US 2007004.1994A1 (19) United States (12) Patent Application Publication (10) Pub. No.: US 2007/004.1994 A1 McDowell, JR. (43) Pub. Date: Feb. 22, 2007

(54) COMPOSITIONS AND METHODS FOR Publication Classification TREATING PROSTATE DSORDERS (51) Int. Cl. A6IR 36/85 (2007.01) (75) Inventor: John W. McDowell JR. Rehoboth, DE A6IR 36/06 (2006.01) (US) (52) U.S. Cl...... 424/195.15; 424/774

Correspondence Address: (57) ABSTRACT UANET M. KERR P.O. BOX 60 Compositions and methods are described for the treatment TAYLORS ISLAND, MD 21669 (US) of prostatitis, benign prostatic hypertrophy, and prostate cancer. The compositions contain either aqueous extracts or dried mixtures of selenium- and zinc-enriched cannabis (73) Assignee: SLGM Medical Research Institute plant material, Shiitake mushrooms, and maitake mush rooms. The compositions are effective in treating prostate disorders by alleviating pain and Voiding symptoms, (21) Appl. No.: 11/207,700 decreasing inflammation and prostate size, reducing cellular proliferation in prostate tissue, and/or reducing PSA levels (22) Filed: Aug. 20, 2005 to within the normal range of 0-4. US 2007/004. 1994 A1 Feb. 22, 2007

COMPOSITIONS AND METHODS FOR TREATING 0007 Benign prostatic hyperplasia (BPH) is a noncan PROSTATE DISORDERS cerous enlargement of the prostate and is common in men over age 40. Symptoms associated with BPH are similar to CROSS-REFERENCE TO RELATED those observed with prostatitis. The etiology of BPH is APPLICATIONS unknown, but may involve hormonal changes associated with aging. With age, testosterone is converted into dihy 0001. Not Applicable droxytestosterone (DHT) at higher levels within the prostate via the enzyme, 5-alpha-reductase. DHT binds to androgen STATEMENT REGARDING FEDERALLY receptors, stimulating growth of the prostate. This growth SPONSORED RESEARCH OR DEVELOPMENT can eventually lead to progressive restriction or obstruction of urine outflow. Incomplete bladder emptying causes Stasis 0002) Not Applicable and predisposes to infection with secondary inflammatory changes in the bladder. Treatment is directed toward reduc REFERENCE TO SEQUENCE LISTING, A ing prostate size, stabilizing renal function, eradicating TABLE, OR A COMPUTER PROGRAM LISTING infection, and discontinuing drugs that may induce obstruc COMPACT DISC APPENDIX tion. The most widely used drug therapy has been systemic 0003) Not Applicable administration of an alpha blocker. Administration of a 5-alpha-reductase inhibitor, which decreases the conversion of testosterone to DHT has also been used. These drugs can FIELD OF THE INVENTION have undesirable side effects of postural hypotension, impo 0004 The present invention relates to compositions and tence, and decreased libido. Surgery is the most definitive methods of using the compositions for the treatment of therapy, and the most widely used Surgical procedure is prostatic disorders in men. More specifically, the invention transurethral resection of the prostate. However, approxi relates to compositions comprising ingredients having anti mately 5 to 10% of patients experience some post Surgical inflammatory, antioxidant, and antitumorigenic activities, problems including impotence and incontinence. and methods of using these compositions to reduce the 0008 Prostate cancer, i.e., adenocarcinoma of the pros incidence of or to treat prostatitis, benign prostatic hyper tate, is the most common malignancy in men greater than 50 plasia (BPH), and adenocarcinoma of the prostate. years in the US. The incidence increases with each decade of life. Prostate cancer is generally slowly progressive and BACKGROUND OF THE INVENTION may cause no symptoms. In late disease, symptoms of bladder outlet obstruction, urethral obstruction, and hema 0005 The prostate is a gland of the male reproductive turia may appear and metastasis to the bone may occur. One system that is located in front of the rectum and just below of the most common means of monitoring for prostate the bladder. The prostate, comprised largely of muscular and cancer is the routine analysis of serum prostate-specific glandular tissue, is wrapped around the urethra, which antigen (PSA). PSA is currently the most sensitive marker carries urine from the bladder out through the tip of the for monitoring prostate cancer progression and response to penis. The primary function of the prostate is to produce therapy. It has been established that increased PSA levels fluid for semen that transports sperm. During the male above the normal