Treatment of Prostate Cancer With Firmagon®
Sponsor
United Clinic Management GmbH (Industry)
Overall Status
Completed
CT.gov ID
NCT01710098
Collaborator
(none)
100
1
39.8
2.5
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
Study Design
Study Type:
Observational
Actual Enrollment
:
100 participants
Observational Model:
Case-Control
Time Perspective:
Prospective
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 Start Date
:
Jun 1, 2012
Actual Primary Completion Date
:
Jun 1, 2014
Actual Study Completion Date
:
Sep 24, 2015
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Degarelix adult male patients with advanced hormone dependent prostate cancer who receive 240 mg as a start dose and then monthly 80mg Firmagon® for one year |
Drug: Degarelix
subcutaneous injection
Other Names:
|
Outcome Measures
Primary Outcome Measures
- PSA-/Testosterone Level [12 months]
Secondary Outcome Measures
- S3 Guideline [12 months]
Percentage of patients who have been treated in accordance with the grade A recommendations of the S3 guideline for treatment of prostate cancer
- Anxiety [12 Months]
Anxiety score
Eligibility Criteria
Criteria
Ages Eligible for Study:
18 Years
to 95 Years
Sexes Eligible for Study:
Male
Accepts Healthy Volunteers:
No
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
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | UCM GmbH | Planegg | Bavaria | Germany | 82152 |
Sponsors and Collaborators
- United Clinic Management GmbH
Investigators
- Principal Investigator: Leopold Durner, MD, UCM GmbH
Study Documents (Full-Text)
None provided.More Information
Publications
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
Responsible Party:
Karin Buchsteiner,
Head of Study Group,
United Clinic Management GmbH
ClinicalTrials.gov Identifier:
NCT01710098
Other Study ID Numbers:
- UCM12-01
First Posted:
Oct 18, 2012
Last Update Posted:
Apr 13, 2020
Last Verified:
Apr 1, 2020
Keywords provided by Karin Buchsteiner,
Head of Study Group,
United Clinic Management GmbH
Additional relevant MeSH terms: