A phase III extension trial with a 1-arm crossover from leuprolide to degarelix: comparison of gonadotropin-releasing hormone agonist and antagonist effect on prostate cancer.

Crawford ED, Tombal B, Miller K, Boccon-Gibod L, Schröder F, Shore N, Moul JW, Jensen JK, Olesen TK, Persson BE

The Journal of urology23 Jul 2011Cited by 102 (Europe PMC)

PMID21788033DOI10.1016/j.juro.2011.04.083PepBankPUB-21788033

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 study7

7 results from studies that gave the peptide. 7 results from people.

01HumanNon-randomized trialSafety outcome
In prostate cancer patients, adverse event frequency was similar between continued and switched degarelix groups.
In plain wordsIn prostate cancer patients, adverse event frequency was similar between continued and switched degarelix groups.
Peptide
Degarelix
Outcome
No significant changeAdverse event frequency between groups
Study
n: not reported in source
Comparator
continued versus switched degarelix
Analysis
Primary
Outcome group
Adverse events · Whole body
Studied dose
240/80 mg · median 27.5-month followupAs given in this study (human).
Source sentences
Summary
Adverse event frequency was similar between the groups and decreased with time.
2 context sentences(design, population, supporting numbers)
Summary · context
Patients who completed a 1-year pivotal phase III trial continued on the same monthly degarelix maintenance dose (160 or 80 mg in 125 each), or were re-randomized from leuprolide 7.5 mg to degarelix 240/80 mg (69) or 240/160 mg (65).
Summary · context
Data are shown on the approved degarelix 240/80 mg dose.
Report a problemFND-2178803306
02HumanNon-randomized trialSafety outcome
In prostate cancer patients receiving degarelix, adverse event frequency decreased with time.
In plain wordsIn prostate cancer patients receiving degarelix, adverse event frequency decreased with time.
Peptide
Degarelix
Outcome
DecreaseAdverse event frequency over time
Study
n: not reported in source
Analysis
Primary
Outcome group
Adverse events · Whole body
Studied dose
240/80 mg · median 27.5-month followupAs given in this study (human).
Source sentences
Summary
Adverse event frequency was similar between the groups and decreased with time.
2 context sentences(design, population, supporting numbers)
Summary · context
Patients who completed a 1-year pivotal phase III trial continued on the same monthly degarelix maintenance dose (160 or 80 mg in 125 each), or were re-randomized from leuprolide 7.5 mg to degarelix 240/80 mg (69) or 240/160 mg (65).
Summary · context
Data are shown on the approved degarelix 240/80 mg dose.
Report a problemFND-2178803307
03HumanNon-randomized trialEfficacy outcome
In prostate cancer patients, testosterone suppression during continued or switched degarelix treatment was similar to the prior trial.
In plain wordsIn prostate cancer patients, degarelix maintained testosterone suppression similar to the prior trial.
Peptide
Degarelix
Outcome
No significant changeTestosterone suppression
Study
n: not reported in source
Comparator
1-year trial
Analysis
Secondary
Outcome group
Sex hormones and fertility · Endocrine and hormones
Studied dose
240/80 mg · median 27.5-month followupAs given in this study (human).
Source sentences
Summary
During followup testosterone and prostate specific antigen suppression were similar to those in the 1-year trial in patients who continued on degarelix or switched from leuprolide.
2 context sentences(design, population, supporting numbers)
Summary · context
Patients who completed a 1-year pivotal phase III trial continued on the same monthly degarelix maintenance dose (160 or 80 mg in 125 each), or were re-randomized from leuprolide 7.5 mg to degarelix 240/80 mg (69) or 240/160 mg (65).
Summary · context
Data are shown on the approved degarelix 240/80 mg dose.
Report a problemFND-2178803301
04HumanNon-randomized trialEfficacy outcome
In prostate cancer patients, PSA suppression during continued or switched degarelix treatment was similar to the prior trial.
In plain wordsIn prostate cancer patients, degarelix maintained PSA suppression similar to the prior trial.
Peptide
Degarelix
Outcome
No significant changePSA suppression
Study
n: not reported in source
Comparator
1-year trial
Analysis
Secondary
Outcome group
Tumor growth · Cancer
Studied dose
240/80 mg · median 27.5-month followupAs given in this study (human).
Source sentences
Summary
During followup testosterone and prostate specific antigen suppression were similar to those in the 1-year trial in patients who continued on degarelix or switched from leuprolide.
2 context sentences(design, population, supporting numbers)
Summary · context
Patients who completed a 1-year pivotal phase III trial continued on the same monthly degarelix maintenance dose (160 or 80 mg in 125 each), or were re-randomized from leuprolide 7.5 mg to degarelix 240/80 mg (69) or 240/160 mg (65).
