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ProSafe Forte is a phytochemical composition specially developed by Danor to PREVENT and ameliorate benign prostate hyperplasia (BPH) and prostatic Carcinogenesis.

ProSafeForte capsules contain 300 mg of soy phytochemicals extract that provide 25 mg of soy isoflavones,160 mg of saw palmetto f.f.a. concentrate, 30 mg zinc gluconate, 15 mg of lycopene concentrate that includes 1.5 mg of pure lycopene and 5 mg selenium methionine.

BPH Pathology definition Commonly seen in men above fifty the periuretheral prostate gland grows progressively larger until it can cause variable degree of bladder outlet obstruction. This condition is called benign prostate hyperplasia (BHP). It is believed that the etiology involves alteration in hormonal balance associated with age.

Symptoms
Anatomic prostate hypertrophy, pain and frequent urination

Pathology risks without treatment
Prostate enlargement associated with urinary disturbance and increased chances of getting prostate cancer.

Conventional treatment
BPH is largely treated with finasteride (e.g. Proscar®), a 5a-reducctase inhibitor, drug that blocks male hormones. Caution should be used in patients with liver dysfunction. Side effects can include impotence. Definite therapy is presently surgical.

Soy effects on the pathology
In the West prostate cancer strikes one in 11 men. Asian men also fall victim to the disease; but prostate tumors in the Far East are much lower and a good deal slower growing, and men there die from other causes long before their tumor become lethal. (The average life expectancy for men in Japan is four to five years loner than for U.S. men).

A study published in the Lancet, Nov 1993 assayed the isoflavonoids in plasma of Japanese men and found genistein occurring in the highest concentration. Other studies confirmed these results in other Asian countries. The high genistein level may inhibit the growth of prostatic cancer in Japanese men, which may explain the low mortality from prostatic cancer in Japan and maybe in other Asian countries.

Just as soy isoflavones and other soy phytochemicals [present in ProSafe] may be able to help women fight cancer breast, they also are able to help men stave off or at least survive cancer of the prostate, a gland that produces fluid that carries sperm.

Soy contains at least eight known classes of anti-cancer and cell anti-proliferation components. These include the, protease inhibitors, phytates, phytosterols, saponins, phenolic acids, omega-3 fatty acids, phospholipids (lecithin) and phytoestrogenes isoflavones. These components are present in ProSafe but not in the commonly available soy isoflavones pills or capsules. While most capsules or pills of isoflavones run of the mill products are made from purified and isolated isoflavones and are by and large devoid of the other soy phytochemicals, ProSafe is both an enriched source of isoflavones, yet it is also an excellent source of all the other soy phytochemical and nutraceuticals components, That is the reason why ProSafe is a great deal more suitable source of phytoestrogenes and other soy nutraceuticals than just an isoflavones rich source that do not contain most other soy phytochemicals.

It is now generally accepted that suppression or inhibition of malignant cell transformation from normal cells to cancer cells is caused by the action of the combined soy phytochemicals that are in ProSafe that apparently have a very favorable synergetic effect, acting as estrogen antagonists and anti-androgens, reducing the proliferation of cells and anti-oxidant. The soy phytochemicals are apparently able to block inflammatory responses, act as signal interceptors and thus also meliorate conditions resulting from aberrations in signaling pathways. ProSafe being a complete source of the various soy phytochemicals, that contains components that acts to prevent, ameliorate and heal prostate maladies due to: 1) Its hormonal action 2) Its anti-cell-proliferation action and 3) Its antioxidant activity.

Estrogen, the female hormone, can slow the growth of prostate tumors by interfering with the working of the male hormone testosterone.

Testosterone, like estrogen, has its "good" and "bad" sides. That is, it is needed for the host of male characteristics, from muscles and beards to functional erections. But if a man develops prostate cancer, testosterone can serve to hasten its progression.

Estrogen, however, slows testosterone production and thereby retards tumor growth. In fact, some men with prostate cancer elect to undergo estrogen therapy to treat the disease. The problem is that it has undesirable side effects, including a loss of libido, a diminished ability to achieve and maintain an erection, and a certain amount of breast development.

Numerous studies indicate that soy phytochemicals might primarily influence human prostate cancer development by inhibition of cell proliferation, and delay its metastasis. A study at the University Hospital of South Manchester (UK) found genistein and its metabolite, genistin, to be the most effective phytoestrogenes in inhibiting the growth of prostatic cell lines.

The inhibition of cell growth by genistein and other soy phytochemicals, present in ProSafe, is accompanied by the suppression of the DNA synthesis and the induction of apoptosis.

Epidemiological studies as well as cell culture and animal experiments provide evidence which suggests that genistein and other soy phytochemicals, present in ProSafe, are protective and lowers the risk of prostate cancer during the promotional phase of the disease. Moreover, studies also indicate that soy phytochemicals can also be used as a potent therapeutic agent for treating prostate cancer.

A study published in the Lancet, shows that plant derivatives help to shrink the prostate at least as much as finasteride does, and when given to humans, can block some of the effects of the natural estrogen.

Diverse antioxidants in foods such as soy, tomatoes (lycopene), red wine and tea, as well as certain minerals (e.g., Zinc and Selenium) provide necessary antioxidant resources for the body to control oxidative reactions in the body. The growth, cell proliferation and development of abnormal pre-neoplastic and neoplastic cells also involve oxidation reactions, including the formation of active oxygen or peroxide compounds. To ameliorate prostate BPH or carcinogenic conditions the use of estrogenic-like hormone modulator, as well as antioxidant is required.

   Some related references:

1. . Inhibition of prostate specific antigen expression by genistein in prostate cancer cells, Davis JN; Muqim N; Bhuiyan M; Kucuk O; Pienta KJ; Sarkar FH; Int J Oncol 2000 Jun;16(6):1091-7 2.Soybean phytochemicals inhibit the growth of transplantable human prostate carcinoma and tumor angiogenesis in mice; Zhou JR; Gugger ET; Tanaka T; Guo Y; Blackburn GL; Clinton SK J Nutr 1999 Sep;129(9):1628-35 3.Soybean phytochemicals inhibit the growth of transplantable human prostate carcinoma and tumor angiogenesis in mice. Zhou JR; Gugger ET; Tanaka T; Guo Y; Blackburn GL; Clinton SK J Nutr 1999 Sep;129(9):1628-35 4.Effects of a soybean isoflavone mixture on carcinogenesis in prostate and seminal vesicles of F344 rats. Onozawa M; Kawamori T; Baba M; Fukuda K; Toda T; Sato H; Ohtani M; Akaza H; Sugimura T; Wakabayashi K; Jpn J Cancer Res 1999 Apr;90(4):393-8 5.The inhibitory effect of genistein on the growth and metastasis of a transplantable rat accessory sex gland carcinoma. Schleicher RL; Lamartiniere CA; Zheng M; Zhang M; Cancer Lett 1999 Mar 1;136(2):195-201 6.Soy, disease prevention, and prostate cancer. Moyad MA Semin Urol Oncol 1999 May;17(2):97-102 7.Certain aspects of molecular endocrinology that relate to the influence of dietary factors on the pathogenesis of prostate cancer. Griffiths K; Morton MS; Denis L Tenovus; Eur Urol 1999;35(5-6):443-55 8.Diet and its preventive role in prostatic disease. Denis L; Morton MS; Griffiths K; Eur Urol 1999;35(5-6):377-87 9.Synergistic effects of thearubigin and genistein on human prostate tumor cell (PC-3) growth via cell cycle arrest. Sakamoto K; Cancer Lett 2000 Apr 3;151(1):103-9 10.p53-independent induction of p21 (WAF1/CIP1), reduction of cyclin B1 and G2/M arrest by the isoflavone genistein in human prostate carcinoma cells. Choi YH; Lee WH; Park KY; Zhang L; Jpn J Cancer Res 2000 Feb;91(2):164-73 11.Progress in cancer chemoprevention: development of diet-derived chemopreventive agents. Kelloff GJ; Crowell JA; Steele VE; Lubet RA; Malone WA; Boone CW; Kopelovich L; Hawk ET; Lieberman R; Lawrence JA; Ali I; Viner JL; Sigman CC; J Nutr 2000 Feb;130(2S Suppl):467S-471S 12.Genistein inhibits NF-kappa B activation in prostate cancer cells. Davis JN; Kucuk O; Sarkar FH; Nutr Cancer 1999;35(2):167-74 13.Treatment with soybean-derived Bowman Birk inhibitor increases serum prostate-specific antigen concentration while suppressing growth of human prostate cancer xenografts in nude mice. Wan XS; Ware JH; Zhang L; Newberne PM; Evans SM; Clark LC; Kennedy AR; Prostate 1999 Dec 1;41(4):243-52. Review of recent placebo-controlled trials utilizing phytotherapeutic agents for treatment of BPH. Lowe FC, Dreikorn K, Borkowski A, Braeckman J, Denis L, Ferrari P, Gerber G, Levin R, Perrin P, Senge T. Prostate. 1998 Nov 1;37(3):187-93.



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