The efficacy and safety of degarelix, a GnRH antagonist: a 12-month, multicentre, randomized, maintenance dose-finding phase II study in Japanese patients with prostate cancer.

Ozono S, Ueda T, Hoshi S, Yamaguchi A, Maeda H, Fukuyama Y, Takeda K, Ohashi Y, Tsukamoto T, Naito S, Akaza H

Japanese journal of clinical oncology28 Mar 2012Cited by 28 (Europe PMC)

PMID22457321DOI10.1093/jjco/hys035PepBankPUB-22457321

Publisher page PubMedAsk about this study

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: Publisher copyright. Results still quote short attributed sentences.

Results from this study13

13 results from studies that gave the peptide. 13 results from people.

01HumanNon-randomized trialEfficacy outcome
In Japanese prostate cancer patients, PSA decreased rapidly after degarelix and remained low throughout the study.
In plain wordsIn Japanese prostate cancer patients, PSA decreased rapidly after degarelix and remained low throughout the study.
Peptide
Degarelix
Outcome
DecreasePSA reduction
Study
n = 273
Outcome group
Tumor growth · Cancer
Studied dose
240 mg initial, then 80 or 160 mg monthly · subcutaneous · 12 monthsAs given in this study (human).
Source sentences
Summary
Prostate-specific antigen levels decreased rapidly following degarelix administration and remained low throughout the study.
3 context sentences(design, population, supporting numbers)
Summary · context
This Phase II study was conducted as a multicentre, randomized, parallel-group, open-label study.
Summary · context
A total of 273 patients with adenocarcinoma of the prostate (any stage) were treated.
Summary · context
Degarelix was administered subcutaneously at an initial dose of 240 mg followed by monthly maintenance doses of either 80 or 160 mg for a total of 12 doses.
Report a problemFND-2245732105
02HumanNon-randomized trialSafety outcome
In Japanese prostate cancer patients receiving degarelix, 18 patients (6.6%) withdrew due to adverse events.
In plain wordsIn Japanese prostate cancer patients receiving degarelix, 6.6% withdrew due to adverse events.
Peptide
Degarelix
Outcome
Not applicableWithdrawal due to adverse events
Study
n = 273
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
Adverse event withdrawals
18 patients
study population
Adverse event withdrawals
6.6%
study population
Source sentences
Summary
Eighteen patients (6.6%) withdrew from the study due to adverse events.
3 context sentences(design, population, supporting numbers)
Summary · context
This Phase II study was conducted as a multicentre, randomized, parallel-group, open-label study.
Summary · context
A total of 273 patients with adenocarcinoma of the prostate (any stage) were treated.
Summary · context
Degarelix was administered subcutaneously at an initial dose of 240 mg followed by monthly maintenance doses of either 80 or 160 mg for a total of 12 doses.
Report a problemFND-2245732108
03HumanNon-randomized trialSafety outcome
In Japanese prostate cancer patients receiving degarelix, injection site reactions were the most common adverse events.
In plain wordsIn Japanese prostate cancer patients receiving degarelix, injection site reactions were the most common adverse events.
Peptide
Degarelix
Outcome
Not applicableInjection site reactions
Study
n = 273
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).
Source sentences
Summary
The most common adverse events were injection site reactions; other adverse events included hot flush, nasopharyngitis, weight increase and pyrexia.
3 context sentences(design, population, supporting numbers)
Summary · context
This Phase II study was conducted as a multicentre, randomized, parallel-group, open-label study.
Summary · context
A total of 273 patients with adenocarcinoma of the prostate (any stage) were treated.
Summary · context
Degarelix was administered subcutaneously at an initial dose of 240 mg followed by monthly maintenance doses of either 80 or 160 mg for a total of 12 doses.
Report a problemFND-2245732109
04HumanNon-randomized trialSafety outcome
In Japanese prostate cancer patients receiving degarelix, adverse events included hot flush.
In plain wordsIn Japanese prostate cancer patients receiving degarelix, adverse events included hot flush.
