Degarelix: A New Treatment for Advanced Prostate Cancer

The second leading cause of death among men in the United States is prostate cancer. "About one man in six will be diagnosed with prostate cancer during his lifetime, and one in 35 will die of this disease." 1 Estimated in 2008 (United States), 186,320 diagnosis prostate cancer cases and 28,660 related deaths. 6 In December 2008, the Food and Drug Administration approved injectable drug Degarelix for advanced prostate cancer, effectively better than standard treatment, stopping the production of testosterone linked to prostate cancer. 1

Prostate is a gland (Organ that produces a secretion for use elsewhere in the body 2) about the size of a walnut. "It is located in front of the rectum and just below the bladder." The gland functions to produce fluid known as semen (seminal fluid 3 ): Delivers sperm (40 to 600 million 5) during the male orgasm or ejaculation. 4 Also, prostate gland functions to press directly against the part of the urethra (Passage through which urine drains from the bladder to exit from the penis.) for urination. 7

The onset of cancer (malignancy) in the prostate shows few or any symptoms: Urination becomes difficult, diminishes or is obstructed because the cancerous prostate presses on the urethra, burning sensation during urination or blood observed in the urine. Often the diagnosis of prostate cancer is apparent after metastasize or spread to other parts of the body during the advanced stage of prostate cancer. Recommended men at the age of forty, undergo a yearly screening for prostate cancer: Examination for prostate cancer digital rectal examination (Physician feels the prostate gland for any irregularities including a lump or hardness with a gloved index finger), and prostate specific antigen (PSA) blood test (High level of PSA above 10 nanograms per milliliter of blood considered abnormal, suggesting the possibility of prostate cancer, and under four nanogram per milliliter generally considered normal.). 8

When the diagnosis for prostate cancer is made sooner before metastasize, outcome of treatment is greatly improved. Risk factors for developing prostate cancer include genetics (heredity), advanced age ("As a matter of fact, some studies have suggested that among men over 80, between 50 and 80% of them may have prostate cancer."), exposure to toxins, chemicals and industrial products. Significantly important growth of prostate cancer and normal prostate tissue is linked to the male hormone testosterone. 9

In December 2008, Food and Drug Administration approved Ferring Pharmaceuticals ("Ferring Pharmaceuticals headquartered in Switzerland with U.S. offices in Parsippany, N.J." 12) injectable Degarelix (Trade name is still under review 1) treat patients with advanced prostate cancer. The drug is type of gonadotropin releasing hormone (GnRH) receptor inhibitor: Suppresses testosterone production slows the growth and progression of prostate cancer. During clinical studies, observed degarelix decreased testosterone immediately compared to leuprolide (drug currently used to treat advanced prostate cancer) and other GnRH drugs, which initially caused testosterone level to increase before decreasing. 10 Prior to the development of GnRH drugs in the mid - 1980's, surgical castration was the only option to treat advanced prostate cancer by reducing testosterone. When degarelix was administered in clinical trial, prostate specific antigen (PSA) significantly decreased: From 64 percent within two weeks after administration to 95 percent after three months. During phase three study, prostate cancer treatment recipients received 240 mg of degarelix for one month with monthly maintenance doses of 80 mg. 1 In the first quarter of 2009, Degarelix is expected to be available for sale.11

"On December 18 (2008), the Committee for Medical Products for Human Use (CHMPP), part of the European Medicines Agency (EMEA), recommended granting a marketing authorization for the degarelix in Europe.". Other global markets are awaiting approval for the sale and distribution of degarelix. 1

When degaretix was administered most frequent adverse reactions included: Pain, redness and swelling in the injection site, increased weight, hot flashes, fatigue, and increase in some liver enzymes. 10

References:

1.) FDA Approve Ferring Pharmaceuticals Degarelix (Generic Name) for Treatment of Advanced Prostate Cancer -

http://www.genengnews.com/news/bnitem.aspx?name=47588388

2.) gland - http://www.answers.com/topic/gland

3.) Semen - http://en.wikipedia.org/wiki/Semen

4.) About the Prostate - http://www.prostate.com/prostate/

5.) Semen - http://menshealth.about.com/cs/stds/a/about_semen.htm

6.) Prostate Cancer - http://www.cancer.gov/cancertopics/types/prostate

7.) Prostate Cancer -

http://www.medicinenet.com/prostate_cancer/article.htm

8.) Prostate Cancer (cont.) - http://www.medicinenet.com/prostate_cancer/page3.htm

9.) Prostate Cancer (cont.) - http://www.medicinenet.com/prostate_cancer/page2.htm

10.) FDA approves injecable drug degarelix for advanced prostate cancer - http://www.news-medical.net/?id=44511

11.) FDA clears new prostate cancer treatment - http://www.fox59.com/pages/landing/?blockID=172447&feedID=1295

12.) FDA approves new prostate cancer drug - http://www.sfgate.com/cgi-bin/article.cgi?f=/n/a/2008/12/29/financial/f100347S00.DTL&feed=rss.business