Long-term tolerability and efficacy of degarelix: 5-year results from a phase III extension trial with a 1-arm crossover from leuprolide to degarelix.

Crawford ED, Shore ND, Moul JW, Tombal B, Schröder FH, Miller K, Boccon-Gibod L, Malmberg A, Olesen TK, Persson BE, Klotz L

Urology22 Mar 2014Cited by 43 (Europe PMC)

PMID24661333DOI10.1016/j.urology.2014.01.013PepBankPUB-24661333

Publisher page PubMedAsk about this study

Jump to 9 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: Publisher copyright. Results still quote short attributed sentences.

Results from this study9

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

01HumanNon-randomized trialSafety outcome
In prostate cancer patients in the degarelix extension, adverse event frequency was similar between both groups.
In plain wordsIn prostate cancer patients in the degarelix extension, adverse event frequency was similar between both groups.
Peptide
Degarelix
Outcome
Direction not reportedAdverse event frequency
Study
n: not reported in source
Analysis
Primary
Outcome group
Adverse events · Whole body
Studied dose
80 or 160 mg maintenance; crossover starting dose 240 mg · up to 5 yearsAs given in this study (human).
Source sentences
Summary
Adverse event frequency was similar between both the groups.
2 context sentences(design, population, supporting numbers)
Summary · context
Patients receiving degarelix who completed the 1-year trial continued on 80 mg (n = 125) or 160 mg (n = 126) maintenance doses.
Summary · context
Patients who received leuprolide were rerandomized to degarelix 240/80 mg (n = 69) or 240/160 mg (n = 65).
Report a problemFND-2466133301
02HumanNon-randomized trialSafety outcome
In prostate cancer patients receiving degarelix, adverse events included initial injection site reactions.
In plain wordsIn prostate cancer patients receiving degarelix, adverse events included initial injection site reactions.
Peptide
Degarelix
Outcome
Not applicableInjection site reactions
Study
n: not reported in source
Analysis
Primary
Outcome group
Adverse events · Skin and wound
Studied dose
80 or 160 mg maintenance; crossover starting dose 240 mg · up to 5 yearsAs given in this study (human).
Source sentences
Summary
Adverse events included initial injection site reactions, hot flushes, and increased weight.
2 context sentences(design, population, supporting numbers)
Summary · context
Patients receiving degarelix who completed the 1-year trial continued on 80 mg (n = 125) or 160 mg (n = 126) maintenance doses.
Summary · context
Patients who received leuprolide were rerandomized to degarelix 240/80 mg (n = 69) or 240/160 mg (n = 65).
Report a problemFND-2466133302
03HumanNon-randomized trialSafety outcome
In prostate cancer patients receiving degarelix, adverse events included hot flushes.
In plain wordsIn prostate cancer patients receiving degarelix, adverse events included hot flushes.
Peptide
Degarelix
Outcome
Not applicableHot flushes
Study
n: not reported in source
Analysis
Primary
Outcome group
Adverse events · Endocrine and hormones
Studied dose
80 or 160 mg maintenance; crossover starting dose 240 mg · up to 5 yearsAs given in this study (human).
Source sentences
Summary
Adverse events included initial injection site reactions, hot flushes, and increased weight.
2 context sentences(design, population, supporting numbers)
Summary · context
Patients receiving degarelix who completed the 1-year trial continued on 80 mg (n = 125) or 160 mg (n = 126) maintenance doses.
Summary · context
Patients who received leuprolide were rerandomized to degarelix 240/80 mg (n = 69) or 240/160 mg (n = 65).
Report a problemFND-2466133303
04HumanNon-randomized trialSafety outcome
In prostate cancer patients receiving degarelix, adverse events included increased weight.
In plain wordsIn prostate cancer patients receiving degarelix, adverse events included increased weight.
Peptide
Degarelix
Outcome
IncreaseIncreased weight
Study
n: not reported in source
Analysis
Primary
Outcome group
Body weight · Metabolic and weight
Studied dose
80 or 160 mg maintenance; crossover starting dose 240 mg · up to 5 yearsAs given in this study (human).
Source sentences
Summary
Adverse events included initial injection site reactions, hot flushes, and increased weight.
2 context sentences(design, population, supporting numbers)
Summary · context
Patients receiving degarelix who completed the 1-year trial continued on 80 mg (n = 125) or 160 mg (n = 126) maintenance doses.
Summary · context
Patients who received leuprolide were rerandomized to degarelix 240/80 mg (n = 69) or 240/160 mg (n = 65).
Report a problemFND-2466133304
05HumanNon-randomized trialEfficacy outcome
In prostate cancer patients, testosterone during degarelix extension treatment was similar to values during the initial trial.
In plain wordsIn prostate cancer patients, testosterone during degarelix extension treatment was similar to values during the initial trial.
Peptide
Degarelix
Outcome
Direction not reportedTestosterone during extension compared with the 1-year trial
Study
n: not reported in source
Comparator
Values during the initial trial
Analysis
Secondary
Outcome group
Sex hormones and fertility · Endocrine and hormones
Studied dose
80 or 160 mg maintenance; crossover starting dose 240 mg · up to 5 yearsAs given in this study (human).
Source sentences
Summary
Testosterone and prostate-specific antigen values during the extension study were similar to those seen during the 1-year trial in patients who continued on degarelix or crossed over from leuprolide.
2 context sentences(design, population, supporting numbers)
Summary · context
Patients receiving degarelix who completed the 1-year trial continued on 80 mg (n = 125) or 160 mg (n = 126) maintenance doses.
Summary · context
Patients who received leuprolide were rerandomized to degarelix 240/80 mg (n = 69) or 240/160 mg (n = 65).
Report a problemFND-2466133305
06HumanNon-randomized trialEfficacy outcome
In prostate cancer patients, PSA during degarelix extension treatment was similar to values during the initial trial.
In plain wordsIn prostate cancer patients, PSA during degarelix extension treatment was similar to values during the initial trial.
Peptide
Degarelix
Outcome
Direction not reportedPSA during extension compared with the 1-year trial
Study
n: not reported in source
Comparator
Values during the initial trial
Analysis
Secondary
Outcome group
Tumor growth · Cancer
Studied dose
80 or 160 mg maintenance; crossover starting dose 240 mg · up to 5 yearsAs given in this study (human).
Source sentences
Summary
Testosterone and prostate-specific antigen values during the extension study were similar to those seen during the 1-year trial in patients who continued on degarelix or crossed over from leuprolide.
2 context sentences(design, population, supporting numbers)
Summary · context
Patients receiving degarelix who completed the 1-year trial continued on 80 mg (n = 125) or 160 mg (n = 126) maintenance doses.
Summary · context
Patients who received leuprolide were rerandomized to degarelix 240/80 mg (n = 69) or 240/160 mg (n = 65).
Report a problemFND-2466133306
07HumanNon-randomized trialEfficacy outcome
In prostate cancer patients crossing to degarelix, the PSA progression-free survival hazard rate decreased from 0.20 to 0.09 (P = .002).
In plain wordsIn prostate cancer patients, the PSA progression hazard rate decreased after switching from leuprolide to degarelix.
Peptide
Degarelix
Outcome
DecreasePSA progression-free survival hazard rate after crossover
Study
n: not reported in source
Comparator
Prior leuprolide treatment
Analysis
Secondary
Outcome group
Tumor growth · Cancer
Studied dose
80 or 160 mg maintenance; crossover starting dose 240 mg · up to 5 yearsAs given in this study (human).
Measurements
Hazard rate
0.2 rate
before crossover
Hazard rate
0.09 rate
after crossover
Source sentences
Summary
The prostate-specific antigen progression-free survival hazard rate was decreased significantly after the crossover in the leuprolide to degarelix group (from 0.20 to 0.09; P = .002)
2 context sentences(design, population, supporting numbers)
Summary · context
Patients receiving degarelix who completed the 1-year trial continued on 80 mg (n = 125) or 160 mg (n = 126) maintenance doses.
Summary · context
Patients who received leuprolide were rerandomized to degarelix 240/80 mg (n = 69) or 240/160 mg (n = 65).
Report a problemFND-2466133307
08HumanNon-randomized trialEfficacy outcome
In prostate cancer patients continuing degarelix, the PSA progression-free survival hazard rate did not change significantly.
In plain wordsIn prostate cancer patients continuing degarelix, the PSA progression hazard rate did not change significantly.
Peptide
Degarelix
Outcome
No significant changePSA progression-free survival hazard rate with continued degarelix
Study
n: not reported in source
Analysis
Secondary
Outcome group
Tumor growth · Cancer
Studied dose
80 or 160 mg maintenance; crossover starting dose 240 mg · up to 5 yearsAs given in this study (human).
Source sentences
Summary
The prostate-specific antigen progression-free survival hazard rate was decreased significantly after the crossover in the leuprolide to degarelix group (from 0.20 to 0.09; P = .002), whereas in patients who continued on degarelix, the rate did not change significantly.
2 context sentences(design, population, supporting numbers)
Summary · context
Patients receiving degarelix who completed the 1-year trial continued on 80 mg (n = 125) or 160 mg (n = 126) maintenance doses.
Summary · context
Patients who received leuprolide were rerandomized to degarelix 240/80 mg (n = 69) or 240/160 mg (n = 65).
Report a problemFND-2466133308
09HumanNon-randomized trialEfficacy outcome
In patients with baseline PSA >20 ng/mL, switching to degarelix reduced the hazard rate from 0.38 to 0.19 (P = .019).
In plain wordsIn patients with high baseline PSA, the PSA progression hazard rate decreased after switching from leuprolide to degarelix.
Peptide
Degarelix
Outcome
DecreasePSA progression-free survival hazard rate in high baseline PSA subgroup
Study
n: not reported in source
Comparator
Prior leuprolide treatment
Analysis
Secondary
Outcome group
Tumor growth · Cancer
Studied dose
80 or 160 mg maintenance; crossover starting dose 240 mg · up to 5 yearsAs given in this study (human).
Measurements
Hazard rate
0.38 rate
before crossover
Hazard rate
0.19 rate
after crossover
Source sentences
Summary
In patients with baseline prostate-specific antigen >20 ng/mL, the same hazard rate change pattern was observed on crossover (from 0.38 to 0.19; P = .019).
2 context sentences(design, population, supporting numbers)
Summary · context
Patients receiving degarelix who completed the 1-year trial continued on 80 mg (n = 125) or 160 mg (n = 126) maintenance doses.
Summary · context
Patients who received leuprolide were rerandomized to degarelix 240/80 mg (n = 69) or 240/160 mg (n = 65).
Report a problemFND-2466133309

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 ongoing · source ClinicalTrials.gov (opens in a new tab)

Active, not recruitingPhase 1NCT05917860

Neoadjuvant ADT With TULSA in the Treatment of Intermediate Risk Prostate Cancer

Turku University Hospitaln = 1518 Jul 2023 to est. 31 Jan 2030

Localized Prostate Carcinoma · Castration-Naive Prostate Cancer · Intermediate Risk Prostate Cancer · Prostate Cancer

Trial page ClinicalTrials.govUpdated 13 Oct 2026

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, 16:37 UTC
Study data updated · source update from Europe PMC
Version 1
27 Oct 2026, 16:34 UTC
First added · source update from Europe PMC