The efficacy and safety of degarelix: a 12-month, comparative, randomized, open-label, parallel-group phase III study in patients with prostate cancer.

Klotz L, Boccon-Gibod L, Shore ND, Andreou C, Persson BE, Cantor P, Jensen JK, Olesen TK, Schröder FH

BJU international1 Dec 2008Cited by 402 (Europe PMC)

PMID19035858DOI10.1111/j.1464-410x.2008.08183.xPepBankPUB-19035858

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Summary

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Text rights: Publisher copyright. Results still quote short attributed sentences.

Results from this study24

24 results from studies that gave the peptide. 24 results from people.

01HumanRandomized controlled trialEfficacy outcome
In prostate cancer patients, sustained testosterone suppression occurred in 97.2% with degarelix 240/80 mg versus 96.4% with leuprolide.
In plain wordsIn prostate cancer patients, sustained testosterone suppression occurred in 97.2% with degarelix 240/80 mg versus 96.4% with leuprolide.
Peptide
Degarelix
Outcome
Direction not reportedSustained testosterone response
Study
n: not reported in source
Comparator
leuprolide 7.5 mg monthly
Analysis
Primary
Outcome group
Sex hormones and fertility · Endocrine and hormones
Studied dose
240/80 mg · subcutaneous · 12 monthsAs given in this study (human).
Measurements
Patients with sustained testosterone suppression to <=0.5 ng/mL (day 28 to day 364, ITT)
97.2%
degarelix 240/80 mg
Patients with sustained testosterone suppression to <=0.5 ng/mL (day 28 to day 364, ITT)
96.4%
leuprolide 7.5 mg monthly
Source sentences
Summary
This was achieved by 97.2%, 98.3% and 96.4% of patients in the degarelix 240/80 mg, degarelix 240/160 mg and leuprolide groups, respectively (ITT population).
3 context sentences(design, population, supporting numbers)
Summary · context
The primary endpoint of the trial was suppression of testosterone to <or=0.5 ng/mL at all monthly measurements from day 28 to day 364, thus defining the treatment response.
Summary · context
In all, 610 patients with adenocarcinoma of the prostate (any stage; median age 72 years; median testosterone 3.93 ng/mL, median prostate-specific antigen, PSA, level 19.0 ng/mL) were randomized and received study treatment.
Summary · context
Three dosing regimens were evaluated: a starting dose of 240 mg of degarelix subcutaneous (s.c.) for 1 month, followed by s.c. maintenance doses of 80 mg or 160 mg monthly, or intramuscular (i.m.) leuprolide doses of 7.5 mg monthly.
Report a problemFND-1903585801
02HumanRandomized controlled trialEfficacy outcome
In prostate cancer patients, sustained testosterone suppression occurred in 98.3% with degarelix 240/160 mg versus 96.4% with leuprolide.
In plain wordsIn prostate cancer patients, sustained testosterone suppression occurred in 98.3% with degarelix 240/160 mg versus 96.4% with leuprolide.
Peptide
Degarelix
Outcome
Direction not reportedSustained testosterone response
Study
n: not reported in source
Comparator
leuprolide 7.5 mg monthly
Analysis
Primary
Outcome group
Sex hormones and fertility · Endocrine and hormones
Studied dose
240/160 mg · subcutaneous · 12 monthsAs given in this study (human).
Measurements
Patients with sustained testosterone suppression to <=0.5 ng/mL (day 28 to day 364, ITT)
98.3%
degarelix 240/160 mg
Patients with sustained testosterone suppression to <=0.5 ng/mL (day 28 to day 364, ITT)
96.4%
leuprolide 7.5 mg monthly
Source sentences
Summary
This was achieved by 97.2%, 98.3% and 96.4% of patients in the degarelix 240/80 mg, degarelix 240/160 mg and leuprolide groups, respectively (ITT population).
3 context sentences(design, population, supporting numbers)
Summary · context
The primary endpoint of the trial was suppression of testosterone to <or=0.5 ng/mL at all monthly measurements from day 28 to day 364, thus defining the treatment response.
Summary · context
In all, 610 patients with adenocarcinoma of the prostate (any stage; median age 72 years; median testosterone 3.93 ng/mL, median prostate-specific antigen, PSA, level 19.0 ng/mL) were randomized and received study treatment.
Summary · context
Three dosing regimens were evaluated: a starting dose of 240 mg of degarelix subcutaneous (s.c.) for 1 month, followed by s.c. maintenance doses of 80 mg or 160 mg monthly, or intramuscular (i.m.) leuprolide doses of 7.5 mg monthly.
Report a problemFND-1903585802
03HumanRandomized controlled trialEfficacy outcome
In prostate cancer patients, sustained testosterone suppression occurred in 96.4% with leuprolide versus 97.2% with degarelix 240/80 mg.
In plain wordsIn prostate cancer patients, sustained testosterone suppression occurred in 96.4% with leuprolide versus 97.2% with degarelix 240/80 mg.
Peptide
Leuprolide
Outcome
Direction not reportedSustained testosterone response versus lower degarelix dose
Study
n: not reported in source
Comparator
degarelix 240/80 mg
Analysis
Primary
Outcome group
Sex hormones and fertility · Endocrine and hormones
Studied dose
7.5 mg monthly · intramuscular · 12 monthsAs given in this study (human).
Measurements
Patients with sustained testosterone suppression to <=0.5 ng/mL (day 28 to day 364, ITT)
96.4%
leuprolide 7.5 mg monthly
Patients with sustained testosterone suppression to <=0.5 ng/mL (day 28 to day 364, ITT)
97.2%
