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A Long-term Extension Study Evaluating a One-Month Dosing Regimen of Degarelix in Prostate Cancer Requiring Androgen Ablation Therapy

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Ferring Pharmaceuticals
ClinicalTrials.gov Identifier:
NCT00451958
First received: March 23, 2007
Last updated: March 20, 2013
Last verified: March 2013

March 23, 2007
March 20, 2013
March 2007
October 2011   (final data collection date for primary outcome measure)
  • Number of Participants With Markedly Abnormal Values in Vital Signs and Body Weight [ Time Frame: Up to 4 years of treatment ] [ Designated as safety issue: No ]
    This outcome measure included incidence of markedly abnormal changes in blood pressure (systolic and diastolic), pulse, and body weight. The table presents the number of participants with normal baseline (from main CS21 study, NCT00295750) and at least one post-baseline markedly abnormal value during CS21A.
  • Number of Participants With Markedly Abnormal Values in Safety Laboratory Variables [ Time Frame: Up to 4 years of treatment ] [ Designated as safety issue: No ]
    This outcome measure included incidence of markedly abnormal changes in safety laboratory values. The table presents the number of participants with normal baseline (from main CS21 trial, NCT00295750) and at least one post-baseline markedly abnormal value during CS21A. Only the laboratory variables that had at least five percentages of participants in either group with abnormal value are presented, more variables were included in the study. ULN=Upper limit of normal.
  • Changes in clinical safety parameters (adverse events including death from any causse, physical examination, vtal signs, ECGs, and body weight)
  • Clinical significant changes in laboratory safety parameters (clinical chemistry, haematology, and urinalysis)
Complete list of historical versions of study NCT00451958 on ClinicalTrials.gov Archive Site
  • Percentage of Participants With no Prostate-specific Antigen (PSA) Progression [ Time Frame: Until all participants have received at least 5 years of treatment and at a frequency of every 3 months ] [ Designated as safety issue: No ]
    PSA progression was defined as two consecutive increases of 50%, and at least 5 ng/mL, compared to nadir (obtained in either CS21, NCT00295750, or CS21A). The figures below present the percentage of participants with no PSA progression at each of the selected time points (there were more time points in the study) along with corresponding 95% confidence intervals (CI).
  • Percentage of Participants With Testosterone Level Maintained at <=0.5 ng/mL From Day 28 in CS21 and Onwards [ Time Frame: Until all participants have received at least 5 years of treatment and at a frequency of every 6 months ] [ Designated as safety issue: No ]

    The results below present the percentage of participants of having testosterone <=0.5 ng/mL at each of the selected time points (there were more time points in the study) from Day 28 in CS21 (NCT00295750) until the end of the CS21A study.

    In all treatment groups approximately 3% per year of the participants had at least one testosterone >0.5 ng/mL during the study.

  • Serum Levels of Testosterone From the Time of Switch From Leuprolide to Degarelix up to Day 56 [ Time Frame: From time of switch to Day 56 ] [ Designated as safety issue: No ]
  • Serum Levels of PSA From the Time of Switch From Leuprolide to Degarelix to Day 56 [ Time Frame: From time of switch to Day 56 ] [ Designated as safety issue: No ]
  • Serum Levels of Luteinizing Hormone (LH) From the Time of Switch From Leuprolide to Degarelix to Day 56 [ Time Frame: From time of switch to Day 56 ] [ Designated as safety issue: No ]
  • Serum Levels of Follicle Stimulating Hormone (FSH) From the Time of Switch From Leuprolide to Degarelix to Day 56 [ Time Frame: From time of switch to Day 56 ] [ Designated as safety issue: No ]
  • Proportion of patients with testosterone level maintained at ≤0.5 ng/mL from start of FE 200486 cs21a and onwards.
  • Proportion of patients treated with degarelix with testosterone level maintained at ≤0.5 ng/mL from Day 28 in FE 200486 CS21 and onwards.
  • Proportion of patients switching from LUPRON DEPOT 7.5 mg to Degarelix with testosterone level maintained below 0.5 ng/mL from Day 28 in Fe 200486 CS21A and onwards.
  • Time to testosterone level above 0.5 ng/mL.
  • Serum levels of testosterone and PSA over time.
  • Time to PSA progression-defined as two consecutive increases of 50%, and at least 5 ng/mL, compared to nadir (obtained in either FE 200486 CS21 or FE 200486 CS21A)
  • Serum levels of testosterone, PSA, LH, and FSH from the time of switch from LUPRON DEPOT to degarelix.
Not Provided
Not Provided
 
A Long-term Extension Study Evaluating a One-Month Dosing Regimen of Degarelix in Prostate Cancer Requiring Androgen Ablation Therapy
An Open-Label, Multi-Centre, Extension Study, Evaluating the Long-Term Safety and Tolerability of Degarelix One-Month Dosing Regimen in Patients With Prostate Cancer Requiring Androgen Ablation Therapy

Participants who completed the FE200486 CS21 study (NCT00295750) could enter the FE200486 CS21A study. The study continued until all non-discontinued participants had received treatment for at least 5 years.

