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Degarelix as Second-Line Hormonal Treatment After Prostate-specific Antigen (PSA)-Failure in GnRH Agonist Treated Patients With Prostate Cancer

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Ferring Pharmaceuticals
ClinicalTrials.gov Identifier:
NCT00738673
First received: August 18, 2008
Last updated: December 12, 2012
Last verified: December 2012

August 18, 2008
December 12, 2012
July 2008
December 2011   (final data collection date for primary outcome measure)
Participants' Response in Prostate-Specific Antigen (PSA) Level at Three Months As Compared to Baseline [ Time Frame: Day 0 (baseline), 3 months ] [ Designated as safety issue: No ]

Response to treatment was defined as:

  • Response (stabilisation or decrease): Difference ≤ +10% of Baseline level
  • No response (increase): Difference > +10% of Baseline level
• To study whether treatment with degarelix may stabilise or reverse PSA progression in patients with prostate cancer after failure of GnRH agonist treatment [ Time Frame: After 3 months treatment ] [ Designated as safety issue: No ]
Complete list of historical versions of study NCT00738673 on ClinicalTrials.gov Archive Site
  • Participants' Response in Prostate-Specific Antigen (PSA) Level at One Month As Compared to Baseline [ Time Frame: Day 0 (baseline), 1 month ] [ Designated as safety issue: No ]

    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 ] [ Designated as safety issue: No ]

    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 ] [ Designated as safety issue: No ]
    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) ] [ Designated as safety issue: No ]
  • 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) ] [ Designated as safety issue: No ]
  • 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) ] [ Designated as safety issue: No ]
    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) ] [ Designated as safety issue: No ]
  • Participants at Testosterone Level <=0.2 ng/mL Throughout the Study [ Time Frame: up to month 12 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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.
• To investigate testosterone control • To investigate LH/FSH control • To investigate PSA progression free survival • To investigate overall survival • To investigate drug safety of degarelix [ Time Frame: 3 months and 12 months ] [ Designated as safety issue: Yes ]
Not Provided
Not Provided
 
Degarelix as Second-Line Hormonal Treatment After Prostate-specific Antigen (PSA)-Failure in GnRH Agonist Treated Patients With Prostate Cancer
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

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.

Not Provided
Interventional
Phase 2
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Prostate Cancer
Drug: degarelix
Starting dose of 240 mg (40 mg/mL). Maintenance doses of 80 mg (20 mg/mL).
Other Name: FE200486
Experimental: Degarelix

Starting dose: 240 mg by subcutaneous (s.c.) injection in the abdomen on Day 0.

Maintenance dose: a maximum of 11 doses of 80 mg degarelix were given 28 days apart via single s.c. injections.

Intervention: Drug: degarelix
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
37
December 2011
December 2011   (final data collection date for primary outcome measure)

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.

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.
Male
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Germany
 
NCT00738673
FE200486 CS27, 2008-000585-22
No
Ferring Pharmaceuticals
Ferring Pharmaceuticals
Not Provided
Study Director: Clinical Development Support Ferring Pharmaceuticals
Ferring Pharmaceuticals
December 2012

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