degarelix 240/80 mg
Source sentences
Summary
This was achieved by 97.2%, 98.3% and 96.4% of patients in the degarelix 240/80 mg, degarelix 240/160 mg and leuprolide groups, respectively (ITT population).
3 context sentences(design, population, supporting numbers)
Summary · context
The primary endpoint of the trial was suppression of testosterone to <or=0.5 ng/mL at all monthly measurements from day 28 to day 364, thus defining the treatment response.
Summary · context
In all, 610 patients with adenocarcinoma of the prostate (any stage; median age 72 years; median testosterone 3.93 ng/mL, median prostate-specific antigen, PSA, level 19.0 ng/mL) were randomized and received study treatment.
Summary · context
Three dosing regimens were evaluated: a starting dose of 240 mg of degarelix subcutaneous (s.c.) for 1 month, followed by s.c. maintenance doses of 80 mg or 160 mg monthly, or intramuscular (i.m.) leuprolide doses of 7.5 mg monthly.
Report a problemFND-1903585803
04HumanRandomized controlled trialEfficacy outcome
In prostate cancer patients, sustained testosterone suppression occurred in 96.4% with leuprolide versus 98.3% with degarelix 240/160 mg.
In plain wordsIn prostate cancer patients, sustained testosterone suppression occurred in 96.4% with leuprolide versus 98.3% with degarelix 240/160 mg.
Peptide
Leuprolide
Outcome
Direction not reportedSustained testosterone response versus higher degarelix dose
Study
n: not reported in source
Comparator
degarelix 240/160 mg
Analysis
Primary
Outcome group
Sex hormones and fertility · Endocrine and hormones
Studied dose
7.5 mg monthly · intramuscular · 12 monthsAs given in this study (human).
Measurements
Patients with sustained testosterone suppression to <=0.5 ng/mL (day 28 to day 364, ITT)
96.4%
leuprolide 7.5 mg monthly
Patients with sustained testosterone suppression to <=0.5 ng/mL (day 28 to day 364, ITT)
98.3%
degarelix 240/160 mg
Source sentences
Summary
This was achieved by 97.2%, 98.3% and 96.4% of patients in the degarelix 240/80 mg, degarelix 240/160 mg and leuprolide groups, respectively (ITT population).
3 context sentences(design, population, supporting numbers)
Summary · context
The primary endpoint of the trial was suppression of testosterone to <or=0.5 ng/mL at all monthly measurements from day 28 to day 364, thus defining the treatment response.
Summary · context
In all, 610 patients with adenocarcinoma of the prostate (any stage; median age 72 years; median testosterone 3.93 ng/mL, median prostate-specific antigen, PSA, level 19.0 ng/mL) were randomized and received study treatment.
Summary · context
Three dosing regimens were evaluated: a starting dose of 240 mg of degarelix subcutaneous (s.c.) for 1 month, followed by s.c. maintenance doses of 80 mg or 160 mg monthly, or intramuscular (i.m.) leuprolide doses of 7.5 mg monthly.
Report a problemFND-1903585804
05HumanRandomized controlled trialEfficacy outcome
In prostate cancer patients, testosterone suppression at 3 days occurred in 96.1% with degarelix 240/80 mg versus none with leuprolide.
In plain wordsIn prostate cancer patients, testosterone suppression at 3 days occurred in 96.1% with degarelix 240/80 mg versus none with leuprolide.
Peptide
Degarelix
Outcome
IncreaseTestosterone suppression at 3 days
Study
n: not reported in source
Comparator
leuprolide
Outcome group
Sex hormones and fertility · Endocrine and hormones
Studied dose
240/80 mg · subcutaneous · 3 daysAs given in this study (human).
Measurements
Patients with testosterone <=0.5 ng/mL at 3 days
96.1%
degarelix 240/80 mg
Patients with testosterone <=0.5 ng/mL at 3 days
0%
leuprolide ('none')
Source sentences
Summary
At 3 days after starting treatment, testosterone levels were <or=0.5 ng/mL in 96.1% and 95.5% of patients in the degarelix 240/80 mg and 240/160 mg groups, respectively, and in none in the leuprolide group.
2 context sentences(design, population, supporting numbers)
Summary · context
In all, 610 patients with adenocarcinoma of the prostate (any stage; median age 72 years; median testosterone 3.93 ng/mL, median prostate-specific antigen, PSA, level 19.0 ng/mL) were randomized and received study treatment.
Summary · context
Three dosing regimens were evaluated: a starting dose of 240 mg of degarelix subcutaneous (s.c.) for 1 month, followed by s.c. maintenance doses of 80 mg or 160 mg monthly, or intramuscular (i.m.) leuprolide doses of 7.5 mg monthly.
Report a problemFND-1903585805
06HumanRandomized controlled trialEfficacy outcome
In prostate cancer patients, testosterone suppression at 3 days occurred in 95.5% with degarelix 240/160 mg versus none with leuprolide.
In plain wordsIn prostate cancer patients, testosterone suppression at 3 days occurred in 95.5% with degarelix 240/160 mg versus none with leuprolide.
Peptide
Degarelix
Outcome
IncreaseTestosterone suppression at 3 days
Study
n: not reported in source
Comparator
leuprolide
Outcome group
Sex hormones and fertility · Endocrine and hormones
Studied dose
240/160 mg · subcutaneous · 3 daysAs given in this study (human).
Measurements
Patients with testosterone <=0.5 ng/mL at 3 days
95.5%
degarelix 240/160 mg
Patients with testosterone <=0.5 ng/mL at 3 days
0%
leuprolide ('none')
Source sentences
Summary