range of 0-4 ma be indicative of prostate orgasm, muscular contractions Squeeze the prostate's fluid cancer, although elevated levels have been detected in men propelling sperm and seminal fluid into the urethra; the suffering from prostatitis or BPH. Current traditional treat sperm and seminal fluid leave the penis during ejaculation. ment regimens for prostate cancer range from minimally 0006 Disorders of the prostate are fairly common during invasive treatments, such as watchful waiting, which the aging process and include prostatitis, benign prostatic requires observation of cancer for signs of progression, to hyperplasia (BPH), and adenoma of the prostate, or prostate major Surgery. Treatment regimens such as radiation therapy cancer. Prostatitis, which may or may not be the result of an and cryotherapy eradicate cancer cells but pose risks Such as infection, is generally defined as an inflammation of the incontinence and impotence. Similarly, treatments directed prostate. Symptoms associated with prostatitis are pain, to decreasing testosterone production or blocking the action Voiding symptoms Such as nocturia, frequency and urgency of androgens, i.e., anti-hormone therapy, may result in hot of urination, incomplete voiding, and decreased force and/or flashes or impotence. Radical prostatectomy or Surgical intermittency of the urinary stream, impotence, and infer removal of the prostate, and radiation therapy are the most tility. The cause of non-infection related prostatitis is common treatment methods for prostate carcinoma. How unknown, and therefore, is difficult to treat. Successful ever, radical prostatectomy often results in impotence and treatment of acute bacterial prostatitis and chronic bacterial urinary incontinence. Similarly, radiation therapy has also prostatitis with antibiotics is well established. Inflammatory been known to produce impotence, incontinence, cystitis, chronic pelvic pain syndrome is generally treated with and proctitis. Immunotherapy, i.e., providing agents that antibiotics and anti-inflammatory agents. Alpha blockers can stimulate or boost the immune response is currently under be prescribed to relax muscle tension in the prostate and investigation. Therapeutic modalities can include any one improve urinary flow. However, alpha blockers are expen of or a combination of Surgery, radiotherapy, cryotherapy, sive, need to be taken indefinitely in high doses, may have or hormone therapy depending on the stage of the cancer. significant side effects, and do not cure the underlying 0009 No single cause of prostate cancer has been iden problem or prevent recurrences. Ameliorating the discom tified. However, associations between risk factors, both fort caused by prostatitis with anti-inflammatory agents or nutritional and non-nutritional, and disorders of the prostate hot sitz baths can be beneficial, but these treatments are have been noted. The major known non-nutritional risk temporary and do not cure the disease. factors for prostate cancer are age, race and family history. US 2007/004. 1994 A1 Feb. 22, 2007

With regard to nutritional risk factors, epidemiological stud prostate comprising herbal extracts and zinc. Wheeler (U.S. ies have shown a possible link between high fat diets and Pat. No. 6,197,309) discloses a prostate formula with anti prostate cancer (Thomas, J. A., Nutr. Rev. 57(4):95-103. oxidant, anti-inflammatory, and immunity booster properties 1999). In particular, diets that consist of high levels of red comprising herbal extracts, Zinc, and selenium. meat and dairy products have been correlated with an increase in the risk of advanced prostate cancer. It has also 0013 The immunopotentiating activities and therapeutic been shown that reducing dietary fat intake can reduce effectiveness of polysaccharides obtained from Shiitake circulating levels of testosterone and other hormones that are (lentinus edodes) and maitake (grifola) mushrooms are known to fuel the growth of prostate cancer cells. known in the art. Gorsek (U.S. Pat. No. 6,582,723) discloses 0010 Alterations in the concentration of certain micro an enzymatic extract of Shiitake mushrooms for treating nutrients in blood and prostate tissue have also been noted. cancer by boosting the immune system and helping the For example, a strong association between low serum sele regression of metastases. Nanba et al. (U.S. Pat. No. 5,854. nium levels and an increased incidence of prostate cancer 404) discloses an antitumor Substance with high immuno has been