Trial document





This study has been imported from ClinicalTrials.gov without additional data checks.
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  DRKS00006387

Trial Description

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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®

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Trial Acronym

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URL of the Trial

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Brief Summary in Lay Language

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.

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Brief Summary in Scientific Language

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Organizational Data

  •   DRKS00006387
  •   2014/11/17
  •   2012/10/10
  •   no
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Secondary IDs

  •   NCT01710098  (ClinicalTrials.gov)
  •   UCM12-01  (United Clinic Management GmbH)
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Health Condition or Problem studied

  •   Prostate Cancer
  •   C61 -  Malignant neoplasm of prostate
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Interventions/Observational Groups

  •   Drug: Degarelix
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Characteristics

  •   Non-interventional
  •   Observational study
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  •   N/A
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Primary Outcome

- PSA-/Testosterone Level; time frame: 12 months

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Secondary Outcome

- S3 Guideline; time frame: 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
- Quality of Life; time frame: 12 months; QLQ-PR 25
- Anxiety; time frame: 12 Months; Anxiety score
- Pain; time frame: 12 Months; analog visual painscala

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

  •  
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Recruitment

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  •   2012/06/30
  •   100
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Inclusion Criteria

  •   Male
  •   18   Years
  •   95   Years
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Additional 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

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Exclusion Criteria

- contraindication for Degarelix

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Addresses

  • start of 1:1-Block address primary-sponsor
    • United Clinic Management GmbH
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    • UCM GmbH
    • Leopold Durner, MD 
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    • Leopold Durner, MD 
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    •   +49-89-85693-0
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    •   Durner at ukmp.de
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Sources of Monetary or Material Support

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    • Bitte wenden Sie sich an den Sponsor / Please refer to primary sponsor
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Status

  •   Recruiting ongoing
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Trial Publications, Results and other Documents

  •   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.; 2122011
  •   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.; 17698136
  •   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.; 16697805
  •   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.; 19035858
  •   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.; 19747358
  •   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.; 20961245
  •   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
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The parameters in ClinicalTrials.gov and DRKS are not identical. Therefore the data import from ClinicalTrials.gov required adjustments. For full details please see the DRKS FAQs .
  •   5
  •   2016/01/14


* This entry means the parameter is not applicable or has not been set.