At 3 days after starting treatment, testosterone levels were <or=0.5 ng/mL in 96.1% and 95.5% of patients in the degarelix 240/80 mg and 240/160 mg groups, respectively, and in none in the leuprolide group.
2 context sentences(design, population, supporting numbers)
Summary · context
In all, 610 patients with adenocarcinoma of the prostate (any stage; median age 72 years; median testosterone 3.93 ng/mL, median prostate-specific antigen, PSA, level 19.0 ng/mL) were randomized and received study treatment.
Summary · context
Three dosing regimens were evaluated: a starting dose of 240 mg of degarelix subcutaneous (s.c.) for 1 month, followed by s.c. maintenance doses of 80 mg or 160 mg monthly, or intramuscular (i.m.) leuprolide doses of 7.5 mg monthly.
Report a problemFND-1903585806
07HumanRandomized controlled trialEfficacy outcome
In prostate cancer patients, none receiving leuprolide had testosterone at or below 0.5 ng/mL at 3 days, versus 96.1% with degarelix 240/80 mg.
In plain wordsIn prostate cancer patients, none on leuprolide had testosterone of 0.5 ng/mL or lower at 3 days, versus 96.1% on degarelix 240/80 mg.
Peptide
Leuprolide
Outcome
DecreaseTestosterone at or below 0.5 ng/mL at day 3 versus degarelix 240/80 mg
Study
n: not reported in source
Comparator
degarelix 240/80 mg
Outcome group
Sex hormones and fertility · Endocrine and hormones
Studied dose
7.5 mg monthly · intramuscular · 12 monthsAs given in this study (human).
Measurements
Testosterone <=0.5 ng/mL at day 3
0%
leuprolide 7.5 mg group
Testosterone <=0.5 ng/mL at day 3
96.1%
degarelix 240/80 mg group
Source sentences
Summary
At 3 days after starting treatment, testosterone levels were <or=0.5 ng/mL in 96.1% and 95.5% of patients in the degarelix 240/80 mg and 240/160 mg groups, respectively, and in none in the leuprolide group.
2 context sentences(design, population, supporting numbers)
Summary · context
In all, 610 patients with adenocarcinoma of the prostate (any stage; median age 72 years; median testosterone 3.93 ng/mL, median prostate-specific antigen, PSA, level 19.0 ng/mL) were randomized and received study treatment.
Summary · context
Three dosing regimens were evaluated: a starting dose of 240 mg of degarelix subcutaneous (s.c.) for 1 month, followed by s.c. maintenance doses of 80 mg or 160 mg monthly, or intramuscular (i.m.) leuprolide doses of 7.5 mg monthly.
Report a problemFND-1903585807
08HumanRandomized controlled trialEfficacy outcome
In prostate cancer patients, none receiving leuprolide had testosterone at or below 0.5 ng/mL at 3 days, versus 95.5% with degarelix 240/160 mg.
In plain wordsIn prostate cancer patients, none on leuprolide had testosterone of 0.5 ng/mL or lower at 3 days, versus 95.5% on degarelix 240/160 mg.
Peptide
Leuprolide
Outcome
DecreaseTestosterone at or below 0.5 ng/mL at day 3 versus degarelix 240/160 mg
Study
n: not reported in source
Comparator
degarelix 240/160 mg
Outcome group
Sex hormones and fertility · Endocrine and hormones
Studied dose
7.5 mg monthly · intramuscular · 12 monthsAs given in this study (human).
Measurements
Testosterone <=0.5 ng/mL at day 3
0%
leuprolide 7.5 mg group
Testosterone <=0.5 ng/mL at day 3
95.5%
degarelix 240/160 mg group
Source sentences
Summary
At 3 days after starting treatment, testosterone levels were <or=0.5 ng/mL in 96.1% and 95.5% of patients in the degarelix 240/80 mg and 240/160 mg groups, respectively, and in none in the leuprolide group.
2 context sentences(design, population, supporting numbers)
Summary · context
In all, 610 patients with adenocarcinoma of the prostate (any stage; median age 72 years; median testosterone 3.93 ng/mL, median prostate-specific antigen, PSA, level 19.0 ng/mL) were randomized and received study treatment.
Summary · context
Three dosing regimens were evaluated: a starting dose of 240 mg of degarelix subcutaneous (s.c.) for 1 month, followed by s.c. maintenance doses of 80 mg or 160 mg monthly, or intramuscular (i.m.) leuprolide doses of 7.5 mg monthly.
Report a problemFND-1903585808
09HumanRandomized controlled trialEfficacy outcome
In prostate cancer patients, median PSA at 14 days was significantly lower with degarelix than leuprolide.
In plain wordsIn prostate cancer patients, median PSA at 14 days was lower with degarelix than leuprolide.
Peptide
Degarelix
Outcome
DecreasePSA at 14 days
Study
n: not reported in source
Comparator
leuprolide
Outcome group
Tumor growth · Cancer
Studied dose
240 mg initial, then 80 or 160 mg monthly · subcutaneous · 12 monthsAs given in this study (human).
Measurements
P value
< 0.001 unitless
median PSA at 14 days, degarelix groups versus leuprolide group
Source sentences
Summary
The median PSA levels at 14 and 28 days were significantly lower in the degarelix groups than in the leuprolide group (P < 0.001).
2 context sentences(design, population, supporting numbers)
Summary · context
In all, 610 patients with adenocarcinoma of the prostate (any stage; median age 72 years; median testosterone 3.93 ng/mL, median prostate-specific antigen, PSA, level 19.0 ng/mL) were randomized and received study treatment.
Summary · context
Three dosing regimens were evaluated: a starting dose of 240 mg of degarelix subcutaneous (s.c.) for 1 month, followed by s.c. maintenance doses of 80 mg or 160 mg monthly, or intramuscular (i.m.) leuprolide doses of 7.5 mg monthly.
Report a problemFND-1903585809
10HumanRandomized controlled trialEfficacy outcome
In prostate cancer patients, median PSA at 28 days was significantly lower with degarelix than leuprolide.
In plain wordsIn prostate cancer patients, median PSA at 28 days was lower with degarelix than leuprolide.
Peptide
Degarelix
Outcome
DecreasePSA at 28 days
Study
n: not reported in source
Comparator
leuprolide
Outcome group
Tumor growth · Cancer
Studied dose
240 mg initial, then 80 or 160 mg monthly · subcutaneous · 12 monthsAs given in this study (human).
Measurements
P value
< 0.001 unitless
median PSA at 28 days, degarelix groups versus leuprolide group
Source sentences
Summary
The median PSA levels at 14 and 28 days were significantly lower in the degarelix groups than in the leuprolide group (P < 0.001).
2 context sentences(design, population, supporting numbers)
Summary · context
In all, 610 patients with adenocarcinoma of the prostate (any stage; median age 72 years; median testosterone 3.93 ng/mL, median prostate-specific antigen, PSA, level 19.0 ng/mL) were randomized and received study treatment.
Summary · context
Three dosing regimens were evaluated: a starting dose of 240 mg of degarelix subcutaneous (s.c.) for 1 month, followed by s.c. maintenance doses of 80 mg or 160 mg monthly, or intramuscular (i.m.) leuprolide doses of 7.5 mg monthly.
Report a problemFND-1903585810
11HumanRandomized controlled trialEfficacy outcome
In prostate cancer patients, median PSA at 14 days was significantly higher with leuprolide than degarelix.
In plain wordsIn prostate cancer patients, median PSA at 14 days was higher with leuprolide than degarelix.
Peptide
Leuprolide
Outcome
IncreasePSA at 14 days
Study
n: not reported in source
Comparator
degarelix
Outcome group
Tumor growth · Cancer
Studied dose
7.5 mg monthly · intramuscular · 12 monthsAs given in this study (human).
Measurements
P value
< 0.001 unitless
median PSA at 14 days, degarelix groups versus leuprolide group
Source sentences
Summary
The median PSA levels at 14 and 28 days were significantly lower in the degarelix groups than in the leuprolide group (P < 0.001).
2 context sentences(design, population, supporting numbers)
Summary · context
In all, 610 patients with adenocarcinoma of the prostate (any stage; median age 72 years; median testosterone 3.93 ng/mL, median prostate-specific antigen, PSA, level 19.0 ng/mL) were randomized and received study treatment.
Summary · context
Three dosing regimens were evaluated: a starting dose of 240 mg of degarelix subcutaneous (s.c.) for 1 month, followed by s.c. maintenance doses of 80 mg or 160 mg monthly, or intramuscular (i.m.) leuprolide doses of 7.5 mg monthly.
Report a problemFND-1903585811
12HumanRandomized controlled trialEfficacy outcome
In prostate cancer patients, median PSA at 28 days was significantly higher with leuprolide than degarelix.
In plain wordsIn prostate cancer patients, median PSA at 28 days was higher with leuprolide than degarelix.
Peptide
Leuprolide
Outcome
IncreasePSA at 28 days
Study
n: not reported in source
Comparator
degarelix
Outcome group
Tumor growth · Cancer
Studied dose
7.5 mg monthly · intramuscular · 12 monthsAs given in this study (human).
Measurements
P value
< 0.001 unitless
median PSA at 28 days, degarelix groups versus leuprolide group
Source sentences
Summary
The median PSA levels at 14 and 28 days were significantly lower in the degarelix groups than in the leuprolide group (P < 0.001).
2 context sentences(design, population, supporting numbers)
Summary · context
In all, 610 patients with adenocarcinoma of the prostate (any stage; median age 72 years; median testosterone 3.93 ng/mL, median prostate-specific antigen, PSA, level 19.0 ng/mL) were randomized and received study treatment.
Summary · context
Three dosing regimens were evaluated: a starting dose of 240 mg of degarelix subcutaneous (s.c.) for 1 month, followed by s.c. maintenance doses of 80 mg or 160 mg monthly, or intramuscular (i.m.) leuprolide doses of 7.5 mg monthly.
Report a problemFND-1903585812
13HumanRandomized controlled trialSafety outcome
In prostate cancer patients, injection-site reactions were higher with degarelix than leuprolide, 40% versus <1%.
In plain wordsIn prostate cancer patients, injection-site reactions were higher with degarelix than leuprolide, 40% versus <1%.
Peptide
Degarelix
Outcome
IncreaseInjection-site reactions
Study
n: not reported in source
Comparator
leuprolide
Outcome group
Adverse events · Skin and wound
Studied dose
240 mg initial, then 80 or 160 mg monthly · subcutaneous · 12 monthsAs given in this study (human).
Measurements
Injection-site reactions rate
40%
degarelix s.c. group
Injection-site reactions rate
< 1%
leuprolide i.m. group
P value
< 0.001 unitless
injection-site reactions, degarelix versus leuprolide
Source sentences
Summary
The s.c. degarelix injection was associated with a higher rate of injection-site reactions than with the i.m. leuprolide injection (40% vs <1%; P < 0.001, respectively).
2 context sentences(design, population, supporting numbers)
Summary · context
In all, 610 patients with adenocarcinoma of the prostate (any stage; median age 72 years; median testosterone 3.93 ng/mL, median prostate-specific antigen, PSA, level 19.0 ng/mL) were randomized and received study treatment.
Summary · context
Three dosing regimens were evaluated: a starting dose of 240 mg of degarelix subcutaneous (s.c.) for 1 month, followed by s.c. maintenance doses of 80 mg or 160 mg monthly, or intramuscular (i.m.) leuprolide doses of 7.5 mg monthly.
Report a problemFND-1903585815
14HumanRandomized controlled trialSafety outcome
In prostate cancer patients, injection-site reactions were lower with leuprolide than degarelix, <1% versus 40%.
In plain wordsIn prostate cancer patients, injection-site reactions were lower with leuprolide than degarelix, <1% versus 40%.
Peptide
Leuprolide
Outcome
DecreaseInjection-site reactions
Study
n: not reported in source
Comparator
degarelix
Outcome group
Adverse events · Skin and wound
Studied dose
7.5 mg monthly · intramuscular · 12 monthsAs given in this study (human).
Measurements
Injection-site reactions rate
< 1%
leuprolide i.m. group
Injection-site reactions rate
40%
degarelix s.c. group
P value
< 0.001 unitless
injection-site reactions, degarelix versus leuprolide
Source sentences
Summary
The s.c. degarelix injection was associated with a higher rate of injection-site reactions than with the i.m. leuprolide injection (40% vs <1%; P < 0.001, respectively).
2 context sentences(design, population, supporting numbers)
Summary · context
In all, 610 patients with adenocarcinoma of the prostate (any stage; median age 72 years; median testosterone 3.93 ng/mL, median prostate-specific antigen, PSA, level 19.0 ng/mL) were randomized and received study treatment.
Summary · context
Three dosing regimens were evaluated: a starting dose of 240 mg of degarelix subcutaneous (s.c.) for 1 month, followed by s.c. maintenance doses of 80 mg or 160 mg monthly, or intramuscular (i.m.) leuprolide doses of 7.5 mg monthly.
Report a problemFND-1903585816
15HumanRandomized controlled trialSafety outcome
In prostate cancer patients, urinary tract infections occurred in 3% with degarelix versus 9% with leuprolide.
In plain wordsIn prostate cancer patients, urinary tract infections occurred in 3% with degarelix versus 9% with leuprolide.
Peptide
Degarelix
Outcome
DecreaseUrinary tract infections
Study
n: not reported in source
Comparator
leuprolide
Outcome group
Adverse events · Kidney and urinary
Studied dose
240 mg initial, then 80 or 160 mg monthly · subcutaneous · 12 monthsAs given in this study (human).
Measurements
Urinary tract infections rate
3%
degarelix group
Urinary tract infections rate
9%
leuprolide group
P value
< 0.01 unitless
urinary tract infections, degarelix versus leuprolide
Source sentences
Summary
There were additional differences between the degarelix and leuprolide groups for urinary tract infections (3% vs 9%. P < 0.01, respectively), arthralgia (4% vs 9%, P < 0.05, respectively) and chills (4% vs 0%, P < 0.01, respectively).
2 context sentences(design, population, supporting numbers)
Summary · context
In all, 610 patients with adenocarcinoma of the prostate (any stage; median age 72 years; median testosterone 3.93 ng/mL, median prostate-specific antigen, PSA, level 19.0 ng/mL) were randomized and received study treatment.
Summary · context
Three dosing regimens were evaluated: a starting dose of 240 mg of degarelix subcutaneous (s.c.) for 1 month, followed by s.c. maintenance doses of 80 mg or 160 mg monthly, or intramuscular (i.m.) leuprolide doses of 7.5 mg monthly.
Report a problemFND-1903585817
16HumanRandomized controlled trialSafety outcome
In prostate cancer patients, urinary tract infections occurred in 9% with leuprolide versus 3% with degarelix.
In plain wordsIn prostate cancer patients, urinary tract infections occurred in 9% with leuprolide versus 3% with degarelix.
Peptide
Leuprolide
Outcome
IncreaseUrinary tract infections
Study
n: not reported in source
Comparator
degarelix
Outcome group
Adverse events · Kidney and urinary
Studied dose
7.5 mg monthly · intramuscular · 12 monthsAs given in this study (human).
Measurements
Urinary tract infections rate
3%
degarelix group
Urinary tract infections rate
9%
leuprolide group
P value
< 0.01 unitless
urinary tract infections, degarelix versus leuprolide
Source sentences
Summary
There were additional differences between the degarelix and leuprolide groups for urinary tract infections (3% vs 9%. P < 0.01, respectively), arthralgia (4% vs 9%, P < 0.05, respectively) and chills (4% vs 0%, P < 0.01, respectively).
2 context sentences(design, population, supporting numbers)
Summary · context
In all, 610 patients with adenocarcinoma of the prostate (any stage; median age 72 years; median testosterone 3.93 ng/mL, median prostate-specific antigen, PSA, level 19.0 ng/mL) were randomized and received study treatment.
Summary · context
Three dosing regimens were evaluated: a starting dose of 240 mg of degarelix subcutaneous (s.c.) for 1 month, followed by s.c. maintenance doses of 80 mg or 160 mg monthly, or intramuscular (i.m.) leuprolide doses of 7.5 mg monthly.
Report a problemFND-1903585818
17HumanRandomized controlled trialSafety outcome
In prostate cancer patients, arthralgia occurred in 4% with degarelix versus 9% with leuprolide.
In plain wordsIn prostate cancer patients, arthralgia occurred in 4% with degarelix versus 9% with leuprolide.
Peptide
Degarelix
Outcome
DecreaseArthralgia
Study
n: not reported in source
Comparator
leuprolide
Outcome group
