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Study · Randomized controlled trial · n = 175 · 2012

4 results

Androgen deprivation therapy for volume reduction, lower urinary tract symptom relief and quality of life improvement in patients with prostate cancer: degarelix vs goserelin plus bicalutamide.

Axcrona K, Aaltomaa S, da Silva CM, Ozen H, Damber JE, Tankó LB, Colli E, Klarskov P

BJU international13 Apr 2012Cited by 81 (Europe PMC)

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 study4

4 results from studies that gave the peptide. 4 results from people.

  1. 01HumanRandomized controlled trialEfficacy outcome

    In prostate cancer patients, prostate volume changes were similar with degarelix and goserelin plus bicalutamide (-37.2% versus -39.0%), meeting non-inferiority.

    In plain wordsIn prostate cancer patients, prostate volume reductions were similar with degarelix and goserelin plus bicalutamide.

    Peptide
    Degarelix
    Outcome
    No significant changeTotal prostate volume change
    Study

    n = 175

    Comparator
    Goserelin plus initial bicalutamide
    Analysis
    Primary
    Outcome group
    Tumor growth · Kidney and urinary
    Studied dose
    240/80 mg monthly · 12 weeksAs given in this study (human).

    Measurements

    Prostate volume change
    −37.2%
    degarelix
    Prostate volume change
    −39%
    goserelin

    Source sentences

    Summary
    At week 12, changes in TPV for degarelix and goserelin were similar (-37.2% vs -39.0%) and met the predefined non-inferiority criterion.
    1 context sentence
    Summary · context
    • This was a randomized, parallel-arm, active-controlled, open-label, multicentre trial on 182 patients treated with either monthly degarelix (240/80 mg) or goserelin (3.6 mg) for 12 weeks. • For flare protection, goserelin-treated patients also received daily bicalutamide (50 mg) during the initial 28 days.
  2. 02HumanRandomized controlled trialEfficacy outcome

    In prostate cancer patients, IPSS responses occurred in 61.0% with degarelix versus 44.3% with goserelin plus bicalutamide (P = 0.02).

    In plain wordsIn prostate cancer patients, more patients had urinary symptom responses with degarelix than goserelin plus bicalutamide.

    Peptide
    Degarelix
    Outcome
    IncreaseIPSS change of at least three points
    Study

    n = 175

    Comparator
    Goserelin plus initial bicalutamide
    Outcome group
    Urinary continence and bladder function · Kidney and urinary
    Studied dose
    240/80 mg monthly · 12 weeksAs given in this study (human).

    Measurements

    IPSS response
    61%
    degarelix
    IPSS response
    44.3%
    goserelin

    Source sentences

    Summary
    The number of patients with an IPSS change of ≥ 3 over baseline was also significantly higher in patients treated with degarelix (61.0 vs 44.3%, P = 0.02).
    1 context sentence
    Summary · context
    • This was a randomized, parallel-arm, active-controlled, open-label, multicentre trial on 182 patients treated with either monthly degarelix (240/80 mg) or goserelin (3.6 mg) for 12 weeks. • For flare protection, goserelin-treated patients also received daily bicalutamide (50 mg) during the initial 28 days.
  3. 03HumanRandomized controlled trialEfficacy outcome

    In symptomatic prostate cancer patients, IPSS fell more with degarelix than goserelin plus bicalutamide (-6.7 ± 1.8 versus -4.0 ± 1.0; P = 0.02).

    In plain wordsIn symptomatic prostate cancer patients, degarelix reduced urinary symptoms more than goserelin plus bicalutamide.

    Peptide
    Degarelix
    Outcome
    DecreaseIPSS decrease with baseline IPSS above thirteen
    Study

    n: not reported in source

    Comparator
    Goserelin plus initial bicalutamide
    Outcome group
    Urinary continence and bladder function · Kidney and urinary
    Studied dose
    240/80 mg monthly · 12 weeksAs given in this study (human).

    Measurements

    IPSS change
    −6.7 points
    degarelix, baseline IPSS > 13
    IPSS change
    −4 points
    goserelin, baseline IPSS > 13

    Source sentences

    Summary
    Decreases in IPSS were greater in degarelix than in goserelin-treated patients, differences being statistically significant in patients with baseline IPSS > 13 (-6.7 ± 1.8 vs -4.0 ± 1.0; P = 0.02).
    1 context sentence
    Summary · context
    • This was a randomized, parallel-arm, active-controlled, open-label, multicentre trial on 182 patients treated with either monthly degarelix (240/80 mg) or goserelin (3.6 mg) for 12 weeks. • For flare protection, goserelin-treated patients also received daily bicalutamide (50 mg) during the initial 28 days.
  4. 04HumanRandomized controlled trialSafety outcome

    In prostate cancer patients, degarelix and goserelin plus bicalutamide were both reported as safe and well tolerated.

    In plain wordsIn prostate cancer patients, degarelix and goserelin plus bicalutamide were both reported as safe and well tolerated.

    Peptide
    Degarelix
    Outcome
    Not applicableSafety and tolerability
    Study

    n: not reported in source

    Comparator
    Goserelin plus initial bicalutamide
    Outcome group
    Adverse events · Whole body
    Studied dose
    240/80 mg monthly · 12 weeksAs given in this study (human).

    Source sentences

    Summary
    Both treatments were safe and well tolerated.
    1 context sentence
    Summary · context
    • This was a randomized, parallel-arm, active-controlled, open-label, multicentre trial on 182 patients treated with either monthly degarelix (240/80 mg) or goserelin (3.6 mg) for 12 weeks. • For flare protection, goserelin-treated patients also received daily bicalutamide (50 mg) during the initial 28 days.

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

CompletedPhase 3Results postedNCT00884273

Investigation of the Effect of Degarelix in Terms of Prostate Volume Reduction in Prostate Cancer Patients

Ferring Pharmaceuticalsn = 182Aug 2009 to Mar 2011

Prostate Cancer

Trial pageClinicalTrials.govUpdated 13 Nov 2013

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.

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