reported. Selenium is essential for glutathione potentiating activity. The Substance is a polysaccharide peroxidase activity, an enzyme that protects cells from isolated from grifola. Keith et al. (U.S. Pat. No. 6,805,866) oxidative damage. Results from in vitro studies indicate disclose a composition of mushrooms that has immunoen growth suppression of prostate cancer cells with addition of hancing properties. These properties have been associated Selenium; this growth Suppression has been correlated with with polysaccharides such as alpha glucans, which are in cell cycle arrest (Wilkinson, S. and Chodak, G. W. J. Clin. high concentrations in Shiitake mushrooms, and beta glu Oncol. 21 (11):2199-2210, 2003). In addition, selenium com cans that are in high concentrations in maitake mushrooms. pounds appear to inhibit tumorigenesis in a number of Tazawa et al. (U.S. Pat. No. 6,616,928) disclose a compo experimental model systems and in human Supplementation sition comprising extracts of maitake mushrooms. The com studies, leading to a reduction in cancer risk. These studies position has immunopotentiating as well as oxygen-Scav Suggest that selenium compounds act as cancer chemopre enging activities that inhibit tumor development. ventive agents. 0014. The medicinal value of cannabis has been known 0011 Pharmaceutical, nutraceutical, and phytoceutical for centuries and there has been no evidence of toxicity compositions comprising selenium in combination with one associated with the medicinal use of cannabis. Cannabis or more ingredients having antiproliferative, anti-inflamma contains over 400 cannabinoid compounds and produces a tory, and immunostimulating properties for the purpose of wide spectrum of central and peripheral effects including maintaining prostate health and treating or preventing pros alterations in cognition and memory, analgesic, anticonvul tate cancer have been described. Newmark et al. (U.S. Pat. sive, and anti-inflammatory activities, and alleviation of No. 6,261,607) disclose a phytoceutical composition com intraocular pressure, nausea, and pain. It has also been prising a number of herbal extracts and selenium. The demonstrated that cannabinoids have direct antitumor activ composition contains phytochemicals having antioxidant ity as well as immune response-associated antitumor activ and anti-inflammatory activities and is used for promoting ity. The antitumor activities involve different physiological prostate health. Fleshner (U.S. Pat. No. 6,670,392) discloses pathways. For example, cannabinoids signal apoptosis by a a nutraceutical composition comprising vitamin E and sele pathway involving cannabinoid receptors, Sustained ceram nium. The composition exhibits enhanced anticarcinogenic ide accumulation, and Raf1/extracellular signal-regulated properties especially for preventing or treating prostate kinase activation (Galve-Roperh, I., et al., Nature Medicine, carcinoma. Waldstreicher et al. (U.S. Pat. No. 6,486,204) 6(3):313-319, 2000). Burstein et al. (U.S. Pat. Nos. 6,448, disclose a pharmaceutical composition comprising selenium 288 and 6,914,072) describe non-psychoactive derivatives and a cyclooxygenase-2 (COX-2) selective inhibiting drug. of delta-9-THC derivatives which are effective in decreasing COX-2 is a key enzyme in the conversion of arachidonic cell proliferation in a number of human cancer cell lines acid to prostaglandins and other eicosanoids and is including the prostate cancer cell lines DU-145 and PC-3. expressed in prostate cancer. The composition is used in treating or preventing prostate cancer. 0015 The psychotropic principle of cannabis is delta-9- tetrahydrocannabinol (delta-9-THC), however, numerous 0012 Clinical studies have also shown lower concentra medicinal properties of cannabis are thought to be associ tions of Zinc in prostate tissue and plasma in persons with ated with the acid metabolites of delta-9-THC, which show prostate cancer compared to controls. Zinc is a component little or no psychoactivity. The physiological effects of the of many physiologically active proteins that play a role in cannabinoids have been attributed to both receptor-mediated regulating apoptosis, transcription, and cellular differentia and non-receptor-mediated activities. Two types of cannab tion. Based on a population-based, case-control study, Kri inoid receptors, CB1 and CB2, have been cloned in humans. stal et al. (Cancer Epidemiology, Biomarkers & Prevention, The central cannabinoid receptor, CB1 is predominantly 8:887-892, 1999) determined that zinc supplementation located in the central nervous system, although CB1 has also reduced the risk of prostate cancer among participants using been detected in the gastrointestinal tract and other periph Zinc daily and therefore exerts a protective effect on prostate eral tissues. The CB2 receptor is predominantly found in the health. Fahim (U.S. Pat. No. 5,071,658) discloses an immune system. These receptors are members of the G-pro improvement in prostatitis with intraprostatic injections of tein-coupled receptor superfamily (Pertwee, R. G., Pharma Zinc at a concentration Sufficient to increase the amount of col. Ther. 74(2):129-180, 1997). CB1 and CB2 receptors prostatic antibacterial factor and to inhibit the rate of pros have been demonstrated in prostate tissue. Recently, Ruiz tatic growth. Perez (U.S. Pat. No. 5,543,146) discloses a Llorente et al. (The Prostate, 54.95-102, 2003) have pro phytoceutical dietary Supplement for alleviating the Symp vided evidence that the CB1 receptor is functionally active toms associated with enlargement and inflammation of the in the human prostate gland. US 2007/004. 1994 A1 Feb. 22, 2007

0016 Several reports in the literature demonstrate poten BRIEF SUMMARY OF THE INVENTION tial antitumorigenic effects of cannabinoids on prostate tissue and cells via different physiological pathways. For 0019. The primary object o the invention is to provide a example, Purohit et al. (Endocrinology, 107:848-850, 1980) composition which is effective in treating prostate disorders. have established that delta-9-THC inhibits specific binding 0020. It is also an object of the invention to provide a of dihydroxytestosterone to the androgen receptor in the composition comprising all natural ingredients with no prostate gland, potentially regulating the serum levels of adverse side effects, the composition and which is effective many sex hormones, thereby having an indirect antitumori in treating prostate disorders. genic effect. Melck et al. (Endocrinology, 141:118-126, 2000) have shown that endocannabinoids, i.e. naturally 0021. It is further an object of the invention to provide a occurring cannabinoids, inhibit prolactin-induced prolifera method of treating prostate disorders comprising adminis tion in the prostate cell line, DU-145, by inhibiting expres tering to a patient in need thereof a composition which is sion of prolactin receptors via a CB1-dependent mechanism. effective in treating prostate disorders. Ruiz et al. (FEBS Letters, 458:400-404,1999) have shown 0022. In a preferred embodiment, the composition com that delta-9-THC causes apoptosis in the prostate cell line, prises a therapeutically effective amount of enhanced can PC-3. The apoptotic effect was similar to that apoptotic nabis. Enhanced cannabis is defined as a selenium- and effect typically associated with ceramide accumulation. Zinc-enriched multigenerational cannabis indicaxcannabis Ceramide has been implicated as an important second mes ruderillis hybrid plant. senger regulating cell death. In prostate cells, ceramide has 0023. In a second preferred embodiment, the composition been shown to mediate apoptosis. comprises a therapeutically effective amount of enhanced 0017. The analgesic and anti-inflammatory properties of cannabis, Shiitake mushrooms, and maitake mushrooms. delta-9-THC may be due to its acid metabolites (Burstein, S. 0024. In a preferred embodiment, the method of treating H., Pharmacol. Ther. 82(1): 87-96, 1999). Acid metabolites prostate disorders comprises administering to a patient in may result in an inhibition of eicosanoid synthesis; need thereof a therapeutically effective amount of enhanced eicosanoids are mediators of inflammation. It has been postulated that the analgesic and anti-inflammatory proper cannabis. The mode of administration can be by inhalation. ties are due to cannabinoid acids impacting on the arachi 0025. In a second preferred embodiment, the method of donic acid cascade by either causing an accumulation of free treating prostate disorders comprises administering to a arachidonic acid or by inhibiting the synthesis of COX-2. patient in need thereof a therapeutically effective amount of COX-2 products are associated with inflammation. As a a composition comprising and aqueous extract of enhanced potential analgesic and anti-inflammatory therapeutic, it is cannabis, Shiitake mushrooms, and maitake mushrooms. of interest that chronic users of cannabis who are exposed to The method comprises administration of the composition to high blood levels of the delta-9-THC metabolite, delta-8- mucosal membranes of the urethra or to mucosal membranes THC-11-oic acid, appear to be free from non-steroidal of the rectum. anti-inflammatory drug-type toxicity. This may be due in 0026. In another preferred embodiment, the method com part to a selective inhibition of COX-2. prises administration of a composition comprising an equal 0018. The prior art indicates that pharmaceuticals, phy amount of dried enhanced cannabis, dried Shiitake mush tochemicals, and nutraceuticals are available for treating rooms, and dried maitake mushrooms. The composition is disorders of the prostate by providing antioxidant activity, encapsulated in a cellulose capsule and administered orally. anti-inflammatory activity, and/or antitumorigenic activity. 0027. The objects of the invention have been obtained by However, it is a concern that pharmaceuticals are expensive, the inventor's discovery that systemic administration of the have undesirable side effects, and generally require systemic compositions by oral or inhalation means, or by local application. It is a further concern that phytochemicals or administration of the composition to mucosal membranes of extracts obtained from various plant sources can potentially the urethra or rectum, is effective in treating prostate disor contain toxins, may not be standardized, or may interact ders. with other medications. Therefore, it would be advantageous to provide natural compositions for treatment of prostate 0028. It is to be understood that the foregoing description disorders that lack toxic properties and that contain desirable is exemplary and explanatory only and not to be viewed as therapeutically effective activities such as anti-inflamma being restrictive of the invention as claimed. tory, antioxidant, as well as antitumorigenic activities. In this regard, extracts of cannabis plant material have been estab BRIEF DESCRIPTION OF THE SEVERAL lished to be non-toxic, and to have anti-inflammatory, anti VIEWS OF THE DRAWINGS oxidant, and antitumorigenic properties in prostate tissue. 0029) Not Applicable Given the lack of toxicity of cannabinoids and the ability of the cannabinoids to protect prostate health by a myriad of DETAILED DESCRIPTION OF THE distinct receptor-mediated and receptor-independent path INVENTION ways by providing antioxidant protection, altering the con version of testosterone to dihydroxytestosterone, inhibiting 0030 The present invention provides compositions and the binding of dihydroxytestosterone to androgen receptors, methods for the treatment of prostate disorders in patients in inducing apoptosis, and decreasing cellular proliferation, need thereof. As used herein, “prostate disorders' refers to compositions containing cannabis extracts provide a thera prostatitis, benign prostatic hypertrophy, and prostate can peutically effective means of treating prostate disorders in cer. “Therapeutically effective amount of the composi patients in need thereof. tion(s) includes but is not limited to an amount of the US 2007/004. 1994 A1 Feb. 22, 2007 composition which is effective in treating prostate disorders 0035. The aqueous extract of the present invention may by alleviating pain and Voiding symptoms, decreasing be administered to the mucosal membranes of the urethra by inflammation and prostate size, reducing cellular prolifera insertion of a small gauge pediatric catheter. Gentle inflation tion in prostate tissue, and/or reducing PSA levels to within of the distal bulb of the catheter affects occlusion of the the normal range of 0-4. urethra and affords a direct route via the central channel of the catheter to the urethra. Infusion of the urethra with the 0031. The enhanced cannabis plant is a multigenerational therapeutic Solution is readily performed by retrograde clone developed from an initial crossing of two subspecies injection of the solution through the tip of the catheter. of cannabis, i.e., cannabis indica and cannabis ruderillis Contact is maintained with the urethra by clamping the and Subsequent clonal propagation. Cannabis indica natu catheter to prevent the therapeutic solution from refluxing rally synthesizes high levels of delta-9-THC and is relatively through the bore of the catheter and by the inflated catheter short in height. Cannabis ruderillis contains trace levels of bulb preventing the solution from draining down the urethra. delta-9-THC, is relatively short in height, and has a fast