Clinical trial NCT01710098: Treatment of Prostate Cancer With Firmagon®
Official title: Effectiveness and Safety as Well as Adherence of the "S3 Guidelines for the Treatment of Prostate Cancer" in the Treatment of Patients of Patients With Firmagon®
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Prostate Cancer
Keywords: testosterone
S3-Adherence
Quality of Life
Lead sponsor: United Clinic Management GmbH
Sponsor class: INDUSTRY
First posted: 2012-10-18
Enrollment: 100
Sex: MALE
Minimum age (years): 18
Maximum age (years): 95
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: adult male patients of outpatient urological medical practice

Brief summary: How are testosterone levels of patients with prostate cancer under treatment with Firmagon® changing.

Former studies showed a quick fall of testosterone levels after start of therapy with Firmagon® and a quick recovery when therapy is stopped. The investigators want to prove this in a normal outpatient urologist setting. Furthermore data is collected to prove the adherence to the German S3-Guideline for the treatment of prostate cancer.


Eligibility criteria: Inclusion Criteria:

* advanced hormone-dependent prostate cancer with no other previous hormone therapy for whom - irrespectively of this NIS -the use of Firmagon® is intended

Exclusion Criteria:

* contraindication for Degarelix

Primary outcomes:
measure: PSA-/Testosterone Level
timeFrame: 12 months
Secondary outcomes:
measure: S3 Guideline
timeFrame: 12 months
measure: Anxiety
timeFrame: 12 Months
Other outcomes:
Locations:
city: Planegg
country: Germany
facility: UCM GmbH
state: Bavaria
Study officials:
affiliation: UCM GmbH
name: Leopold Durner, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Thompson IM, Zeidman EJ, Rodriguez FR. Sudden death due to disease flare with luteinizing hormone-releasing hormone agonist therapy for carcinoma of the prostate. J Urol. 1990 Dec;144(6):1479-80. doi: 10.1016/s0022-5347(17)39774-4.
citation: Klotz L, Boccon-Gibod L, Shore ND, Andreou C, Persson BE, Cantor P, Jensen JK, Olesen TK, Schroder FH. The efficacy and safety of degarelix: a 12-month, comparative, randomized, open-label, parallel-group phase III study in patients with prostate cancer. BJU Int. 2008 Dec;102(11):1531-8. doi: 10.1111/j.1464-410X.2008.08183.x.
citation: Morote J, Orsola A, Planas J, Trilla E, Raventos CX, Cecchini L, Catalan R. Redefining clinically significant castration levels in patients with prostate cancer receiving continuous androgen deprivation therapy. J Urol. 2007 Oct;178(4 Pt 1):1290-5. doi: 10.1016/j.juro.2007.05.129. Epub 2007 Aug 14.
citation: Perachino M, Cavalli V, Bravi F. Testosterone levels in patients with metastatic prostate cancer treated with luteinizing hormone-releasing hormone therapy: prognostic significance? BJU Int. 2010 Mar;105(5):648-51. doi: 10.1111/j.1464-410X.2009.08814.x. Epub 2009 Aug 28.
citation: Mariani S, Salvatori L, Basciani S, Arizzi M, Franco G, Petrangeli E, Spera G, Gnessi L. Expression and cellular localization of follicle-stimulating hormone receptor in normal human prostate, benign prostatic hyperplasia and prostate cancer. J Urol. 2006 Jun;175(6):2072-7; discussion 2077. doi: 10.1016/S0022-5347(06)00273-4.
citation: Radu A, Pichon C, Camparo P, Antoine M, Allory Y, Couvelard A, Fromont G, Hai MT, Ghinea N. Expression of follicle-stimulating hormone receptor in tumor blood vessels. N Engl J Med. 2010 Oct 21;363(17):1621-30. doi: 10.1056/NEJMoa1001283.
citation: Heidenreich A., Epplen R., Thüer D., Van Erps T., D.P., EURO Prostate Center. EAU guideline on advanced prostate cancer: Compliance among urologists conderning androgen deprivation therapy