Trial document





This study has been imported from ClinicalTrials.gov without additional data checks.
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  DRKS00004153

Trial Description

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Title

An Open-Label, Multi-Centre, Uncontrolled, Exploratory Trial Investigating Degarelix One-Month Dosing Regimen as Second-Line Hormonal Treatment After PSA-Failure in GnRH Agonist Treated Patients With Prostate Cancer

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Trial Acronym

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URL of the Trial

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Brief Summary in Lay Language

This was an open-label, multi-centre, uncontrolled, exploratory trial with a duration of 12
months in two cohorts. The trial aimed to investigate Degarelix as a second-line hormonal
treatment in Prostate Cancer patients who experienced PSA-Failure following
gonadotropin-releasing hormone (GnRH) agonist treatment. The two cohorts differ in
Testosterone levels at inclusion.

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Brief Summary in Scientific Language

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Organizational Data

  •   DRKS00004153
  •   2012/12/18
  •   2008/08/18
  •   no
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Secondary IDs

  •   2008-000585-22 
  •   NCT00738673  (ClinicalTrials.gov)
  •   FE200486 CS27  (Ferring Pharmaceuticals)
  •   2008-000585-22 
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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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  •   Single arm study
  •   Open (masking not used)
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  •   Uncontrolled/Single arm
  •   Treatment
  •   Single (group)
  •   II
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Primary Outcome

- Participants' Response in Prostate-Specific Antigen (PSA) Level at Three Months As Compared to Baseline; time frame: Day 0 (baseline), 3 months; Response to treatment was defined as:
Response (stabilisation or decrease): Difference ≤ +10% of Baseline level
No response (increase): Difference > +10% of Baseline level

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Secondary Outcome

- Participants' Response in Prostate-Specific Antigen (PSA) Level at One Month As Compared to Baseline; time frame: Day 0 (baseline), 1 month; Response to treatment was defined as:
Response (stabilisation or decrease): Difference ≤ +10% of Baseline level
No response (increase): Difference > +10% of Baseline level.
Per protocol, the one month timeframe was only analyzed for cohort 2.
- Participants' Response in Prostate-Specific Antigen (PSA) Level at Two Months As Compared to Baseline; time frame: Day 0 (baseline), 2 months; Response to treatment was defined as:
Response (stabilisation or decrease): Difference ≤ +10% of Baseline level
No response (increase): Difference > +10% of Baseline level.
Per protocol, the two month timeframe was only analyzed for cohort 2.
- Participants at Testosterone Castrate Level Throughout the Study; time frame: up to month 12; Participants who had no post-baseline serum testosterone level above castrate level which was <=0.5 ng/mL.
- Change From Baseline in Serum Levels of Testosterone at the Last Visit; time frame: Day 0 (baseline), up to month 12 (last visit)
- Change From Baseline in Serum Levels of Prostate-Specific Antigen (PSA) at Last Visit; time frame: Day 0 (baseline), up to month 12 (last visit)
- Percent Change From Baseline in Serum Levels of Luteinising Hormone (LH) at the Last Visit; time frame: Day 0 (baseline), up to month 12 (last visit); LH is measured in IU/L
- Change From Baseline in Serum Levels of Follicle-Stimulating Hormone (FSH) at the Last Visit; time frame: Day 0 (baseline), up to month 12 (last visit)
- Participants at Testosterone Level <=0.2 ng/mL Throughout the Study; time frame: up to month 12; Participants in Cohort 2 who had no post-baseline serum testosterone level above 0.2 ng/mL.
- Participants at Testosterone Level <=0.32 ng/mL Throughout the Study; time frame: up to month 12; Participants in Cohort 2 who had no post-baseline serum testosterone level above 0.32 ng/mL
- Participants With Prostate-Specific Antigen (PSA) Progression Throughout the Study; time frame: up to month 12; Counts of participants who had PSA progression during the study. PSA progression was defined as PSA >+10% of baseline value.
- Kaplan-Meier Estimate for Overall Survival; time frame: up to month 12; The overall survival time was defined as number of days from first treatment dose to date of death. If a patient did not die then the patient's data were censored at the date of last visit.

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

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Recruitment

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  •   2008/07/31
  •   12
  •   Multicenter trial
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Inclusion Criteria

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

- Patient has given written informed consent before any trial-related activity is
performed.

- Patient is 18 years or older.

- Histologically confirmed prostate cancer.

- Patient has received GnRH receptor agonist therapy for a duration of at least 12
months (the first dose of GnRH-antagonist is to be administered when the next dose of
the GnRH-agonist would have been due).

- Patient has experienced rising PSA levels although receiving GnRH agonist therapy,
defined as two consecutive rises of PSA at least two weeks apart in two 50% increases
over the nadir, and at least one PSA value of >2.5 ng/mL within the last six months.

- Testosterone on castrate level (defined as ≤ 0.5 ng/mL) (cohort 1); Testosterone ≥0.2
ng/mL at inclusion (cohort 2)

- Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1, or 2.

- Estimated life expectancy at least 12 months.

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Exclusion Criteria

- 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.

- Ongoing GnRH agonist therapy (last dose of previous GnRH agonist must have been
received before Visit 1).

- Any pre-trial secondary hormonal manipulation (including antiandrogens) after PSA
increase as described as above and before trial entry. Antiandrogens as part of
complete androgen blockade must have been discontinued at least three months before
first dose of trial medication.

- Previous or current treatment with chemotherapy (e.g. estramustine) for prostate
cancer.

- Known hypersensitivity towards any component of the investigational medical product.

- History of severe uncontrolled asthma, anaphylactic reactions, or severe urticaria
and/or angioedema.

- Known or suspected clinically significant liver and/or biliary disease.

- Any clinically significant laboratory abnormalities, disorders, or other condition,
including alcohol or drug abuse, which may affect the patient's health or the outcome
of the trial as judged by the Investigator.

- Patient has a clinically significant disorder (other than prostate cancer) including,
but not limited to, renal, hematological, 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.

- Patient has a mental incapacity or language barriers precluding adequate
understanding or co-operation.

- Patient has received an investigational drug within the last 28 days preceding
screening visit. Or longer if considered to possibly influencing the outcome of the
current trial.

- Previous participation in any degarelix 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
  •   2011/12/01
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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 .
  •   5
  •   2016/01/14


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