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Trial #NCT01710098
Prostate Cancer Clinical Trials

Treatment of Prostate Cancer With Firmagon®


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 ID: UCM12-01; Source: United Clinic Management GmbH
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Definitions
Interventional trials
Determine whether experimental treatments or new ways of using known therapies are safe and effective under controlled environments.
Observational trials
Address health issues in large groups of people or populations in natural settings.
Recruiting
Participants are currently being recruited and enrolled.
Active, not recruiting
Study is ongoing (i.e., patients are being treated or examined), but enrollment has completed.
Not yet recruiting
Participants are not yet being recruited or enrolled.
Enrolling by invitation
Participants are being (or will be) selected from a predetermined population.
Completed
The study has concluded normally; participants are no longer being examined or treated (i.e., last patient's last visit has occurred).
Withdrawn
Study halted prematurely, prior to enrollment of first participant.
Suspended
Recruiting or enrolling participants has halted prematurely but potentially will resume.
Terminated
Recruiting or enrolling participants has halted prematurely and will not resume; participants are no longer being examined or treated.
Status Recruiting
Country Germany
Study type Observational
Enrollment 100
Start date June 2012
Completion date June 2014
Phase N/A
Sponsor United Clinic Management GmbH
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:
Gender: Male
Age: 18 Years - 95 Years
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
Outcome:
Primary outcome
  • PSA-/Testosterone Level
    Time frame: 12 months
Secondary outcome
  • Anxiety
    Anxiety score
    Time frame: 12 Months
  • Pain
    analog visual painscala
    Time frame: 12 Months
  • Quality of Life
    QLQ-PR 25
    Time frame: 12 months
  • 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
    Time frame: 12 months
Contacts:
  • Leopold Durner, MD; UCM GmbH (Principal Investigator)
  • Leopold Durner, MD;
    Phone: +49-89-85693-0
  • Roland Lang, MD;
    Phone: +49-89-85693-0
Location Country Status
UCM GmbH Planegg, Bavaria Germany Recruiting
Sponsors:
  • United Clinic Management GmbH - (Lead Sponsor)

Related trials: References:
  • 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.
  • 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. 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.
  • 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.
Terms
  • Quality of Life
  • S3-Adherence
  • testosterone
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