Trial · Interventional

CompletedPhase 3Results postedRegistry data

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

NCTNCT00451958Other idFE200486 CS21AOther id2006-006913-34

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Overview

Status: Completed
Phase: Phase 3
Enrollment: 386 participants (actual)
Sponsor: Ferring Pharmaceuticals · Industry
Design: Randomized · Open label (no masking)
Countries: 12 countries
United States, Canada, Czechia, Germany, Hungary, Mexico, Netherlands, Puerto Rico, Romania, Russia, Ukraine, United Kingdom
Start: Mar 2007
Primary completion: Oct 2011
Completion: Dec 2011
First posted: 26 Mar 2007 (estimated)
Last update posted: 21 Mar 2013 (estimated)
Conditions: Prostate Cancer

Timeline

1 trial · 1 completed · 1 with posted results

Completed
Ongoing
Not yet recruiting
Stopped
Estimated dates (est.)
Results posted

200720082009201020112012

Ph 3
A Long-term Extension Study Evaluating a One-Month Dosing Regimen of Degarelix in Prostate Cancer Requiring Androgen Ablation Therapy
NCT00451958
Mar 2007 to Dec 2011

Registry summary

Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.

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.

Interventions

Degarelix 80 mg / Degarelix 80 mgDrug
Degarelix 160 mg / Degarelix 160 mgDrug
Leuprolide 7.5 mg / Degarelix 80 mgDrug
Leuprolide 7.5 mg / Degarelix 160 mgDrug

Arms4

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.
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.
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.
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.

Primary outcomes2

Outcomes the sponsor listed as primary.

Number of Participants With Markedly Abnormal Values in Vital Signs and Body Weight
Time frame · Up to 4 years of treatment
Registry description
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
Registry description
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 outcomes(6)

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
Registry description
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
Registry description
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
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
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
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

Posted results

Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.

Primary outcome results

Primary outcomeNumber· Up to 4 years of treatment

Number of Participants With Markedly Abnormal Values in Vital Signs and Body Weight

Group	Value (participants)
Degarelix 80 mg / Degarelix 80 mg	3
Degarelix 160 mg / Degarelix 160 mg	6
Leuprolide 7.5 mg / Degarelix 80 mg	3
Leuprolide 7.5 mg / Degarelix 160 mg	6

Primary outcomeNumber· Up to 4 years of treatment

Number of Participants With Markedly Abnormal Values in Safety Laboratory Variables

Group	Value (participants)
Degarelix 80 mg / Degarelix 80 mg	11
Degarelix 160 mg / Degarelix 160 mg	9
Leuprolide 7.5 mg / Degarelix 80 mg	6
Leuprolide 7.5 mg / Degarelix 160 mg	5

Secondary and other outcome results(6)

Secondary outcomeNumber· Until all participants have received at least 5 years of treatment and at a frequency of every 3 months

Percentage of Participants With no Prostate-specific Antigen (PSA) Progression

Group	Value (percentage of participants)
Degarelix 80 mg / Degarelix 80 mg	100
Degarelix 160 mg / Degarelix 160 mg	99.5
Leuprolide 7.5 mg / Degarelix 80 mg	98.6
Leuprolide 7.5 mg / Degarelix 160 mg	100

Secondary outcomeNumber· Until all participants have received at least 5 years of treatment and at a frequency of every 6 months

Percentage of Participants With Testosterone Level Maintained at <=0.5 ng/mL From Day 28 in CS21 and Onwards

Group	Value (percentage)
Degarelix 80 mg / Degarelix 80 mg	99.5
Degarelix 160 mg / Degarelix 160 mg	100
Leuprolide 7.5 mg / Degarelix 80 mg	98.6
Leuprolide 7.5 mg / Degarelix 160 mg	97.6

Secondary outcomeMedian· From time of switch to Day 56

Serum Levels of Testosterone From the Time of Switch From Leuprolide to Degarelix up to Day 56

Group	Value (ng/mL)
Leuprolide 7.5 mg/ Degarelix 240/80 mg	0.076
Leuprolide 7.5 mg/ Degarelix 240/160 mg	0.074

Secondary outcomeMedian· From time of switch to Day 56

Serum Levels of PSA From the Time of Switch From Leuprolide to Degarelix to Day 56

Group	Value (ng/mL)
Leuprolide 7.5 mg/ Degarelix 240/80 mg	0.4
Leuprolide 7.5 mg/ Degarelix 240/160 mg	0.4

Secondary outcomeMedian· From time of switch to Day 56

Serum Levels of Luteinizing Hormone (LH) From the Time of Switch From Leuprolide to Degarelix to Day 56

Group	Value (International units/Liter (IU/L))
Leuprolide 7.5 mg/ Degarelix 240/80 mg	0.035
Leuprolide 7.5 mg/ Degarelix 240/160 mg	0.035

Secondary outcomeMedian· From time of switch to Day 56

Serum Levels of Follicle Stimulating Hormone (FSH) From the Time of Switch From Leuprolide to Degarelix to Day 56

Group	Value (International units/Liter (IU/L))
Leuprolide 7.5 mg/ Degarelix 240/80 mg	4.8
Leuprolide 7.5 mg/ Degarelix 240/160 mg	4.4

Adverse events, as posted

Adverse events as posted: participants affected out of participants at risk, by group
Group	Deaths	Serious events	Other events
Degarelix 80 mg / Degarelix 80 mgThe 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.	–	43 / 207	181 / 207
Degarelix 160 mg / Degarelix 160 mgThe 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.	–	60 / 202	177 / 202
Leuprolide 7.5 mg / Degarelix 80 mgDuring 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.	–	23 / 69	63 / 69
Leuprolide 7.5 mg / Degarelix 160 mgDuring 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.	–	22 / 66	58 / 66

Each cell reads participants affected / participants at risk, as the registry posted them.

Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works

Studies0

Studies that cite this trial.

No study cites this trial.

Other registry references

References listed at the registry that are not in PepBank. They link to PubMed.

DerivedZengerling F, Jakob JJ, Schmidt S, Meerpohl JJ, Blumle A, Schmucker C, Mayer B, Kunath F. Degarelix for treating advanced hormone-sensitive prostate cancer. Cochrane Database Syst Rev. 2021 Aug 5;8(8):CD012548. doi: 10.1002/14651858.CD012548.pub2. PMID 34350976

Eligibility

Who could join, as posted.

Sex: Male
Age: from 18 Years
Healthy volunteers: Not accepted

Inclusion and exclusion criteria, as posted

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.

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