Peptide
Degarelix
Outcome
Not applicableHot flush
Study
n = 273
Outcome group
Adverse events · Endocrine and hormones
Studied dose
240 mg initial, then 80 or 160 mg monthly · subcutaneous · 12 monthsAs given in this study (human).
Source sentences
Summary
The most common adverse events were injection site reactions; other adverse events included hot flush, nasopharyngitis, weight increase and pyrexia.
3 context sentences(design, population, supporting numbers)
Summary · context
This Phase II study was conducted as a multicentre, randomized, parallel-group, open-label study.
Summary · context
A total of 273 patients with adenocarcinoma of the prostate (any stage) were treated.
Summary · context
Degarelix was administered subcutaneously at an initial dose of 240 mg followed by monthly maintenance doses of either 80 or 160 mg for a total of 12 doses.
Report a problemFND-2245732110
05HumanNon-randomized trialSafety outcome
In Japanese prostate cancer patients receiving degarelix, adverse events included nasopharyngitis.
In plain wordsIn Japanese prostate cancer patients receiving degarelix, adverse events included inflammation of the nose and throat.
Peptide
Degarelix
Outcome
Not applicableNasopharyngitis
Study
n = 273
Outcome group
Adverse events · Infection
Studied dose
240 mg initial, then 80 or 160 mg monthly · subcutaneous · 12 monthsAs given in this study (human).
Source sentences
Summary
The most common adverse events were injection site reactions; other adverse events included hot flush, nasopharyngitis, weight increase and pyrexia.
3 context sentences(design, population, supporting numbers)
Summary · context
This Phase II study was conducted as a multicentre, randomized, parallel-group, open-label study.
Summary · context
A total of 273 patients with adenocarcinoma of the prostate (any stage) were treated.
Summary · context
Degarelix was administered subcutaneously at an initial dose of 240 mg followed by monthly maintenance doses of either 80 or 160 mg for a total of 12 doses.
Report a problemFND-2245732111
06HumanNon-randomized trialSafety outcome
In Japanese prostate cancer patients receiving degarelix, adverse events included weight increase.
In plain wordsIn Japanese prostate cancer patients receiving degarelix, adverse events included weight increase.
Peptide
Degarelix
Outcome
IncreaseWeight increase
Study
n = 273
Outcome group
Body weight · Metabolic and weight
Studied dose
240 mg initial, then 80 or 160 mg monthly · subcutaneous · 12 monthsAs given in this study (human).
Source sentences
Summary
The most common adverse events were injection site reactions; other adverse events included hot flush, nasopharyngitis, weight increase and pyrexia.
3 context sentences(design, population, supporting numbers)
Summary · context
This Phase II study was conducted as a multicentre, randomized, parallel-group, open-label study.
Summary · context
A total of 273 patients with adenocarcinoma of the prostate (any stage) were treated.
Summary · context
Degarelix was administered subcutaneously at an initial dose of 240 mg followed by monthly maintenance doses of either 80 or 160 mg for a total of 12 doses.
Report a problemFND-2245732112
07HumanNon-randomized trialSafety outcome
In Japanese prostate cancer patients receiving degarelix, adverse events included pyrexia.
In plain wordsIn Japanese prostate cancer patients receiving degarelix, adverse events included fever.
Peptide
Degarelix
Outcome
Not applicablePyrexia
Study
n = 273
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 most common adverse events were injection site reactions; other adverse events included hot flush, nasopharyngitis, weight increase and pyrexia.
3 context sentences(design, population, supporting numbers)
Summary · context
This Phase II study was conducted as a multicentre, randomized, parallel-group, open-label study.
Summary · context
A total of 273 patients with adenocarcinoma of the prostate (any stage) were treated.
Summary · context
Degarelix was administered subcutaneously at an initial dose of 240 mg followed by monthly maintenance doses of either 80 or 160 mg for a total of 12 doses.
Report a problemFND-2245732113
08HumanNon-randomized trialEfficacy outcome