Summary · context
Data are shown on the approved degarelix 240/80 mg dose.
Report a problemFND-2178803302
05HumanNon-randomized trialEfficacy outcome
In prostate cancer patients, the PSA progression-free survival hazard rate decreased significantly after switching from leuprolide to degarelix.
In plain wordsIn prostate cancer patients, the PSA progression-free survival hazard rate decreased after switching from leuprolide to degarelix.
Peptide
Degarelix
Outcome
DecreasePSA progression-free survival hazard rate after switching
Study
n: not reported in source
Analysis
Secondary
Outcome group
Tumor growth · Cancer
Studied dose
240/80 mg · median 27.5-month followupAs given in this study (human).
Source sentences
Summary
The prostate specific antigen progression-free survival hazard rate was decreased significantly after the switch in the leuprolide/degarelix group while the rate in those who continued on degarelix was consistent with the rate in treatment year 1.
2 context sentences(design, population, supporting numbers)
Summary · context
Patients who completed a 1-year pivotal phase III trial continued on the same monthly degarelix maintenance dose (160 or 80 mg in 125 each), or were re-randomized from leuprolide 7.5 mg to degarelix 240/80 mg (69) or 240/160 mg (65).
Summary · context
Data are shown on the approved degarelix 240/80 mg dose.
Report a problemFND-2178803303
06HumanNon-randomized trialEfficacy outcome
In prostate cancer patients continuing degarelix, the PSA progression-free survival hazard rate remained consistent with treatment year 1.
In plain wordsIn prostate cancer patients continuing degarelix, the PSA progression-free survival hazard rate remained consistent with the first treatment year.
Peptide
Degarelix
Outcome
No significant changePSA progression-free survival hazard rate with continued treatment
Study
n: not reported in source
Comparator
treatment year 1
Analysis
Secondary
Outcome group
Tumor growth · Cancer
Studied dose
240/80 mg · median 27.5-month followupAs given in this study (human).
Source sentences
Summary
The prostate specific antigen progression-free survival hazard rate was decreased significantly after the switch in the leuprolide/degarelix group while the rate in those who continued on degarelix was consistent with the rate in treatment year 1.
2 context sentences(design, population, supporting numbers)
Summary · context
Patients who completed a 1-year pivotal phase III trial continued on the same monthly degarelix maintenance dose (160 or 80 mg in 125 each), or were re-randomized from leuprolide 7.5 mg to degarelix 240/80 mg (69) or 240/160 mg (65).
Summary · context
Data are shown on the approved degarelix 240/80 mg dose.
Report a problemFND-2178803304
07HumanNon-randomized trialEfficacy outcome
In prostate cancer patients with baseline PSA greater than 20 ng/ml, the same hazard rate pattern occurred: the PSA progression-free survival hazard rate decreased after the switch from leuprolide to degarelix and was consistent with treatment year 1 in those who continued on degarelix.
In plain wordsIn patients with high baseline PSA, the PSA progression hazard rate fell after switching to degarelix and was consistent with year 1 in those continuing.
Peptide
Degarelix
Outcome
MixedPSA progression-free survival hazard rate in high baseline PSA subgroup
Study
n: not reported in source
Analysis
Secondary
Outcome group
Tumor growth · Cancer
Studied dose
240/80 mg · median 27.5-month followupAs given in this study (human).
Source sentences
Summary
The same hazard rate change pattern occurred in the group with baseline prostate specific antigen greater than 20 ng/ml.
3 context sentences(design, population, supporting numbers)
Summary · context
The prostate specific antigen progression-free survival hazard rate was decreased significantly after the switch in the leuprolide/degarelix group while the rate in those who continued on degarelix was consistent with the rate in treatment year 1.
Summary · context
Patients who completed a 1-year pivotal phase III trial continued on the same monthly degarelix maintenance dose (160 or 80 mg in 125 each), or were re-randomized from leuprolide 7.5 mg to degarelix 240/80 mg (69) or 240/160 mg (65).
Summary · context
Data are shown on the approved degarelix 240/80 mg dose.
Report a problemFND-2178803305

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

WithdrawnPhase 2NCT01630967

Efficacy Study of Switching to a Lutenizing Hormone-releasing Hormone (LHRH) Antagonist From a LHRH Agonist to Treat Progressive Castrate Resistant Prostate Cancer (CRPC)

British Columbia Cancer Agencyn = 0est. Aug 2012 to est. Dec 2013

Prostate Neoplasm

Trial page ClinicalTrials.govUpdated 1 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