Not Provided
Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Prostate Cancer
  • Drug: Degarelix 80 mg / Degarelix 80 mg
    Other Name: Firmagon
  • Drug: Degarelix 160 mg / Degarelix 160 mg
    Other Name: Firmagon
  • Drug: Leuprolide 7.5 mg / Degarelix 80 mg
    Other Names:
    • Firmagon
    • Lupron
  • Drug: Leuprolide 7.5 mg / Degarelix 160 mg
    Other Names:
    • Firmagon
    • Lupron
  • Experimental: Degarelix 80 mg / Degarelix 80 mg
    The degarelix doses were administered into the abdominal wall every 28 days. A starting dose of 240 mg (40 mg/mL) degarelix was administered on Day 0 as two 3 mL subcutaneous (s.c.) injections. The subsequent doses of 80 mg (20 mg/mL) degarelix were administered as single 4 mL s.c. injections every 28 days for the rest of the study.
    Intervention: Drug: Degarelix 80 mg / Degarelix 80 mg
  • Experimental: Degarelix 160 mg / Degarelix 160 mg

    The degarelix doses were administered into the abdominal wall every 28 days. A starting dose of 240 mg (40 mg/mL) degarelix was administered on Day 0 as two 3 mL subcutaneous (s.c.) injections. The subsequent monthly degarelix maintenance dose of 160 mg (40 mg/mL) degarelix were administered as single 4 mL s.c. injections every 28 days.

    Following the implementation of a protocol amendment, all patients received a monthly degarelix maintenance dose of 80 mg (20 mg/mL) for the rest of the study.

    Intervention: Drug: Degarelix 160 mg / Degarelix 160 mg
  • Experimental: Leuprolide 7.5 mg / Degarelix 80 mg

    During the main CS21 study, leuprolide (Lupron Depot) 7.5 mg was injected into the muscle every 28 days for one year.

    Starting one year after the first dose of leuprolide, degarelix doses were administered into the abdominal wall every 28 days. First, a starting dose of 240 mg (40 mg/mL) degarelix was administered as two 3 mL subcutaneous (s.c.) injections and one month later the participants received either subsequent monthly degarelix maintenance doses of 80 mg (20 mg/mL) or 160 mg (40 mg/mL) every 28 days for the rest of the study.

    Following the implementation of a protocol amendment, all patients received a monthly degarelix maintenance dose of 80 mg (20 mg/mL) for the rest of the study.

    Intervention: Drug: Leuprolide 7.5 mg / Degarelix 80 mg
  • Experimental: Leuprolide 7.5 mg / Degarelix 160 mg

    During the main CS21 study, leuprolide (Lupron Depot) 7.5 mg was injected into the muscle every 28 days for one year.

    Starting one year after the first dose of leuprolide, degarelix doses were administered into the abdominal wall every 28 days. First, a starting dose of 240 mg (40 mg/mL) degarelix was administered as two 3 mL subcutaneous (s.c.) injections and one month later the participants received either subsequent monthly degarelix maintenance doses of 80 mg (20 mg/mL) or 160 mg (40 mg/mL) every 28 days for the rest of the study.

    Following the implementation of a protocol amendment, all patients received a monthly degarelix maintenance dose of 80 mg (20 mg/mL) for the rest of the study.

    Intervention: Drug: Leuprolide 7.5 mg / Degarelix 160 mg
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
386
December 2011
October 2011   (final data collection date for primary outcome measure)

Inclusion/Exclusion Criteria:

  • Patients with histologically proven prostate cancer of all stages in whom endocrine treatment is indicated.
  • Signed informed consent
  • The patients must have completed the FE 200486 CS21 Study.
Male
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States,   Canada,   Czech Republic,   Germany,   Hungary,   Mexico,   Netherlands,   Puerto Rico,   Romania,   Russian Federation,   Ukraine,   United Kingdom
 
NCT00451958
FE200486 CS21A, 2006-006913-34
Yes
Ferring Pharmaceuticals
Ferring Pharmaceuticals
Not Provided
Study Director: Clinical Development Support Ferring Pharmaceuticals
Ferring Pharmaceuticals
March 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP