Skip to content

Study · Randomized controlled trial · n = 234 · 2018

11 results

Efficacy and safety of 3-month dosing regimen of degarelix in Japanese subjects with prostate cancer: A phase III study.

Ozono S, Tsukamoto T, Naito S, Horie S, Ohashi Y, Uemura H, Yokomizo Y, Fukasawa S, Kusuoka H, Akazawa R, Saito M, Akaza H

Cancer science23 May 2018Cited by 19 (Europe PMC)

PMID29624800 (opens in a new tab)PMCIDPMC5989846 (opens in a new tab)DOI10.1111/cas.13600 (opens in a new tab)PepBankPUB-29624800
Read at sourcePubMedAsk about this study
Jump to 11 results

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. Results still quote short attributed sentences.

Results from this study11

11 results from studies that gave the peptide. 11 results from people.

  1. 01HumanRandomized controlled trialEfficacy outcome

    In Japanese prostate cancer patients, the cumulative castration rate was 95.1% with degarelix versus 100.0% with goserelin, meeting non-inferiority.

    In plain wordsIn Japanese prostate cancer patients, degarelix was non-inferior to goserelin for castration rate.

    Peptide
    Degarelix
    Outcome
    Not applicableCumulative castration rate
    Study

    n = 234

    Comparator
    Goserelin
    Analysis
    Primary
    Outcome group
    Sex hormones and fertility · Endocrine and hormones
    Studied dose
    240 mg initially, then 480 mg every 84 days after day 28 · subcutaneous · day 28 to day 364As given in this study (human).

    Measurements

    Castration rate
    95.1%
    degarelix
    Castration rate
    100%
    goserelin

    Source sentences

    Summary
    The cumulative castration rate was 95.1% in the degarelix group and 100.0% in the goserelin group.
    5 context sentences
    Summary · context
    Analyses indicated the non-inferiority of the 3-month formulation of degarelix to goserelin.
    Summary · context
    The primary end-point was the cumulative castration rate from day 28 to day 364 and the non-inferiority margin was set to be 10%.
    Summary · context
    A phase III, open-label, parallel-arm study was carried out.
    Summary · context
    An initial dose of 240 mg degarelix or 3.6 mg goserelin was given s.c.; after day 28, a maintenance dose of 480 mg degarelix or 10.8 mg goserelin was given once every 84 days.
    Summary · context
    A total of 234 subjects with prostate cancer were randomized to the degarelix group (n = 117) and the goserelin group (n = 117).
  2. 02HumanRandomized controlled trialEfficacy outcome

    In Japanese prostate cancer patients, cumulative castration rates were 100.0% with goserelin and 95.1% with degarelix, which met non-inferiority.

    In plain wordsIn Japanese prostate cancer patients, castration rates were 100.0% with goserelin and 95.1% with degarelix, which met non-inferiority.

    Peptide
    Goserelin
    Outcome
    Not applicableCumulative castration rate
    Study

    n = 234

    Comparator
    Degarelix
    Analysis
    Primary
    Outcome group
    Sex hormones and fertility · Endocrine and hormones
    Studied dose
    3.6 mg initially, then 10.8 mg every 84 days after day 28 · subcutaneous · day 28 to day 364As given in this study (human).

    Measurements

    Castration rate
    100%
    goserelin
    Castration rate
    95.1%
    degarelix

    Source sentences

    Summary
    The cumulative castration rate was 95.1% in the degarelix group and 100.0% in the goserelin group.
    5 context sentences
    Summary · context
    Analyses indicated the non-inferiority of the 3-month formulation of degarelix to goserelin.
    Summary · context
    The primary end-point was the cumulative castration rate from day 28 to day 364 and the non-inferiority margin was set to be 10%.
    Summary · context
    A phase III, open-label, parallel-arm study was carried out.
    Summary · context
    An initial dose of 240 mg degarelix or 3.6 mg goserelin was given s.c.; after day 28, a maintenance dose of 480 mg degarelix or 10.8 mg goserelin was given once every 84 days.
    Summary · context
    A total of 234 subjects with prostate cancer were randomized to the degarelix group (n = 117) and the goserelin group (n = 117).
  3. 03HumanRandomized controlled trialEfficacy outcome

    In Japanese prostate cancer patients, testosterone decreased more rapidly with degarelix than goserelin.

    In plain wordsIn Japanese prostate cancer patients, testosterone decreased faster with degarelix than goserelin.

    Peptide
    Degarelix
    Outcome
    IncreaseTestosterone suppression speed
    Study

    n = 234

    Comparator
    Goserelin
    Outcome group
    Sex hormones and fertility · Endocrine and hormones
    Studied dose
    240 mg initially, then 480 mg every 84 days after day 28 · subcutaneousAs given in this study (human).

    Source sentences

    Summary
    Degarelix showed more rapid decreases in testosterone, luteinizing hormone, follicle stimulating hormone, and prostate-specific antigen levels compared with goserelin.
    3 context sentences
    Summary · context
    A phase III, open-label, parallel-arm study was carried out.
    Summary · context
    An initial dose of 240 mg degarelix or 3.6 mg goserelin was given s.c.; after day 28, a maintenance dose of 480 mg degarelix or 10.8 mg goserelin was given once every 84 days.
    Summary · context
    A total of 234 subjects with prostate cancer were randomized to the degarelix group (n = 117) and the goserelin group (n = 117).
  4. 04HumanRandomized controlled trialEfficacy outcome

    In Japanese prostate cancer patients, testosterone decreased less rapidly with goserelin than degarelix.

    In plain wordsIn Japanese prostate cancer patients, testosterone decreased more slowly with goserelin than degarelix.

    Peptide
    Goserelin
    Outcome
    DecreaseTestosterone suppression speed
    Study

    n = 234

    Comparator
    Degarelix
    Outcome group
    Sex hormones and fertility · Endocrine and hormones
    Studied dose
    3.6 mg initially, then 10.8 mg every 84 days after day 28 · subcutaneousAs given in this study (human).

    Source sentences

    Summary
    Degarelix showed more rapid decreases in testosterone, luteinizing hormone, follicle stimulating hormone, and prostate-specific antigen levels compared with goserelin.
    3 context sentences
    Summary · context
    A phase III, open-label, parallel-arm study was carried out.
    Summary · context
    An initial dose of 240 mg degarelix or 3.6 mg goserelin was given s.c.; after day 28, a maintenance dose of 480 mg degarelix or 10.8 mg goserelin was given once every 84 days.
    Summary · context
    A total of 234 subjects with prostate cancer were randomized to the degarelix group (n = 117) and the goserelin group (n = 117).
  5. 05HumanRandomized controlled trialEfficacy outcome

    In Japanese prostate cancer patients, luteinizing hormone decreased more rapidly with degarelix than goserelin.

    In plain wordsIn Japanese prostate cancer patients, luteinizing hormone decreased faster with degarelix than goserelin.

    Peptide
    Degarelix
    Outcome
    IncreaseLuteinizing hormone suppression speed
    Study

    n = 234

    Comparator
    Goserelin
    Outcome group
    Sex hormones and fertility · Endocrine and hormones
    Studied dose
    240 mg initially, then 480 mg every 84 days after day 28 · subcutaneousAs given in this study (human).

    Source sentences

    Summary
    Degarelix showed more rapid decreases in testosterone, luteinizing hormone, follicle stimulating hormone, and prostate-specific antigen levels compared with goserelin.
    3 context sentences
    Summary · context
    A phase III, open-label, parallel-arm study was carried out.
    Summary · context
    An initial dose of 240 mg degarelix or 3.6 mg goserelin was given s.c.; after day 28, a maintenance dose of 480 mg degarelix or 10.8 mg goserelin was given once every 84 days.
    Summary · context
    A total of 234 subjects with prostate cancer were randomized to the degarelix group (n = 117) and the goserelin group (n = 117).
  6. 06HumanRandomized controlled trialEfficacy outcome

    In Japanese prostate cancer patients, luteinizing hormone decreased less rapidly with goserelin than degarelix.

    In plain wordsIn Japanese prostate cancer patients, luteinizing hormone decreased more slowly with goserelin than degarelix.

    Peptide
    Goserelin
    Outcome
    DecreaseLuteinizing hormone suppression speed
    Study

    n = 234

    Comparator
    Degarelix
    Outcome group
    Sex hormones and fertility · Endocrine and hormones
    Studied dose
    3.6 mg initially, then 10.8 mg every 84 days after day 28 · subcutaneousAs given in this study (human).

    Source sentences

    Summary
    Degarelix showed more rapid decreases in testosterone, luteinizing hormone, follicle stimulating hormone, and prostate-specific antigen levels compared with goserelin.
    3 context sentences
    Summary · context
    A phase III, open-label, parallel-arm study was carried out.
    Summary · context
    An initial dose of 240 mg degarelix or 3.6 mg goserelin was given s.c.; after day 28, a maintenance dose of 480 mg degarelix or 10.8 mg goserelin was given once every 84 days.
    Summary · context
    A total of 234 subjects with prostate cancer were randomized to the degarelix group (n = 117) and the goserelin group (n = 117).
  7. 07HumanRandomized controlled trialEfficacy outcome

    In Japanese prostate cancer patients, follicle-stimulating hormone decreased more rapidly with degarelix than goserelin.

    In plain wordsIn Japanese prostate cancer patients, follicle-stimulating hormone decreased faster with degarelix than goserelin.

    Peptide
    Degarelix
    Outcome
    IncreaseFollicle-stimulating hormone suppression speed
    Study

    n = 234

    Comparator
    Goserelin
    Outcome group
    Sex hormones and fertility · Endocrine and hormones
    Studied dose
    240 mg initially, then 480 mg every 84 days after day 28 · subcutaneousAs given in this study (human).

    Source sentences

    Summary
    Degarelix showed more rapid decreases in testosterone, luteinizing hormone, follicle stimulating hormone, and prostate-specific antigen levels compared with goserelin.
    3 context sentences
    Summary · context
    A phase III, open-label, parallel-arm study was carried out.
    Summary · context
    An initial dose of 240 mg degarelix or 3.6 mg goserelin was given s.c.; after day 28, a maintenance dose of 480 mg degarelix or 10.8 mg goserelin was given once every 84 days.
    Summary · context
    A total of 234 subjects with prostate cancer were randomized to the degarelix group (n = 117) and the goserelin group (n = 117).
  8. 08HumanRandomized controlled trialEfficacy outcome

    In Japanese prostate cancer patients, follicle-stimulating hormone decreased less rapidly with goserelin than degarelix.

    In plain wordsIn Japanese prostate cancer patients, follicle-stimulating hormone decreased more slowly with goserelin than degarelix.

    Peptide
    Goserelin
    Outcome
    DecreaseFollicle-stimulating hormone suppression speed
    Study

    n = 234

    Comparator
    Degarelix
    Outcome group
    Sex hormones and fertility · Endocrine and hormones
    Studied dose
    3.6 mg initially, then 10.8 mg every 84 days after day 28 · subcutaneousAs given in this study (human).

    Source sentences

    Summary
    Degarelix showed more rapid decreases in testosterone, luteinizing hormone, follicle stimulating hormone, and prostate-specific antigen levels compared with goserelin.
    3 context sentences
    Summary · context
    A phase III, open-label, parallel-arm study was carried out.
    Summary · context
    An initial dose of 240 mg degarelix or 3.6 mg goserelin was given s.c.; after day 28, a maintenance dose of 480 mg degarelix or 10.8 mg goserelin was given once every 84 days.
    Summary · context
    A total of 234 subjects with prostate cancer were randomized to the degarelix group (n = 117) and the goserelin group (n = 117).
  9. 09HumanRandomized controlled trialEfficacy outcome

    In Japanese prostate cancer patients, PSA decreased more rapidly with degarelix than goserelin.

    In plain wordsIn Japanese prostate cancer patients, PSA decreased faster with degarelix than goserelin.

    Peptide
    Degarelix
    Outcome
    IncreasePSA suppression speed
    Study

    n = 234

    Comparator
    Goserelin
    Outcome group
    Tumor growth · Cancer
    Studied dose
    240 mg initially, then 480 mg every 84 days after day 28 · subcutaneousAs given in this study (human).

    Source sentences

    Summary
    Degarelix showed more rapid decreases in testosterone, luteinizing hormone, follicle stimulating hormone, and prostate-specific antigen levels compared with goserelin.
    3 context sentences
    Summary · context
    A phase III, open-label, parallel-arm study was carried out.
    Summary · context
    An initial dose of 240 mg degarelix or 3.6 mg goserelin was given s.c.; after day 28, a maintenance dose of 480 mg degarelix or 10.8 mg goserelin was given once every 84 days.
    Summary · context
    A total of 234 subjects with prostate cancer were randomized to the degarelix group (n = 117) and the goserelin group (n = 117).
  10. 10HumanRandomized controlled trialEfficacy outcome

    In Japanese prostate cancer patients, PSA decreased less rapidly with goserelin than degarelix.

    In plain wordsIn Japanese prostate cancer patients, PSA decreased more slowly with goserelin than degarelix.

    Peptide
    Goserelin
    Outcome
    DecreasePSA suppression speed
    Study

    n = 234

    Comparator
    Degarelix
    Outcome group
    Tumor growth · Cancer
    Studied dose
    3.6 mg initially, then 10.8 mg every 84 days after day 28 · subcutaneousAs given in this study (human).

    Source sentences

    Summary
    Degarelix showed more rapid decreases in testosterone, luteinizing hormone, follicle stimulating hormone, and prostate-specific antigen levels compared with goserelin.
    3 context sentences
    Summary · context
    A phase III, open-label, parallel-arm study was carried out.
    Summary · context
    An initial dose of 240 mg degarelix or 3.6 mg goserelin was given s.c.; after day 28, a maintenance dose of 480 mg degarelix or 10.8 mg goserelin was given once every 84 days.
    Summary · context
    A total of 234 subjects with prostate cancer were randomized to the degarelix group (n = 117) and the goserelin group (n = 117).
  11. 11HumanNon-randomized trialSafety outcome

    In Japanese prostate cancer patients, injection site reactions were the most common adverse events with degarelix.

    In plain wordsIn Japanese prostate cancer patients, injection site reactions were the most common adverse events with degarelix.

    Peptide
    Degarelix
    Outcome
    Not applicableInjection site reactions
    Study

    n = 117

    Outcome group
    Adverse events · Skin and wound
    Studied dose
    240 mg initially, then 480 mg every 84 days after day 28 · subcutaneousAs given in this study (human).

    Source sentences

    Summary
    The most common adverse events in the degarelix group were injection site reactions.
    3 context sentences
    Summary · context
    A phase III, open-label, parallel-arm study was carried out.
    Summary · context
    An initial dose of 240 mg degarelix or 3.6 mg goserelin was given s.c.; after day 28, a maintenance dose of 480 mg degarelix or 10.8 mg goserelin was given once every 84 days.
    Summary · context
    A total of 234 subjects with prostate cancer were randomized to the degarelix group (n = 117) and the goserelin group (n = 117).

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

Registered trials1

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

1 trial · 1 completed · source ClinicalTrials.gov (opens in a new tab)

CompletedPhase 3NCT01964170

A Study to Compare the Effect of ASP3550 With Goserelin in Patients With Prostate Cancer

Astellas Pharma Incn = 23413 Aug 2013 to 8 Aug 2016

Prostate Cancer

Trial pageClinicalTrials.govUpdated 31 Oct 2024

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.

  1. Version 3Current

    28 Oct 2026, 02:03 UTC

    Study results updated

  2. Version 2

    27 Oct 2026, 16:35 UTC

    Study data updated · source update from Europe PMC

  3. Version 1

    27 Oct 2026, 16:34 UTC

    First added · source update from Europe PMC

Subjects

Terms as the source lists them.

PepBank is a research reference. Talk to a doctor before you use any peptide.