Degarelix versus goserelin (+ antiandrogen flare protection) in the relief of lower urinary tract symptoms secondary to prostate cancer: results from a phase IIIb study (NCT00831233).

Anderson J, Al-Ali G, Wirth M, Gual JB, Gomez Veiga F, Colli E, van der Meulen E, Persson BE

Urologia internationalis15 Dec 2012Cited by 42 (Europe PMC)

PMID23258223DOI10.1159/000345423PepBankPUB-23258223

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 study6

6 results from studies that gave the peptide. 6 results from people.

01HumanRandomized controlled trialEfficacy outcome
In prostate cancer patients, degarelix was non-inferior to goserelin plus bicalutamide for IPSS reduction at week 12 (p = 0.20).
In plain wordsIn prostate cancer patients, degarelix was non-inferior to goserelin plus bicalutamide for urinary symptom reduction.
Peptide
Degarelix
Outcome
No significant changeIPSS reduction in full analysis set
Study
n = 40
Comparator
Goserelin plus bicalutamide
Analysis
Primary
Outcome group
Urinary continence and bladder function · Kidney and urinary
Studied dose
240/80 mg · 3 monthsAs given in this study (human).
Source sentences
Summary
Degarelix was non-inferior to G+B in reducing IPSS at week 12 in the full analysis set (p = 0.20)
2 context sentences(design, population, supporting numbers)
Summary · context
Patients were randomised to degarelix 240/80 mg or goserelin 3.6 mg + bicalutamide flare protection (G+B); both treatments were administered for 3 months.
Summary · context
40 patients received treatment (degarelix n = 27; G+B n = 13); most had locally advanced disease and were highly symptomatic.
Report a problemFND-2325822301
02HumanRandomized controlled trialEfficacy outcome
In the per-protocol prostate cancer analysis, the IPSS reduction was significantly larger with degarelix than with goserelin plus bicalutamide (p = 0.04), which was suggestive of superior reductions.
In plain wordsIn the per-protocol analysis, urinary symptom scores fell more with degarelix than goserelin plus bicalutamide, which suggested a possible advantage.
Peptide
Degarelix
Outcome
DecreaseIPSS reduction in per-protocol analysis
Study
n: not reported in source
Comparator
Goserelin plus bicalutamide
Analysis
Primary
Outcome group
Urinary continence and bladder function · Kidney and urinary
Studied dose
240/80 mg · 3 monthsAs given in this study (human).
Source sentences
Summary
Degarelix was non-inferior to G+B in reducing IPSS at week 12 in the full analysis set (p = 0.20); the significantly larger IPSS reduction in the per-protocol analysis (p = 0.04) was suggestive of superior reductions with degarelix.
2 context sentences(design, population, supporting numbers)
Summary · context
Patients were randomised to degarelix 240/80 mg or goserelin 3.6 mg + bicalutamide flare protection (G+B); both treatments were administered for 3 months.
Summary · context
40 patients received treatment (degarelix n = 27; G+B n = 13); most had locally advanced disease and were highly symptomatic.
Report a problemFND-2325822302
03HumanRandomized controlled trialEfficacy outcome
In prostate cancer patients, quality of life improved in 85% with degarelix versus 46% with goserelin plus bicalutamide (p = 0.01).
In plain wordsIn prostate cancer patients, more patients improved their quality of life with degarelix than goserelin plus bicalutamide.
Peptide
Degarelix
Outcome
IncreaseQuality of life improvement
Study
n = 40
Comparator
Goserelin plus bicalutamide
Outcome group
Quality of life · Whole body
Studied dose
240/80 mg · 3 monthsAs given in this study (human).
Measurements
Quality of life improvement
85%
degarelix
Quality of life improvement
46%
goserelin plus bicalutamide
Source sentences
Summary
Significantly more degarelix patients had improved quality of life (IPSS question) at week 12 (85 vs. 46%; p = 0.01).
2 context sentences(design, population, supporting numbers)
Summary · context
Patients were randomised to degarelix 240/80 mg or goserelin 3.6 mg + bicalutamide flare protection (G+B); both treatments were administered for 3 months.
Summary · context
40 patients received treatment (degarelix n = 27; G+B n = 13); most had locally advanced disease and were highly symptomatic.
Report a problemFND-2325822303
04HumanRandomized controlled trialEfficacy outcome
In prostate cancer patients, prostate size fell by 42% with degarelix versus 25% with goserelin plus bicalutamide (p = 0.04).
In plain wordsIn prostate cancer patients, degarelix reduced prostate size more than goserelin plus bicalutamide in a post hoc analysis.
Peptide
Degarelix
Outcome
DecreaseProstate size reduction
Study
n = 40
Comparator
Goserelin plus bicalutamide
Outcome group
Tumor growth · Kidney and urinary
Studied dose
240/80 mg · 3 monthsAs given in this study (human).
Measurements
Prostate size reduction
42%
degarelix
Prostate size reduction
25%
goserelin plus bicalutamide
Source sentences
Summary
Mean prostate size reductions at week 12 were 42 versus 25% for patients receiving degarelix versus G+B, respectively (p = 0.04; post hoc analysis).
2 context sentences(design, population, supporting numbers)
Summary · context
Patients were randomised to degarelix 240/80 mg or goserelin 3.6 mg + bicalutamide flare protection (G+B); both treatments were administered for 3 months.
Summary · context
40 patients received treatment (degarelix n = 27; G+B n = 13); most had locally advanced disease and were highly symptomatic.
Report a problemFND-2325822304
05HumanRandomized controlled trialSafety outcome
In prostate cancer patients, injection site reactions were more frequent with degarelix than goserelin plus bicalutamide.
In plain wordsIn prostate cancer patients, injection site reactions were more frequent with degarelix than goserelin plus bicalutamide.
Peptide
Degarelix
Outcome
IncreaseInjection site reactions
Study
n = 40
Comparator
Goserelin plus bicalutamide
Outcome group
Adverse events · Skin and wound
Studied dose
240/80 mg · 3 monthsAs given in this study (human).
Source sentences
Summary
Most adverse events were mild/moderate; more degarelix patients experienced injection site reactions whereas more G+B patients had urinary tract infections/cystitis.
2 context sentences(design, population, supporting numbers)
Summary · context
Patients were randomised to degarelix 240/80 mg or goserelin 3.6 mg + bicalutamide flare protection (G+B); both treatments were administered for 3 months.
Summary · context
40 patients received treatment (degarelix n = 27; G+B n = 13); most had locally advanced disease and were highly symptomatic.
Report a problemFND-2325822305
06HumanRandomized controlled trialSafety outcome
In prostate cancer patients, urinary tract infections/cystitis were less frequent with degarelix than goserelin plus bicalutamide.
In plain wordsIn prostate cancer patients, urinary infections/cystitis were less frequent with degarelix than goserelin plus bicalutamide.
Peptide
Degarelix
Outcome
DecreaseUrinary tract infections/cystitis
Study
n = 40
Comparator
Goserelin plus bicalutamide
Outcome group
Infection and antimicrobial activity · Kidney and urinary
Studied dose
240/80 mg · 3 monthsAs given in this study (human).
Source sentences
Summary
Most adverse events were mild/moderate; more degarelix patients experienced injection site reactions whereas more G+B patients had urinary tract infections/cystitis.
2 context sentences(design, population, supporting numbers)
Summary · context
Patients were randomised to degarelix 240/80 mg or goserelin 3.6 mg + bicalutamide flare protection (G+B); both treatments were administered for 3 months.
Summary · context
40 patients received treatment (degarelix n = 27; G+B n = 13); most had locally advanced disease and were highly symptomatic.
Report a problemFND-2325822306

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

TerminatedPhase 3Results postedNCT00831233

Symptomatic Study Investigating Degarelix in Patients Suffering From Prostate Cancer

Ferring Pharmaceuticalsn = 42Apr 2009 to Jul 2010

Prostate Cancer

Trial page ClinicalTrials.govUpdated 11 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.

Version 3Current
28 Oct 2026, 02:03 UTC
Study results updated
Version 2
27 Oct 2026, 16:35 UTC
Study data updated · source update from Europe PMC
Version 1
27 Oct 2026, 16:34 UTC
First added · source update from Europe PMC

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