In Japanese prostate cancer patients, RECIST best overall response with degarelix 240/80 mg was 71.4% (20/28).
In plain wordsIn Japanese prostate cancer patients, the lower degarelix maintenance regimen produced tumor responses in 20 of 28 evaluated patients.
Peptide
Degarelix
Outcome
Not applicableRECIST best overall response
Study
n = 28
Outcome group
Tumor growth · Cancer
Studied dose
240/80 mg · subcutaneous · 12 monthsAs given in this study (human).
Measurements
Best overall response
71.4%
20/28, 240/80 mg
Source sentences
Summary
Best overall response rates according to RECIST were 71.4 (20/28) and 72.7% (16/22), respectively.
4 context sentences(design, population, supporting numbers)
Summary · context
Dose regimens of 240/80 and 240/160 mg maintained castrate levels of testosterone in 94.5 and 95.2% of the patients, respectively.
Summary · context
This Phase II study was conducted as a multicentre, randomized, parallel-group, open-label study.
Summary · context
A total of 273 patients with adenocarcinoma of the prostate (any stage) were treated.
Summary · context
Degarelix was administered subcutaneously at an initial dose of 240 mg followed by monthly maintenance doses of either 80 or 160 mg for a total of 12 doses.
Report a problemFND-2245732106
09HumanNon-randomized trialEfficacy outcome
In Japanese prostate cancer patients, RECIST best overall response with degarelix 240/160 mg was 72.7% (16/22).
In plain wordsIn Japanese prostate cancer patients, the higher degarelix maintenance regimen produced tumor responses in 16 of 22 evaluated patients.
Peptide
Degarelix
Outcome
Not applicableRECIST best overall response
Study
n = 22
Outcome group
Tumor growth · Cancer
Studied dose
240/160 mg · subcutaneous · 12 monthsAs given in this study (human).
Measurements
Best overall response
72.7%
16/22, 240/160 mg
Source sentences
Summary
Best overall response rates according to RECIST were 71.4 (20/28) and 72.7% (16/22), respectively.
4 context sentences(design, population, supporting numbers)
Summary · context
Dose regimens of 240/80 and 240/160 mg maintained castrate levels of testosterone in 94.5 and 95.2% of the patients, respectively.
Summary · context
This Phase II study was conducted as a multicentre, randomized, parallel-group, open-label study.
Summary · context
A total of 273 patients with adenocarcinoma of the prostate (any stage) were treated.
Summary · context
Degarelix was administered subcutaneously at an initial dose of 240 mg followed by monthly maintenance doses of either 80 or 160 mg for a total of 12 doses.
Report a problemFND-2245732107
10HumanNon-randomized trialEfficacy outcome
In Japanese prostate cancer patients, degarelix 240/80 mg maintained castrate testosterone in 94.5%.
In plain wordsIn Japanese prostate cancer patients, degarelix 240/80 mg maintained very low testosterone in 94.5%.
Peptide
Degarelix
Outcome
Not applicableMaintenance of castrate testosterone
Study
n: not reported in source
Outcome group
Sex hormones and fertility · Endocrine and hormones
Studied dose
240/80 mg · subcutaneous · 12 monthsAs given in this study (human).
Measurements
Castrate testosterone maintenance
94.5%
240/80 mg
Source sentences
Summary
Dose regimens of 240/80 and 240/160 mg maintained castrate levels of testosterone in 94.5 and 95.2% of the patients, respectively.
3 context sentences(design, population, supporting numbers)
Summary · context
This Phase II study was conducted as a multicentre, randomized, parallel-group, open-label study.
Summary · context
A total of 273 patients with adenocarcinoma of the prostate (any stage) were treated.
Summary · context
Degarelix was administered subcutaneously at an initial dose of 240 mg followed by monthly maintenance doses of either 80 or 160 mg for a total of 12 doses.
Report a problemFND-2245732101
11HumanNon-randomized trialEfficacy outcome
In Japanese prostate cancer patients, degarelix 240/160 mg maintained castrate testosterone in 95.2%.
In plain wordsIn Japanese prostate cancer patients, degarelix 240/160 mg maintained very low testosterone in 95.2%.
Peptide
Degarelix
Outcome
Not applicableMaintenance of castrate testosterone
Study
n: not reported in source
Outcome group