Adverse events · Musculoskeletal
Studied dose
240 mg initial, then 80 or 160 mg monthly · subcutaneous · 12 monthsAs given in this study (human).
Measurements
Arthralgia rate
4%
degarelix group
Arthralgia rate
9%
leuprolide group
P value
< 0.05 unitless
arthralgia, degarelix versus leuprolide
Source sentences
Summary
There were additional differences between the degarelix and leuprolide groups for urinary tract infections (3% vs 9%. P < 0.01, respectively), arthralgia (4% vs 9%, P < 0.05, respectively) and chills (4% vs 0%, P < 0.01, respectively).
2 context sentences(design, population, supporting numbers)
Summary · context
In all, 610 patients with adenocarcinoma of the prostate (any stage; median age 72 years; median testosterone 3.93 ng/mL, median prostate-specific antigen, PSA, level 19.0 ng/mL) were randomized and received study treatment.
Summary · context
Three dosing regimens were evaluated: a starting dose of 240 mg of degarelix subcutaneous (s.c.) for 1 month, followed by s.c. maintenance doses of 80 mg or 160 mg monthly, or intramuscular (i.m.) leuprolide doses of 7.5 mg monthly.
Report a problemFND-1903585819
18HumanRandomized controlled trialSafety outcome
In prostate cancer patients, arthralgia occurred in 9% with leuprolide versus 4% with degarelix.
In plain wordsIn prostate cancer patients, arthralgia occurred in 9% with leuprolide versus 4% with degarelix.
Peptide
Leuprolide
Outcome
IncreaseArthralgia
Study
n: not reported in source
Comparator
degarelix
Outcome group
Adverse events · Musculoskeletal
Studied dose
7.5 mg monthly · intramuscular · 12 monthsAs given in this study (human).
Measurements
Arthralgia rate
4%
degarelix group
Arthralgia rate
9%
leuprolide group
P value
< 0.05 unitless
arthralgia, degarelix versus leuprolide
Source sentences
Summary
There were additional differences between the degarelix and leuprolide groups for urinary tract infections (3% vs 9%. P < 0.01, respectively), arthralgia (4% vs 9%, P < 0.05, respectively) and chills (4% vs 0%, P < 0.01, respectively).
2 context sentences(design, population, supporting numbers)
Summary · context
In all, 610 patients with adenocarcinoma of the prostate (any stage; median age 72 years; median testosterone 3.93 ng/mL, median prostate-specific antigen, PSA, level 19.0 ng/mL) were randomized and received study treatment.
Summary · context
Three dosing regimens were evaluated: a starting dose of 240 mg of degarelix subcutaneous (s.c.) for 1 month, followed by s.c. maintenance doses of 80 mg or 160 mg monthly, or intramuscular (i.m.) leuprolide doses of 7.5 mg monthly.
Report a problemFND-1903585820
19HumanRandomized controlled trialSafety outcome
In prostate cancer patients, chills occurred in 4% with degarelix versus 0% with leuprolide.
In plain wordsIn prostate cancer patients, chills occurred in 4% with degarelix versus 0% with leuprolide.
Peptide
Degarelix
Outcome
IncreaseChills
Study
n: not reported in source
Comparator
leuprolide
Outcome group
Adverse events · Whole body
Studied dose
240 mg initial, then 80 or 160 mg monthly · subcutaneous · 12 monthsAs given in this study (human).
Measurements
Chills rate
4%
degarelix group
Chills rate
0%
leuprolide group
P value
< 0.01 unitless
chills, degarelix versus leuprolide
Source sentences
Summary
There were additional differences between the degarelix and leuprolide groups for urinary tract infections (3% vs 9%. P < 0.01, respectively), arthralgia (4% vs 9%, P < 0.05, respectively) and chills (4% vs 0%, P < 0.01, respectively).
2 context sentences(design, population, supporting numbers)
Summary · context
In all, 610 patients with adenocarcinoma of the prostate (any stage; median age 72 years; median testosterone 3.93 ng/mL, median prostate-specific antigen, PSA, level 19.0 ng/mL) were randomized and received study treatment.
Summary · context
Three dosing regimens were evaluated: a starting dose of 240 mg of degarelix subcutaneous (s.c.) for 1 month, followed by s.c. maintenance doses of 80 mg or 160 mg monthly, or intramuscular (i.m.) leuprolide doses of 7.5 mg monthly.
Report a problemFND-1903585821
20HumanRandomized controlled trialSafety outcome
In prostate cancer patients, chills occurred in 0% with leuprolide versus 4% with degarelix.
In plain wordsIn prostate cancer patients, chills occurred in 0% with leuprolide versus 4% with degarelix.
Peptide
Leuprolide
Outcome
DecreaseChills
Study
n: not reported in source
Comparator
degarelix
Outcome group
Adverse events · Whole body
Studied dose
7.5 mg monthly · intramuscular · 12 monthsAs given in this study (human).
Measurements
Chills rate
4%
degarelix group
Chills rate
0%
leuprolide group
P value
< 0.01 unitless
chills, degarelix versus leuprolide
Source sentences
Summary
There were additional differences between the degarelix and leuprolide groups for urinary tract infections (3% vs 9%. P < 0.01, respectively), arthralgia (4% vs 9%, P < 0.05, respectively) and chills (4% vs 0%, P < 0.01, respectively).
2 context sentences(design, population, supporting numbers)
Summary · context
In all, 610 patients with adenocarcinoma of the prostate (any stage; median age 72 years; median testosterone 3.93 ng/mL, median prostate-specific antigen, PSA, level 19.0 ng/mL) were randomized and received study treatment.
Summary · context
Three dosing regimens were evaluated: a starting dose of 240 mg of degarelix subcutaneous (s.c.) for 1 month, followed by s.c. maintenance doses of 80 mg or 160 mg monthly, or intramuscular (i.m.) leuprolide doses of 7.5 mg monthly.
Report a problemFND-1903585822
21HumanNon-randomized trialSafety outcome
In prostate cancer patients, degarelix hormonal side effects resembled previously reported androgen-deprivation therapy effects.
In plain wordsIn prostate cancer patients, degarelix hormonal side effects resembled previously reported androgen-deprivation therapy effects.
Peptide
Degarelix
Outcome
Direction not reportedHormonal side-effect profile
Study
n: not reported in source
Comparator
previously reported androgen-deprivation therapy effects
Outcome group
Adverse events · Whole body
Studied dose
240 mg initial, then 80 or 160 mg monthly · subcutaneous · 12 monthsAs given in this study (human).
Source sentences
Summary
The hormonal side-effect profiles of the three treatment groups were similar to previously reported effects for androgen-deprivation therapy.
2 context sentences(design, population, supporting numbers)
Summary · context
In all, 610 patients with adenocarcinoma of the prostate (any stage; median age 72 years; median testosterone 3.93 ng/mL, median prostate-specific antigen, PSA, level 19.0 ng/mL) were randomized and received study treatment.
Summary · context
Three dosing regimens were evaluated: a starting dose of 240 mg of degarelix subcutaneous (s.c.) for 1 month, followed by s.c. maintenance doses of 80 mg or 160 mg monthly, or intramuscular (i.m.) leuprolide doses of 7.5 mg monthly.
Report a problemFND-1903585813
22HumanNon-randomized trialSafety outcome
In prostate cancer patients, leuprolide hormonal side effects resembled previously reported androgen-deprivation therapy effects.
In plain wordsIn prostate cancer patients, leuprolide hormonal side effects resembled previously reported androgen-deprivation therapy effects.
Peptide
Leuprolide
Outcome
Direction not reportedHormonal side-effect profile
Study
n: not reported in source
Comparator
previously reported androgen-deprivation therapy effects
Outcome group
Adverse events · Whole body
Studied dose
7.5 mg monthly · intramuscular · 12 monthsAs given in this study (human).
Source sentences
Summary
The hormonal side-effect profiles of the three treatment groups were similar to previously reported effects for androgen-deprivation therapy.
2 context sentences(design, population, supporting numbers)
Summary · context
In all, 610 patients with adenocarcinoma of the prostate (any stage; median age 72 years; median testosterone 3.93 ng/mL, median prostate-specific antigen, PSA, level 19.0 ng/mL) were randomized and received study treatment.
Summary · context
Three dosing regimens were evaluated: a starting dose of 240 mg of degarelix subcutaneous (s.c.) for 1 month, followed by s.c. maintenance doses of 80 mg or 160 mg monthly, or intramuscular (i.m.) leuprolide doses of 7.5 mg monthly.
Report a problemFND-1903585814
23HumanNon-randomized trialSafety outcome
In prostate cancer patients receiving degarelix, no systemic allergic reactions occurred.
In plain wordsIn prostate cancer patients receiving degarelix, no systemic allergic reactions occurred.
Peptide
Degarelix
Outcome
Direction not reportedSystemic allergic reactions
Study
n: not reported in source
Outcome group
Adverse events · Immune and inflammation
Studied dose
240 mg initial, then 80 or 160 mg monthly · subcutaneous · 12 monthsAs given in this study (human).
Source sentences
Summary
There were no systemic allergic reactions.
2 context sentences(design, population, supporting numbers)
Summary · context
In all, 610 patients with adenocarcinoma of the prostate (any stage; median age 72 years; median testosterone 3.93 ng/mL, median prostate-specific antigen, PSA, level 19.0 ng/mL) were randomized and received study treatment.
Summary · context
Three dosing regimens were evaluated: a starting dose of 240 mg of degarelix subcutaneous (s.c.) for 1 month, followed by s.c. maintenance doses of 80 mg or 160 mg monthly, or intramuscular (i.m.) leuprolide doses of 7.5 mg monthly.
Report a problemFND-1903585823
24HumanNon-randomized trialSafety outcome
In prostate cancer patients receiving leuprolide, no systemic allergic reactions occurred.
In plain wordsIn prostate cancer patients receiving leuprolide, no systemic allergic reactions occurred.
Peptide
Leuprolide
Outcome
Direction not reportedSystemic allergic reactions
Study
n: not reported in source
Outcome group
Adverse events · Immune and inflammation
Studied dose
7.5 mg monthly · intramuscular · 12 monthsAs given in this study (human).
Source sentences
Summary
There were no systemic allergic reactions.
2 context sentences(design, population, supporting numbers)
Summary · context
In all, 610 patients with adenocarcinoma of the prostate (any stage; median age 72 years; median testosterone 3.93 ng/mL, median prostate-specific antigen, PSA, level 19.0 ng/mL) were randomized and received study treatment.
Summary · context
Three dosing regimens were evaluated: a starting dose of 240 mg of degarelix subcutaneous (s.c.) for 1 month, followed by s.c. maintenance doses of 80 mg or 160 mg monthly, or intramuscular (i.m.) leuprolide doses of 7.5 mg monthly.
Report a problemFND-1903585824

AI wrote and checked these results. AI can make mistakes, so check important results against the source.

Registered trials2

Trials this study reports on, or that list this study as a reference. Registry data from ClinicalTrials.gov.

2 trials · 2 completed · 1 with posted results · source ClinicalTrials.gov (opens in a new tab)

CompletedPhase not statedNCT01710098

Treatment of Prostate Cancer With Firmagon®

United Clinic Management GmbHn = 100Jun 2012 to 24 Sept 2015

Prostate Cancer

Trial page ClinicalTrials.govUpdated 13 Apr 2020

CompletedPhase 3Results postedNCT00295750

The Efficacy and Safety of Degarelix One Month Dosing Regimens in Prostate Cancer

Ferring Pharmaceuticalsn = 620Feb 2006 to Oct 2007

Prostate Cancer

Trial page ClinicalTrials.govUpdated 19 Dec 2012

Version history

PepBank keeps every version of the data on this study. Status changes from Retraction Watch, Europe PMC and Crossref are listed with their source.

Version 3Current
28 Oct 2026, 02:03 UTC
Study results updated
Version 2
27 Oct 2026, 16:37 UTC
Study data updated · source update from Europe PMC
Version 1
27 Oct 2026, 16:34 UTC
First added · source update from Europe PMC

Subjects

Terms as the source lists them.

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