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
  Purpose

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.


Condition Intervention Phase
Prostate Cancer
Drug: Degarelix 80 mg / Degarelix 80 mg
Drug: Degarelix 160 mg / Degarelix 160 mg
Drug: Leuprolide 7.5 mg / Degarelix 80 mg
Drug: Leuprolide 7.5 mg / Degarelix 160 mg
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: 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

Resource links provided by NLM:


Further study details as provided by Ferring Pharmaceuticals:

Primary Outcome Measures:
  • 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.


Secondary Outcome Measures:
  • 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 ]

Enrollment: 386
Study Start Date: March 2007
Study Completion Date: December 2011
Primary Completion Date: October 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.
Drug: Degarelix 80 mg / Degarelix 80 mg
Other Name: Firmagon
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.

Drug: Degarelix 160 mg / Degarelix 160 mg
Other Name: Firmagon
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.

Drug: Leuprolide 7.5 mg / Degarelix 80 mg
Other Names:
  • Firmagon
  • Lupron
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.

Drug: Leuprolide 7.5 mg / Degarelix 160 mg
Other Names:
  • Firmagon
  • Lupron

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00451958

  Show 69 Study Locations
Sponsors and Collaborators
Ferring Pharmaceuticals
Investigators
Study Director: Clinical Development Support Ferring Pharmaceuticals
  More Information

No publications provided

Responsible Party: Ferring Pharmaceuticals
ClinicalTrials.gov Identifier: NCT00451958     History of Changes
Other Study ID Numbers: FE200486 CS21A, 2006-006913-34
Study First Received: March 23, 2007
Results First Received: October 10, 2012
Last Updated: March 20, 2013
Health Authority: United States: Food and Drug Administration

Keywords provided by Ferring Pharmaceuticals:
Degarelix
prostate cancer

Additional relevant MeSH terms:
Prostatic Neoplasms
Genital Diseases, Male
Genital Neoplasms, Male
Neoplasms
Neoplasms by Site
Prostatic Diseases
Urogenital Neoplasms
Androgens
Leuprolide
Antineoplastic Agents
Antineoplastic Agents, Hormonal
Fertility Agents
Fertility Agents, Female
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Pharmacologic Actions
Physiological Effects of Drugs
Reproductive Control Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on October 23, 2014