under 10 were much more likely to have organ-confined disease.

11. There was a 27-percent failure rate at five years in men whose PSA was between 8 and 15, and with Gleason scores between 2 and 7 who were treated with external beam radiation alone. The doctors concluded that hormone-blocking therapy may have prevented this high failure rate in these men who had a relatively early stage of prostate cancer.

12. When CT evaluation of prostate tumor volume is performed, an enhancement of visualization occurred in 15 of 16 patients when intravesical contrast was used. Without the use of intravesical contrast, significant underestimating of the tumor volume occurred, which could lead to treatment failure.

13. The free radical-generating fatty acid called arachidonic acid was shown to stimulate prostate cancer cell growth. The molecular pathway of arachidonic stimulation involved the inflammatory enzyme 5-lipooxygenase. Lipooxygenase also is involved in the formation of abnormal blood clots (thrombosis). Nutrients that specifically inhibit 5-lipooxygenase include garlic. Drugs that are beneficial include ibuprofen and aspirin. Fish oil supplements in high doses have been shown to suppress arachidonic acid formation.

14. Prostaglandins are synthesized from arachidonic acid by the enzyme cyclo-oxygenase. A particularly dangerous prostaglandin is PGE2, which is involved in many chronic inflammatory diseases. The administration of PGE2 to prostate, breast and colon-cancer cells resulted in increased cellular proliferation. An ibuprofen derivative called flurbiprofen inhibited PGE2-induced prostate cancer cell growth. Aspirin, ibuprofen and fish oil are several available agents that inhibit PGE2 synthesis.

15. In advanced, hormone-refractory (not readily yielding to treatment) prostate cancer, the chemotherapy drug mitoxantrone, in combination with a prednisone or hydrocortisone, showed clinical benefits in 35 to 40 percent of patients. Quality of life improvements where noted with less toxicity encountered, compared with traditional chemotherapy drugs. The administration of mitoxantrone, however, did not result in increased survival compared to corticosteroid drugs being used alone.

16. As many as 80 percent of 80-year-old men were shown to have prostate cancer cells present at autopsy, but only 10 percent of them will ever be diagnosed with it, and only 3 percent will ever die from it.

17. Pygeum africanum extract, sold under the trade name Tadenan as a drug in Europe, is used to treat the urinary symptoms of BPH. In a study conducted in rats, pygeum extract was specifically shown to inhibit the benign proliferation of prostate cells. One mechanism of suppression of prostate cell growth was the inhibition of protein kinase C, an enzyme involved in both benign and malignant cell over-proliferation. Soy genistein also is a potent inhibitor of protein kinase C.

18. Doctors report on a patient whose prostate cancer had become hormone-refractory. Flutamide withdrawal, along with the addition of hydrocortisone, has resulted in a 46-month period of total remission. There is currently no evidence of prostate cancer in this patient. Repeat biopsies that had previously showed positive are now negative. The doctors believe that this one case, and the results of previous published studies, indicate that flutamide withdrawal and hydrocortisone therapy is an option for the hormone-refractory disease in the advanced-state prostate cancer patient.

19. A total of 274 men completed questionnaires about their quality of life after radical prostatectomy and external beam radiation. The conclusions from the questionnaires showed that men who had undergone these radical conventional therapies experienced difficulty long after treatment. In this study, the prostatectomy group fared worse as far as sexual and urinary functions, whereas the radiation therapy group experienced more bowel dysfunction.

20. Prostate cancer was detected in 22 percent of men 50 years or older whose PSA reading was between 2.6 and 4. All cancers detected were clinically localized. This study indicates that PSA readings greater than 2.6 may represent a 22-percent risk of prostate cancer. The use of a free PSA test would help determine which of these men whose PSA readings were greater than 2.6 had prostate cancer; such a test could thus reduce the number of unnecessary biopsies.

21. In men with PSA levels greater than 10, and/or Gleason scores equal to or greater than 7, only 60 to 84 percent were free of PSA-measured disease progression three years after conventional therapy. This study indicated the need for adjuvant (assisting) therapies such as hormone blockade.

22. Over a five-year period, prostate cancer patients whose family members also had the disease had a relapse-free survival rate of only 29 percent, compared with relapse-free survival rate of 59 percent in similarly staged prostate cancer patients whose family members did not have prostate cancer. These findings show that familial prostate cancer may be more aggressive than non-familial forms, and that standard clinical and pathological measurements may not adequately predict this course.

23. In men with advanced metastasized prostate cancer (stage D1 and D2) who were previously untreated, combination therapy utilizing Lupron, flutamide, and pharmaceutically administered suramin produced an overall positive response rate of 67 percent. There were three complete responses in this trial of 48 patients. There were 18 deaths reported in this group.

24. A new term, "anti-androgen withdraw syndrome," has been coined to deal with prostate cancer patients who become refractory (resistant) to hormone-blockade treatment. It appears that upon withdrawal of flutamide, Casodex, and other similar drugs, the PSA level goes sharply down. The doctors advocate a trial of anti-androgen withdrawal therapy prior to the initiation of toxic therapies.

25. If combined hormone therapy begins to fail-that is, if the PSA level starts to elevate or symptoms of disease progression occur-substituting Casodex for flutamide, or visa versa, may buy additional time before hormone-blockade therapy is no longer effective.

26. It may be possible to reduce the dosage of flutamide and still receive the same benefits while minimizing potential side effects. Those who have been on flutamide one to two years may consider reducing the dose to one 125-mg tablet every eight hours, or eliminating it altogether.

27. Dihydrotestosterone may be five times more potent in promoting prostate cancer cell growth than testosterone. Some doctors are using low-dose Proscar drug therapy in varying combinations with other hormone-blocking therapies. Proscar may be a more specific inhibitor of dihydrotestosterone than saw palmetto extract. While saw palmetto has been shown to work equally as well or better than Proscar in treating BPH, saw palmetto may interfere with benign prostate cell growth by mechanisms other than direct dihydrotestosterone suppression. More studies are needed to validate the benefits of Proscar in treating prostate cancer.

For more information please visit: www.prostate-cancer.org

Product availability: Mega Soy Extract, Soy Power, Green Tea Extract, vitamin-d3 capsules, PC Spes and pygeum/saw palmetto extract can be ordered by phoning 1-800-544-4440 or order OnLine