Efficacy and safety of degarelix in Korean patients with prostate cancer requiring androgen deprivation therapy: Open-label multicenter phase III study.

You D, Chung BH, Lee SE, Kim CS

Prostate international12 Feb 2015Cited by 2 (Europe PMC)

PMID26157762PMCIDPMC4494635DOI10.1016/j.prnil.2015.02.005PepBankPUB-26157762

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Summary

The text of this summary is not shown here, because the article license does not allow reuse. Read it at the source (opens in a new tab)

Text rights: CC BY-NC-ND. Results still quote short attributed sentences.

Results from this study9

9 results from studies that gave the peptide. 9 results from people.

01HumanNon-randomized trialEfficacy outcome
In Korean prostate cancer patients, cumulative testosterone suppression probability was 96.7% versus 99.0% in non-Asian patients, a -2.3% difference.
In plain wordsIn prostate cancer patients receiving degarelix, cumulative testosterone suppression was 96.7% in Korean patients versus 99.0% in non-Asian patients.
Peptide
Degarelix
Outcome
Not applicableCumulative testosterone suppression
Study
n: not reported in source
Comparator
Non-Asian degarelix recipients in CS21
Outcome group
Sex hormones and fertility · Endocrine and hormones
Studied dose
240 mg starting dose, then 80 mg every 28 days · 7 monthsAs given in this study (human).
Measurements
Cumulative probability of testosterone <=0.5 ng/mL, Day 28-196
96.7%
CS42 Korean patients
Cumulative probability of testosterone <=0.5 ng/mL, Day 28-196
99%
CS21 non-Asian patients
Estimated difference
−2.3%
CS42 vs CS21
Source sentences
Summary
The estimated difference in the cumulative probabilities of testosterone ≤0.5 ng/mL from Day 28 to Day 196 between the trials was -2.3% (96.7% in CS42 vs. 99.0% in CS21).
3 context sentences(design, population, supporting numbers)
Summary · context
A Phase III, open-label, multicenter, single-arm trial was conducted in Korean patients with PCa.
Summary · context
Degarelix was administered at a starting dose of 240 mg followed by monthly (28-day intervals) maintenance doses of 80 mg (240/80 mg dose regimen) for 7 months.
Summary · context
The results were compared with non-Asian patients receiving degarelix 240/80 mg in the CS21 study.
Report a problemFND-2615776201
02HumanNon-randomized trialEfficacy outcome
In Korean prostate cancer patients, degarelix testosterone suppression met noninferiority against non-Asian patients, with a lower confidence limit of -5.5%.
In plain wordsIn prostate cancer patients, testosterone suppression with degarelix in Korean patients met noninferiority against non-Asian patients.
Peptide
Degarelix
Outcome
Not applicableTestosterone suppression noninferiority
Study
n: not reported in source
Comparator
Non-Asian degarelix recipients in CS21
Outcome group
Sex hormones and fertility · Endocrine and hormones
Studied dose
240 mg starting dose, then 80 mg every 28 days · 7 monthsAs given in this study (human).
Measurements
Lower limit of 95% CI for difference
−5.5%
CS42 vs CS21
Noninferiority limit
−10%
predefined
Source sentences
Summary
The lower limit of the 95% confidence interval was -5.5%, i.e., above the predefined noninferiority limit of -10% and thus noninferiority was established.
3 context sentences(design, population, supporting numbers)
Summary · context
A Phase III, open-label, multicenter, single-arm trial was conducted in Korean patients with PCa.
Summary · context
Degarelix was administered at a starting dose of 240 mg followed by monthly (28-day intervals) maintenance doses of 80 mg (240/80 mg dose regimen) for 7 months.
Summary · context
The results were compared with non-Asian patients receiving degarelix 240/80 mg in the CS21 study.
Report a problemFND-2615776202
03HumanNon-randomized trialEfficacy outcome
In prostate cancer patients receiving degarelix, testosterone decreases were similar in Korean and non-Asian trials.
In plain wordsIn prostate cancer patients receiving degarelix, testosterone decreases were similar in Korean and non-Asian trials.
Peptide
Degarelix
Outcome
Not applicableSerum testosterone decrease
Study
n: not reported in source
Comparator
Non-Asian degarelix recipients in CS21
Outcome group
Sex hormones and fertility · Endocrine and hormones
Studied dose
240 mg starting dose, then 80 mg every 28 days · 7 monthsAs given in this study (human).
Source sentences
Summary
Decreases in serum testosterone, prostate-specific antigen, and luteinizing hormone over time were similar in CS42 and CS21.
3 context sentences(design, population, supporting numbers)
Summary · context
A Phase III, open-label, multicenter, single-arm trial was conducted in Korean patients with PCa.
Summary · context
Degarelix was administered at a starting dose of 240 mg followed by monthly (28-day intervals) maintenance doses of 80 mg (240/80 mg dose regimen) for 7 months.
Summary · context
The results were compared with non-Asian patients receiving degarelix 240/80 mg in the CS21 study.
Report a problemFND-2615776203
04HumanNon-randomized trialEfficacy outcome
In prostate cancer patients receiving degarelix, PSA decreases were similar in Korean and non-Asian trials.
In plain wordsIn prostate cancer patients receiving degarelix, PSA decreases were similar in Korean and non-Asian trials.
Peptide
Degarelix
Outcome
Not applicablePSA decrease
Study
n: not reported in source
Comparator
Non-Asian degarelix recipients in CS21
Outcome group
Tumor growth · Cancer
Studied dose
240 mg starting dose, then 80 mg every 28 days · 7 monthsAs given in this study (human).
Source sentences
Summary
Decreases in serum testosterone, prostate-specific antigen, and luteinizing hormone over time were similar in CS42 and CS21.
3 context sentences(design, population, supporting numbers)
Summary · context
A Phase III, open-label, multicenter, single-arm trial was conducted in Korean patients with PCa.
Summary · context
Degarelix was administered at a starting dose of 240 mg followed by monthly (28-day intervals) maintenance doses of 80 mg (240/80 mg dose regimen) for 7 months.
Summary · context
The results were compared with non-Asian patients receiving degarelix 240/80 mg in the CS21 study.
Report a problemFND-2615776204
05HumanNon-randomized trialEfficacy outcome
In prostate cancer patients receiving degarelix, luteinizing hormone decreases were similar in Korean and non-Asian trials.
In plain wordsIn prostate cancer patients receiving degarelix, luteinizing hormone decreases were similar in Korean and non-Asian trials.
Peptide
Degarelix
Outcome
Not applicableLuteinizing hormone decrease
Study
n: not reported in source
Comparator
Non-Asian degarelix recipients in CS21
Outcome group
Sex hormones and fertility · Endocrine and hormones
Studied dose
240 mg starting dose, then 80 mg every 28 days · 7 monthsAs given in this study (human).
Source sentences
Summary
Decreases in serum testosterone, prostate-specific antigen, and luteinizing hormone over time were similar in CS42 and CS21.
3 context sentences(design, population, supporting numbers)
Summary · context
A Phase III, open-label, multicenter, single-arm trial was conducted in Korean patients with PCa.
Summary · context
Degarelix was administered at a starting dose of 240 mg followed by monthly (28-day intervals) maintenance doses of 80 mg (240/80 mg dose regimen) for 7 months.
Summary · context
The results were compared with non-Asian patients receiving degarelix 240/80 mg in the CS21 study.
Report a problemFND-2615776205
06HumanNon-randomized trialSafety outcome
In prostate cancer patients receiving degarelix, treatment-emergent adverse events occurred in 72% of Korean versus 70% of non-Asian patients without clinically significant differences.
In plain wordsIn prostate cancer patients receiving degarelix, adverse-event incidence did not differ clinically between Korean and non-Asian trials.
Peptide
Degarelix
Outcome
Not applicableTreatment-emergent adverse events
Study
n: not reported in source
Comparator
Non-Asian degarelix recipients in CS21
Outcome group
Adverse events · Whole body
Studied dose
240 mg starting dose, then 80 mg every 28 days · 7 monthsAs given in this study (human).
Measurements
Treatment-emergent adverse events
72%
CS42 Korean patients
Treatment-emergent adverse events
70%
CS21 non-Asian patients
Source sentences
Summary
There were no clinically significant differences in incidence of treatment-emergent adverse events (72% in CS42 vs. 70% in CS21) and changes in clinical chemistry and hematology parameters between the two trials.
3 context sentences(design, population, supporting numbers)
Summary · context
