Treatment of Prostate Cancer With Firmagon®

Prostate Cancer Clinical Trial

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®

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01710098
• Other study ID #: UCM12-01
• Status: Completed
• Start date: June 2012
• Est. completion date: September 24, 2015

Study information

• Verified date: April 2020
• Source: United Clinic Management GmbH
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 100
• Est. completion date: September 24, 2015
• Est. primary completion date: June 2014
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years to 95 Years

Eligibility

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

Related Conditions & MeSH terms

• Prostate Cancer
• Prostatic Neoplasms

Intervention

Drug:
• Degarelix
subcutaneous injection

Locations

Country	Name	City	State
Germany	UCM GmbH	Planegg	Bavaria

Sponsors (1)

Lead Sponsor	Collaborator
United Clinic Management GmbH

Country where clinical trial is conducted

Germany, 

References & Publications (7)

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

Klotz L, Boccon-Gibod L, Shore ND, Andreou C, Persson BE, Cantor P, Jensen JK, Olesen TK, Schröder 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. — View 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. — View Citation

Morote J, Orsola A, Planas J, Trilla E, Raventós CX, Cecchini L, Catalán 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. Epub 2007 Aug 14. — View 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. — View 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. — View 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. Review. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	PSA-/Testosterone Level		12 months
Secondary	S3 Guideline	Percentage of patients who have been treated in accordance with the grade A recommendations of the S3 guideline for treatment of prostate cancer	12 months
Secondary	Anxiety	Anxiety score	12 Months