Trial document





This study has been imported from ClinicalTrials.gov without additional data checks.
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  DRKS00004030

Trial Description

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Title

An Open-label, Randomised, Multi-centre, Parallel Group Comparison of the Efficacy and Safety of Degarelix at Six Different Dosing Regimens in Patients With Prostate Cancer Treated for 12 Months

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Trial Acronym

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URL of the Trial

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Brief Summary in Lay Language

The purpose of the trial was to evaluate the safety and efficacy of degarelix when comparing
six different doses. The patients participating in the trial were treated with degarelix
every month for a year. During the treatment the patients had to visit the clinic for
investigations. Blood samples for testosterone, dihydrotestosterone, luteinizing hormone,
follicle stimulating hormone, and Prostate Specific Antigen were taken and analysed
throughout the trial.

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Brief Summary in Scientific Language

Degarelix was not FDA regulated at the time of the trial. After completion of the trial
degarelix has been approved by the FDA and is thus an FDA regulated intervention.

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Organizational Data

  •   DRKS00004030
  •   2012/10/18
  •   2009/01/07
  •   no
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Secondary IDs

  •   NCT00819156  (ClinicalTrials.gov)
  •   FE200486 CS12  (Ferring Pharmaceuticals)
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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

  •   Interventional
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  •   Randomized controlled trial
  •   Open (masking not used)
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  •   Other
  •   Treatment
  •   Parallel
  •   II
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Primary Outcome

- Number of Patients With Testosterone <=0.5 Nanograms/Milliliter From Day 28 to Day 364; time frame: 12 months; Number of patients who achieved a testosterone level considered a castration level.

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Secondary Outcome

- Number of Patients With Testosterone Level <=0.5 Nanogram/Milliliter From Day 28 to Day 364 for Patients With Testosterone <=0.5 Nanogram/Milliliter at Day 28; time frame: Day 28 - 364; Number of patients who maintained a castration level of testosterone (<=0.5 Nanogram/Milliliter) while on a maintenance dose of Degarelix from Day 28 - 364.
- Number of Patients With Testosterone <=0.5 Nanogram/Milliliter at Day 28.; time frame: Day 28; The number of patients who achieved the <=0.5 nanogram/milliliter level for serum testosterone after the initial dose cycle.
- Number of Patients With Testoterone <=0.5 Nanogram/Milliliter at Day 3.; time frame: Day 3; The number of patients who achieved the <=0.5 nanogram/milliliter level for serum testosterone after 3 days.
- Days to 50 Percent Reduction in Prostate-Specific Antigen; time frame: Day 0 (post dose) to Day 364; Median number of days after the first dose of Degarelix when the prostate-specific antigen levels fell to 50 percent of the baseline value.
- Days to 90 Percent Reduction in Prostate-Specific Antigen; time frame: Day 0 (post dose) to Day 364; Median number of days after the first dose of Degarelix when the prostate-specific antigen levels fell to 90 percent of the baseline value.
- Days to Prostate-Specific Antigen Progression; time frame: Day 0 (post dose) to Day 364; Median days to prostate-specific antigen increase of >= 50 percent and >=5 nanograms/milliliter compared to nadir on two consecutive visits at least two weeks apart.
- Median Serum Testosterone Levels; time frame: Day 0 (Baseline), Days 1,3,7,14, and 364
- Median Prostate-specific Antigen Levels; time frame: Day 0 (Baseline), Days 3, 7, 14, and 364
- Median Values of Di-Hydrotestosterone; time frame: Day 0 (Baseline), Days 1, 3, 7, 14, and 364
- Median Values for Serum Luteinizing Hormone; time frame: Day 0 (Baseline), Days 1, 3, 7, 14, and 364
- Median Values for Follicle Stimulation Hormone; time frame: Day 0 (Baseline), Days 1, 3, 7, 14, and 364
- The Number of Patients With Abnormal Liver Function Tests; time frame: 364 days; The number of patients who had abnormal (defined as above upper limit of normal range(ULN)) alanine aminotransferase(ALT), aspartate aminotransferase levels, and bilirubin levels. Also includes the number of patients who had ALT increases >3x ULN, and patients with ALT increases >3x ULN with concurrent increases in bilirubin >1.5 ULN.
- The Number of Patients With Markedly Abnormal Changes in Vital Signs or Body Weight; time frame: Day 364; Vital sign and body weight values at the end of the trial are compared to baseline values. The table represents the number of patients in each group with normal baseline values and markedly abnormal end-of-study values.

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Countries of Recruitment

  •   Belgium
  •   Germany
  •   Hungary
  •   Netherlands
  •   Poland
  •   Romania
  •   Russian Federation
  •   South Africa
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Locations of Recruitment

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Recruitment

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  •   2004/02/27
  •   189
  •   Multicenter trial
  •   International
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Inclusion Criteria

  •   Male
  •   18   Years
  •   no maximum age
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Additional Inclusion Criteria

- Written informed consent prior to any study related procedures

- Proven prostate cancer in need for endocrine treatment, except for neoadjuvant
hormonal therapy, but including patients with a rising PSA further to prostatectomy
or radiotherapy

- ECOG score to be equal to or above 2

- Testosterone level within age-specific normal range

- PSA value equal to or above 2 ng/ml

- Life expectancy of at least 6 months

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Exclusion Criteria

- Previous or current hormonal treatment of prostate cancer

- Recent or current treatment with any drugs modifying the testosterone level

- Candidate for curative treatment such as prostatectomy or radiotherapy

- History of severe asthma, anaphylactic reactions, angioedema, angioneurotic oedema or
Quincke's Oedema

- Hypersensitivity towards any component of degarelix or mannitol

- Cancer disease within the last 5 years except for prostate cancer and some skin
cancers

- Signs of liver impairment shown as elevated serum ALT or serum bilirubin

- Known hepatic disease

- Other laboratory abnormalities that judged by the investigator would interfere with
the patients participation in the trial or the evaluation of the trial results

- Clinically significant disorder including excessive alcohol or drug abuse that may
interfere with trial participation or influence the conclusion of the trial as judged
by the investigator

- Mental incapacity or language barrier precluding adequate understanding or
cooperation

- Having received an investigational product within the last 12 weeks preceding the
trial

- Previous participation in this trial

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Addresses

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    • Ferring Pharmaceuticals
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    • Ferring Pharmaceuticals
    • Clinical Development Support 
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    • Ferring Pharmaceuticals
    • Clinical Development Support 
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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 complete, follow-up complete
  •   2005/09/01
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Trial Publications, Results and other Documents

  •   Van Poppel H, Tombal B, de la Rosette JJ, Persson BE, Jensen JK, Kold Olesen T. Degarelix: a novel gonadotropin-releasing hormone (GnRH) receptor blocker--results from a 1-yr, multicentre, randomised, phase 2 dosage-finding study in the treatment of prostate cancer. Eur Urol. 2008 Oct;54(4):805-13. doi: 10.1016/j.eururo.2008.04.065. Epub 2008 May 8.; 18538469
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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.