Sex hormones and fertility · Endocrine and hormones
Studied dose
240/160 mg · subcutaneous · 12 monthsAs given in this study (human).
Measurements
Castrate testosterone maintenance
95.2%
240/160 mg
Source sentences
Summary
Dose regimens of 240/80 and 240/160 mg maintained castrate levels of testosterone in 94.5 and 95.2% of the patients, respectively.
3 context sentences(design, population, supporting numbers)
Summary · context
This Phase II study was conducted as a multicentre, randomized, parallel-group, open-label study.
Summary · context
A total of 273 patients with adenocarcinoma of the prostate (any stage) were treated.
Summary · context
Degarelix was administered subcutaneously at an initial dose of 240 mg followed by monthly maintenance doses of either 80 or 160 mg for a total of 12 doses.
Report a problemFND-2245732102
12HumanNon-randomized trialEfficacy outcome
In Japanese prostate cancer patients, 99.3% on degarelix 240/80 mg reached castrate testosterone after 3 days without a testosterone surge.
In plain wordsIn Japanese prostate cancer patients, 99.3% on the lower maintenance regimen reached very low testosterone after 3 days without a surge.
Peptide
Degarelix
Outcome
Not applicableCastrate testosterone at day three without surge
Study
n: not reported in source
Outcome group
Sex hormones and fertility · Endocrine and hormones
Studied dose
240/80 mg · subcutaneous · 12 monthsAs given in this study (human).
Measurements
Castrate testosterone without surge
99.3%
day 3, 240/80 mg
Source sentences
Summary
After 3 days, 99.3 and 98.5% of the patients, respectively, reached these levels without a testosterone surge.
4 context sentences(design, population, supporting numbers)
Summary · context
Dose regimens of 240/80 and 240/160 mg maintained castrate levels of testosterone in 94.5 and 95.2% of the patients, respectively.
Summary · context
This Phase II study was conducted as a multicentre, randomized, parallel-group, open-label study.
Summary · context
A total of 273 patients with adenocarcinoma of the prostate (any stage) were treated.
Summary · context
Degarelix was administered subcutaneously at an initial dose of 240 mg followed by monthly maintenance doses of either 80 or 160 mg for a total of 12 doses.
Report a problemFND-2245732103
13HumanNon-randomized trialEfficacy outcome
In Japanese prostate cancer patients, 98.5% on degarelix 240/160 mg reached castrate testosterone after 3 days without a testosterone surge.
In plain wordsIn Japanese prostate cancer patients, 98.5% on the higher maintenance regimen reached very low testosterone after 3 days without a surge.
Peptide
Degarelix
Outcome
Not applicableCastrate testosterone at day three without surge
Study
n: not reported in source
Outcome group
Sex hormones and fertility · Endocrine and hormones
Studied dose
240/160 mg · subcutaneous · 12 monthsAs given in this study (human).
Measurements
Castrate testosterone without surge
98.5%
day 3, 240/160 mg
Source sentences
Summary
After 3 days, 99.3 and 98.5% of the patients, respectively, reached these levels without a testosterone surge.
4 context sentences(design, population, supporting numbers)
Summary · context
Dose regimens of 240/80 and 240/160 mg maintained castrate levels of testosterone in 94.5 and 95.2% of the patients, respectively.
Summary · context
This Phase II study was conducted as a multicentre, randomized, parallel-group, open-label study.
Summary · context
A total of 273 patients with adenocarcinoma of the prostate (any stage) were treated.
Summary · context
Degarelix was administered subcutaneously at an initial dose of 240 mg followed by monthly maintenance doses of either 80 or 160 mg for a total of 12 doses.
Report a problemFND-2245732104

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

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 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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The efficacy and safety of degarelix, a GnRH antagonist: a 12-month, multicentre, randomized, maintenance dose-finding phase II study in Japanese patients with prostate cancer.

Summary

Results from this study13

Version history

Subjects

Publication types

MeSH terms