A Phase III, open-label, multicenter, single-arm trial was conducted in Korean patients with PCa.
Summary · context
Degarelix was administered at a starting dose of 240 mg followed by monthly (28-day intervals) maintenance doses of 80 mg (240/80 mg dose regimen) for 7 months.
Summary · context
The results were compared with non-Asian patients receiving degarelix 240/80 mg in the CS21 study.
Report a problemFND-2615776206
07HumanNon-randomized trialSafety outcome
In prostate cancer patients receiving degarelix, clinical chemistry changes did not differ clinically between Korean and non-Asian trials.
In plain wordsIn prostate cancer patients receiving degarelix, clinical chemistry changes did not differ clinically between Korean and non-Asian trials.
Peptide
Degarelix
Outcome
Not applicableClinical chemistry changes
Study
n: not reported in source
Comparator
Non-Asian degarelix recipients in CS21
Outcome group
Adverse events · Whole body
Studied dose
240 mg starting dose, then 80 mg every 28 days · 7 monthsAs given in this study (human).
Source sentences
Summary
There were no clinically significant differences in incidence of treatment-emergent adverse events (72% in CS42 vs. 70% in CS21) and changes in clinical chemistry and hematology parameters between the two trials.
3 context sentences(design, population, supporting numbers)
Summary · context
A Phase III, open-label, multicenter, single-arm trial was conducted in Korean patients with PCa.
Summary · context
Degarelix was administered at a starting dose of 240 mg followed by monthly (28-day intervals) maintenance doses of 80 mg (240/80 mg dose regimen) for 7 months.
Summary · context
The results were compared with non-Asian patients receiving degarelix 240/80 mg in the CS21 study.
Report a problemFND-2615776207
08HumanNon-randomized trialSafety outcome
In prostate cancer patients receiving degarelix, hematology changes did not differ clinically between Korean and non-Asian trials.
In plain wordsIn prostate cancer patients receiving degarelix, hematology changes did not differ clinically between Korean and non-Asian trials.
Peptide
Degarelix
Outcome
Not applicableHematology changes
Study
n: not reported in source
Comparator
Non-Asian degarelix recipients in CS21
Outcome group
Adverse events · Whole body
Studied dose
240 mg starting dose, then 80 mg every 28 days · 7 monthsAs given in this study (human).
Source sentences
Summary
There were no clinically significant differences in incidence of treatment-emergent adverse events (72% in CS42 vs. 70% in CS21) and changes in clinical chemistry and hematology parameters between the two trials.
3 context sentences(design, population, supporting numbers)
Summary · context
A Phase III, open-label, multicenter, single-arm trial was conducted in Korean patients with PCa.
Summary · context
Degarelix was administered at a starting dose of 240 mg followed by monthly (28-day intervals) maintenance doses of 80 mg (240/80 mg dose regimen) for 7 months.
Summary · context
The results were compared with non-Asian patients receiving degarelix 240/80 mg in the CS21 study.
Report a problemFND-2615776208
09HumanNon-randomized trialSafety outcome
In Korean prostate cancer patients receiving degarelix, injection-site reaction was the most common adverse event.
In plain wordsIn Korean prostate cancer patients receiving degarelix, injection-site reaction was the most common adverse event.
Peptide
Degarelix
Outcome
Not applicableInjection-site reaction
Study
n: not reported in source
Outcome group
Adverse events · Skin and wound
Studied dose
240 mg starting dose, then 80 mg every 28 days · 7 monthsAs given in this study (human).
Source sentences
Summary
The most common adverse event was injection-site reaction.
3 context sentences(design, population, supporting numbers)
Summary · context
A Phase III, open-label, multicenter, single-arm trial was conducted in Korean patients with PCa.
Summary · context
Degarelix was administered at a starting dose of 240 mg followed by monthly (28-day intervals) maintenance doses of 80 mg (240/80 mg dose regimen) for 7 months.
Summary · context
The results were compared with non-Asian patients receiving degarelix 240/80 mg in the CS21 study.
Report a problemFND-2615776209

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

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