A Long-term Extension Study Evaluating a One-Month Dosing Regimen of Degarelix in Prostate Cancer Requiring Androgen Ablation Therapy
- Full Text View
- Tabular View
- Study Results
- Disclaimer
- How to Read a Study Record
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 |
- 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.
- 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:
|
|
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:
|
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Male |
| Accepts Healthy Volunteers: | No |
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
Show 69 Study Locations| 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 Neoplasms, Male Urogenital Neoplasms Neoplasms by Site Neoplasms Genital Diseases, Male Prostatic Diseases Androgens Leuprolide Hormones |
Hormones, Hormone Substitutes, and Hormone Antagonists Physiological Effects of Drugs Pharmacologic Actions Antineoplastic Agents, Hormonal Antineoplastic Agents Therapeutic Uses Fertility Agents, Female Fertility Agents Reproductive Control Agents |
ClinicalTrials.gov processed this record on May 16, 2013