The sphincter of the bladder prevents spillage of the solution growth period. The advantageous properties of the multi into the bladder. The catheter bulb is deflated at the end of generational clonal cross of cannabis indicaxcannabis rud the treatment period and the catheter is removed. Alterna erillis are that the plant produces high concentrations of tively, the Solution can be applied to the prostate via mucosal delta-9-THC, and the plant takes less time to mature. The tissue of the rectum by use of an enema bag or Squeeze short stature of the plant enables cultivation indoors allow applicator inserted into the rectum. Delivery of a recom ing for growth in a controlled environment with respect to mended dosage of 8 fluid ounces of the aqueous solution to purified air and water, temperature, and lighting, thereby the prostate via the mucosal tissues of the urethra or rectum allowing natural standardization of the types and concen is accomplished twice a day, once in the morning and once trations of therapeutically effective cannabinoids in the in the evening. For prostatitis or BPH, treatment continues enhanced cannabis plant and compositions made therefrom. until the patient is asymptomatic. For prostate cancer, treat 0032. It has been established that selenium and Zinc are ment is continued until the cancer is no longer detectable as effective nutraceuticals in maintaining prostate health. As determined by means well known in the art. cannabis plants are known to be accumulators of trace 003.6 Local administration of the aqueous composition metals, it is advantageous to Supplement the plants, particu can be combined with Systemic administration of a compo larly at the flowering phase of growth, with an application of sition containing dried enhanced cannabis. Systemic admin a mixture of sea kelp and sea bird guano; this mixture istration is via inhalation of approximately 0.3 grams of contains organically chelated selenium and zinc. The plants dried enhanced cannabis through a water-filled Smoking are capable of absorbing and accumulating these minerals device 3 times daily, preferably before meals. For prostatitis during this growth period. A Subsequent augmentation with or BPH, treatment continues until the patient is asymptom a solution containing chelated Zinc during the stage of atic. For prostate cancer, treatment is continued until the metabolic maturation allows for maximal accumulation of cancer is no longer detectable as determined by means well Zinc. At harvest, buds are removed and the stems and leaves known in the art. and dried in the dark for 2 days, sealed in airtight bags and fresh frozen to keep the selenium- and zinc-enriched Can 0037. A second composition of the invention is formu nabis indicaxcannabis ruderillis plant material fresh indefi lated for oral administration. The composition contains three nitely. components, dried enhanced cannabis, dried Shiitake mush rooms and dried maitake mushrooms. Each component is 0033 Methods of interbreeding subspecies of cannabis finely ground and a mixture containing approximately 0.3 plants for clonal propagation and methods of indoor culti grams of each component is added to a cellulose capsule. Vation are well known in the art (see, for example, Marijuana One cellulose capsule is taken in the morning and once in the Grower's Guide, Deluxe Edition by Mel Frank, Red Eye evening for maximum absorption. For prostatitis or BPH, Press, L.A., Calif. and Indoor Marijuana Horticulture: The treatment continues until the patient is asymptomatic. For Medical, Legal, Cultivation Encyclopedia for 2001 and prostate cancer, treatment is continued until the cancer is no Beyond by Jorge Cervantes). longer detectable as determined by means well known in the 0034. In a preferred embodiment, the composition of the art. present invention comprises an aqueous extract of leaves 0038 All publications and patent documents referenced and female buds of an enhanced cannabis plant. One gram in this application are incorporated herein by reference in of dried enhanced cannabis is finely chopped and placed in their entirety. one quart of water which has been purified by a pre-filter, 0039 Those skilled in the art will recognize, or be able to carbon filter, and reverse osmosis filter. One shiitake mush ascertain using no more than routine experimentation, many room (lentinula edodes) and approximately an equal amount equivalents to the specific embodiments of the invention by weight of maitake mushroom (grifola frondosa) are specifically described herein. Such equivalents are intended chopped, and the chopped mushrooms are added to the quart to be encompassed in the scope of the following claims. of purified water. The combination of finely chopped dried cannabis and chopped mushrooms forms a suspension in the 1. A composition for treating prostatitis, benign prostatic purified water. The Suspension is heated under a light Source hypertrophy, or prostate cancer, the composition comprising a temperature ranging from 95° F to 105 F. for a period of a therapeutically effective amount of an aqueous extract of approximately one to two weeks. The plant and fungal finely chopped dried selenium- and zinc-enhanced cannabis materials are strained from the Solution thereby obtaining a (cannabis indicaxcannabis ruderillis), chopped shiitake particulate-free aqueous extract which is suitable for admin mushrooms (lentinula edodes), and chopped maitake mush istration. rooms (grifola frondosa). US 2007/004. 1994 A1 Feb. 22, 2007

2. The composition of claim 1 wherein said aqueous 9. The method of claim 8, wherein the composition is an extract is produced by aqueous extract of finely chopped dried selenium- and a) mixing in one quart of purified water one gram of finely Zinc-enhanced cannabis (cannabis indicaxcannabis ruder chopped dried selenium- and zinc-enhanced cannabis illis), chopped shiitake mushrooms (lentinula edodes), and (cannabis indicaxcannabis ruderillis), one chopped chopped maitake mushrooms (grifola frondosa). shiitake mushroom (lentinula edodes), and chopped 10. A method of treating prostatitis, benign prostatic maitake mushrooms (grifola frondosa) in an amount hypertrophy, or prostate cancer in a patient in need thereof, equivalent by weight to the chopped shiitake mush said method comprising administering a therapeutically room (lentinula edodes) to form a suspension; effective amount of the composition of claim 2. b) heating the Suspension at a temperature range of 11. The method of claim 10, wherein the therapeutically approximately 95° F to 105° F for a period of one to effective amount is 8 fluid ounces. two weeks; and 12. The method of claim 11, wherein the composition is c) straining the heated Suspension thereby obtaining a administered twice daily. particulate-free aqueous extract. 13. The method of claim 12, wherein the composition is 3. A composition for treating prostatitis, benign prostatic administered to the mucosal membranes of the urethra by hypertrophy, or prostate cancer, the composition comprising way of a pediatric catheter. a therapeutically effective amount of a mixture of three 14. The method of claim 12, wherein the composition is components, wherein the three components are finely administered to the mucosal membranes of the rectum by ground dried selenium- and zinc-enhanced cannabis (can way of an enema or Squeeze applicator. nabis indicaxcannabis ruderillis, finely ground dried shii take mushrooms (lentinula edodes), and finely ground 15. A method of treating prostatitis, benign prostatic maitake mushrooms (grifola frondosa). hypertrophy, or prostate cancer in a patient in need thereof, 4. The composition of claim 3 wherein the three compo said method comprising administering the composition of nents of the mixture are present in equal amounts. claim 5. 5. The composition of claim 4, wherein 0.3 grams of each 16. The method of claim 15, wherein the composition is component is present in the mixture. administered twice daily. 6. The composition of claim 4 wherein the composition is 17. A method of treating prostatitis, benign prostatic packaged in a cellulose capsule suitable for oral adminis tration. hypertrophy, or prostate cancer in a patient in need thereof, 7. The composition of claim 5 wherein the composition is said method comprising administration of a therapeutically packaged in a cellulose capsule for oral administration. effective amount of a composition comprising dried sele 8. A method of treating prostatitis, benign prostatic hyper nium- and zinc-enhanced cannabis (cannabis indicaxcan trophy, or prostate cancer in a patient in need thereof, said nabis ruderillis). method comprising administering a therapeutically effective 18. The method of claim 17, wherein the composition is amount of a composition comprising selenium- and zinc administered by inhalation through a water-filled Smoking enhanced cannabis (cannabis indicaxcannabis ruderillis), device. Shiitake mushrooms (lentinula edodes), and maitake mush rooms (grifola frondosa).