Two new studies presented at the XXVII Congress annual of the European Association of Urology (EAU) show that degarelix, to reduce the prostatic volume in patients with advanced hormonodependiente prostate cancer, is not less than the set

-prostate cancer depends on testosterone for growth and to reduce levels of testosterone slows down the growth of cancer cells

-Degarelix has unique chemical characteristics and mechanism of action novel, unlike conventional hormonal therapies; rapidly reduces testosterone levels within a period of three days without using an antiandrogen to avoid the flare

Madrid, March 2012.- two new studies presented at the XXVII Congress annual of the European Association of Urology (EAU) which was held in Paris have shown that degarelixa blocker of the recipients of the releasing hormone gonadotropin (GnRH) to reduce total prostatic volume in men with advanced hormonodependiente prostate cancer, is similar to the combination of goserelin (a GnRH agonist) with bicalutamida. Degarelix, marketed under the name of Firmagon ® offers also a better control of the lower urinary tract symptoms (LOOTZ)(1-2). The LOOTZ can be frequency, urgency and urinary difficulty, and affect negatively the quality of life (3-4) for men with prostate cancer.

Prostate cancer is the most common form of male cancer in the Western world (5) and the second leading cause of death from cancer in men in some countries (6). Each year are diagnosed in Europe about 300,000 new cases of prostate cancer. At the global level, this figure rises to 670,000 new cases (7).

The Phase IIIb CS30 trial evaluated the use of the molecule as neoadjuvant hormone therapy in men with moderate or high risk of prostate cancer. A review recently published shows that deprivation therapy androgen (TPA) prior to radiotherapy, can improve specific mortality of the disease and overall survival, compared with radiotherapy alone in men with high-risk localized or locally advanced prostate cancer (8). After 3 months the CS30 trial results showed degarelix is not inferior to goserelin and bicalutamida in terms of the reduction in prostate volume (average prostate volume percentage change: – 36.0% with degarelix – 35.3% with goserelin and bicalutamida). In addition, demonstrated greater relief the LOOTZ goserelin and bicalutamida. The overall incidence of adverse events (AA) was similar in both groups; the most common AA were the anticipated consequences of the TPA (1).

The Phase IIIb CS31 trial assessed their ability to reduce the volume of prostate in a wide variety of patients. Once again, the results after 3 months of treatment showed that achieved the prostatic volume reduction was similar to the combination of goserelin and bicalutamida. He also had a positive effect significantly more pronounced in symptomatic patients (2) LOOTZ.

According to Dr. Alfredo Rodríguez Antolín, responsible for the unit of prostate of the service of Urology of the H. October 12 and researcher of this molecule in Spain, already knew data showing parameters of effectiveness equivalent Degarelix and other analogues of LH-RH traditionally employed in the management of prostate cancer advanced by urologists ”.

The objective of the TPA is quickly reduce testosterone levels in any sustained way to slow the growth of cancer cells. The use of GnRH agonists is associated with a rapid initial release of androgens (surge), delay the start of the TPA and can lead to complications (9). To avoid these limitations, GnRH agonists should be administered with an antiandrogen at the beginning of treatment (10).

On the other hand, Firmagon ® is a blocker of receptors for GnRH that, unlike the GnRH agonists, quickly blocks the production of testosterone, which prevents sudden increase initial of testosterone and thus reduces the need for concomitant antiandrógenos. In the study of registration that shows that it is not less than leuprorelina, reduced testosterone to an effective level of very quickly by more than 97% of the pacientes(12-13). Additional analyses of the same fundamental study showed that it also reduced the risk of progression of prostate-specific antigen (PSA) or death in 34% (CR = 0,664 – 95% CI, 0, 385-1, 146). Further studies are needed to confirm these findings (13). In a study of expansion of the fundamental study, degarelix continued controlling PSA at age three (14). It is desirable to delay the progression of the PSA, that you can postpone the need for second-line therapies that include chemotherapy (15). New data suggest now that it offers prostate cancer patients greater relief the LOOTZ.

Bibliography

1 Mason M, et to the. Degarelix as neoadjuvant hormone therapy in patients with prostate cancer: Results from a phase IIIb randomised, comparative trial versus goserelin plus bicalutamide. Abstract presented at the 27th EAU Congress, 2012

2. Axcrona k., et to the. Androgen deprivation therapy for volume reduction, LOOTZ relief and quality of life improvement in men with prostate cancer: Degarelix versus goserelin plus bicalutamide. Abstract presented at the 27th EAU Congress, 2012.

3 Welch G, et to the. Medicine. 2002 Feb; 59 (2): 245-50.

4 Monsoon JA, et to the. Arch Esp Ural. 2005 Mar; 58 (2): 109-13.

5. University of Iowa Hospitals and Clinics. available here [Accessed 15 Feb 2012]

6. American Cancer Society. available here [Accessed 15 Feb 2012]

7. Cancer Research UK. Available here

8. Payne, H & Mason, M. British Journal of Cancer. 2011; 105: 1628 – 1634. [Accessed 15 Feb 2012]

9 Sugiono M et to Prostate Cancer Prostatic Dis. 2005; 8: 91-4.

10. M Gittelman et to the; Degarelix Study Group. J Ural. 2008; 180: 1986-92.

11. Klotz L, et to the. BJU Int 2008; 102: 1531 – 1538.

12. Firmagon (degarelix). Summary of Product Characteristics. July 2010

13. B Tombal, et to the. EUR Ural 2010; 57: 836-42

14. ED Crawford, et to the. The Journal of medicine September 2011; 186 (3): 889-897

15. Mahon KL, et to the. Endocr Relat Cancer 2011; 18:R103 – R123.

16. Van Poppel H et to the. Abstract (23) Euro Ural Suppl. 2007; 6 (2): 28

17. [Accessed 25 May 2010]