Trial document





This study has been imported from ClinicalTrials.gov without additional data checks.
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  DRKS00004084

Trial Description

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Title

An Open-Label, Multi-Centre, Randomised, Parallel-Arm One-Year Trial, Comparing the Efficacy and Safety of Degarelix Three-Month Dosing Regimen With Goserelin Acetate in Patients With Prostate Cancer Requiring Androgen Deprivation Therapy

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Trial Acronym

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URL of the Trial

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Brief Summary in Lay Language

A phase 3, open-label, parallel group, one year trial comparing the efficacy and safety of
degarelix 3-month depot with the established therapy goserelin acetate 3-month implant in
patients with prostate cancer.

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Brief Summary in Scientific Language

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Organizational Data

  •   DRKS00004084
  •   2012/08/24
  •   2009/07/03
  •   no
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Secondary IDs

  •   NCT00946920  (ClinicalTrials.gov)
  •   FE200486 CS35  (Ferring Pharmaceuticals)
  •   2008-005276-27 
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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
  •   Drug: Goserelin acetate
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Characteristics

  •   Interventional
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  •   Randomized controlled trial
  •   Open (masking not used)
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  •   Active control (effective treament of control group)
  •   Treatment
  •   Parallel
  •   III
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Primary Outcome

- Cumulative Probability of Testosterone at Castrate Level (≤0.5 ng/mL) With Degarelix; time frame: From Day 28 to Day 364; This co-primary outcome measure was used to demonstrate that degarelix is effective with respect to achieving and maintaining testosterone suppression to castrate levels, evaluated as the proportion of patients with testosterone suppression ≤0.5 ng/mL from Day 28 to Day 364.
- Difference in Cumulative Probability of Testosterone at Castrate Level (≤0.5 ng/mL) Between Degarelix and Goserelin; time frame: Day 3 to Day 364; This co-primary outcome measure was used to establish non-inferiority of degarelix as compared to goserelin with regard to achieving and maintaining testosterone suppression at castrate levels (≤0.5 ng/mL) from Day 3 to Day 364, using a non-inferiority margin of 5 percentage points.

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Secondary Outcome

- Serum Levels of Testosterone Over Time; time frame: Baseline and after 1, 2, 3, 6 and 13 months; Median testosterone levels are presented as absolute values at Baseline (in Baseline measures) and after 1, 2, 3, 6 and 13 months (below). One treatment month equals 28 days.
- Percent Change in Serum Levels of Prostate-specific Antigen (PSA) Over Time; time frame: Baseline and after 1, 2, 3, 6 and 13 months; Serum PSA levels are presented as mean percent change from Baseline (in Baseline measures) after 1, 2, 3, 6 and 13 months. One treatment month equals 28 days.
- Change in Health-related Quality of Life (HRQoL), as Measured by Short Form-36 (SF-36) Score at Month 10 and Month 13 Compared to Baseline; time frame: At baseline, 10 months and 13 months; The SF-36 is a multi-purpose, short-form health survey with only 36 questions and with a minimum score of 0 and a maximum score of 100. The higher score the better health. It yields an 8-scale profile of functional health and well-being scores as well as psychometrically-based physical and mental health summary measures and a preference-based health utility index. The SF-36 has proven useful in surveys of general and specific populations, comparing the relative burden of diseases, and in differentiating the health benefits produced by a wide range of different treatments.
- Change in International Prostate Symptom Score (IPSS) Score at Months 1, 4, 7, and 13 Compared to Baseline; time frame: At baseline, 1 month, 4 months, 7 months and 13 months; IPSS is used to assess severity of lower urinary tract symptoms and to monitor the progress of symptoms once treatment has been initiated. It contains 7 questions regarding incomplete emptying, frequency, intermittency, urgency, weak stream, straining, and nocturia. Each question is assigned a score of 0-5 (i.e. the minimum total score is 0 and the maximum is 35). A score of "0" corresponds to a response of "not at all" for the first six symptoms and "none" for nocturia, and a score of 5 corresponds to a response of "almost always" for the first six symptoms and "5 times or more" for nocturia.

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Countries of Recruitment

  •   United States
  •   Belgium
  •   Canada
  •   Czech Republic
  •   Finland
  •   Germany
  •   Hungary
  •   Mexico
  •   Netherlands
  •   Poland
  •   Romania
  •   Russian Federation
  •   Ukraine
  •   United Kingdom
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Locations of Recruitment

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Recruitment

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  •   2009/06/30
  •   859
  •   Multicenter trial
  •   International
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Inclusion Criteria

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

- 18 years or older.

- Has a histological confirmed prostate cancer Gleason graded).

- Has a screening testosterone above 2.2 ng/mL.

- Rising prostate-specific antigen (PSA).

- Has Eastern Cooperative Oncology Group (ECOG) score of ≤ 2.

- Has a life expectancy of at least one year.

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Exclusion Criteria

- Current or previous hormone therapy.

- Has received therapy with finasteride and dutasteride within 12 weeks and 25 weeks,
respectively, prior to screening.

- Has a history of severe untreated asthma, anaphylactic reactions, or severe urticaria
and/or angioedema.

- Has a heart insufficiency.

- Has a previous history or presence of another malignancy, other than prostate cancer
or treated squamous/basal cell carcinoma of the skin, within the last five years.

- Has a clinically significant medical condition (other than prostate cancer)
including, but not limited to, renal, haematological, gastrointestinal, endocrine,
cardiac, neurological, or psychiatric disease and alcohol or drug abuse or any other
condition which may affect the patient's health or the outcome of the trial as judged
by the Investigator.

- Has received an investigational drug within the last 28 days before the Screening
Visit or longer if considered to possibly influencing the outcome of the current
trial.

- Is candidate for curative therapy, i.e. radical prostatectomy or radiotherapy.

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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
  •   2011/03/01
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Trial Publications, Results and other Documents

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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 .
  •   4
  •   2016/01/14


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