Degarelix: a novel gonadotropin-releasing hormone (GnRH) receptor blocker--results from a 1-yr, multicentre, randomised, phase 2 dosage-finding study in the treatment of prostate cancer.

Van Poppel H, Tombal B, de la Rosette JJ, Persson BE, Jensen JK, Kold Olesen T

European urology8 May 2008Cited by 91 (Europe PMC)

PMID18538469DOI10.1016/j.eururo.2008.04.065PepBankPUB-18538469

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 receiving degarelix, no evidence of testosterone surge was detected.
In plain wordsIn prostate cancer patients receiving degarelix, no evidence of testosterone surge was detected.
Peptide
Degarelix
Outcome
Direction not reportedTestosterone surge
Study
n = 187
Outcome group
Adverse events · Endocrine and hormones
Studied dose
Dose not stated · subcutaneous · 1 yrAs given in this study (human).
Source sentences
Summary
No evidence of testosterone surge was detected.
2 context sentences(design, population, supporting numbers)
Summary · context
To determine the efficacy and safety of initial doses of 200 mg or 240 mg of degarelix and thereafter monthly subcutaneous maintenance doses of 80 mg, 120 mg, or 160 mg of degarelix for the treatment of prostate cancer.
Summary · context
The 1-yr study was of open-label, randomised design and involved 187 patients (range: 52-93 yr, median: 72 yr) with histologically confirmed adenocarcinoma of the prostate and a baseline PSA >2 ng/ml.
Report a problemFND-1853846904
02HumanNon-randomized trialEfficacy outcome
In prostate cancer patients, PSA decreased by 97-98% after 1 yr of degarelix.
In plain wordsIn prostate cancer patients, PSA decreased by 97-98% after 1 yr of degarelix.
Peptide
Degarelix
Outcome
DecreasePSA reduction
Study
n = 187
Outcome group
Tumor growth · Cancer
Studied dose
Dose not stated · subcutaneous · 1 yrAs given in this study (human).
Measurements
PSA decrease
97 to 98%
after 1 yr
Source sentences
Summary
PSA decreased by 97-98% after 1 yr and the median time to 90% reduction in PSA was 8 wk in all but one patient (from the 80-mg dosage treatment group at the initial 200-mg dose of degarelix).
2 context sentences(design, population, supporting numbers)
Summary · context
To determine the efficacy and safety of initial doses of 200 mg or 240 mg of degarelix and thereafter monthly subcutaneous maintenance doses of 80 mg, 120 mg, or 160 mg of degarelix for the treatment of prostate cancer.
Summary · context
The 1-yr study was of open-label, randomised design and involved 187 patients (range: 52-93 yr, median: 72 yr) with histologically confirmed adenocarcinoma of the prostate and a baseline PSA >2 ng/ml.
Report a problemFND-1853846905
03HumanNon-randomized trialEfficacy outcome
In prostate cancer patients receiving degarelix, median time to 90% PSA reduction was 8 wk except one patient receiving 200/80 mg.
In plain wordsIn prostate cancer patients receiving degarelix, median time to 90% PSA reduction was 8 wk except one patient receiving 200/80 mg.
Peptide
Degarelix
Outcome
Direction not reportedTime to PSA reduction
Study
n = 187
Outcome group
Tumor growth · Cancer
Studied dose
Dose not stated · subcutaneous · 1 yrAs given in this study (human).
Measurements
Median time to 90% PSA reduction
8 wk
all but one patient (80-mg group at initial 200-mg dose)
Source sentences
Summary
PSA decreased by 97-98% after 1 yr and the median time to 90% reduction in PSA was 8 wk in all but one patient (from the 80-mg dosage treatment group at the initial 200-mg dose of degarelix).
2 context sentences(design, population, supporting numbers)
Summary · context
To determine the efficacy and safety of initial doses of 200 mg or 240 mg of degarelix and thereafter monthly subcutaneous maintenance doses of 80 mg, 120 mg, or 160 mg of degarelix for the treatment of prostate cancer.
Summary · context
The 1-yr study was of open-label, randomised design and involved 187 patients (range: 52-93 yr, median: 72 yr) with histologically confirmed adenocarcinoma of the prostate and a baseline PSA >2 ng/ml.
Report a problemFND-1853846906
04HumanNon-randomized trialSafety outcome
In prostate cancer patients receiving degarelix, 13 patients (6%) withdrew due to adverse events, largely related to androgen deprivation.
In plain wordsIn prostate cancer patients receiving degarelix, 13 patients (6%) withdrew due to adverse events.
Peptide
Degarelix
Outcome
Direction not reportedWithdrawal due to adverse events
Study
n = 187
Outcome group
Adverse events · Whole body
Studied dose
Dose not stated · subcutaneous · 1 yrAs given in this study (human).
Measurements
Withdrawals due to adverse events
13 patients
whole study
Withdrawals due to adverse events
6%
whole study
Source sentences
Summary
Thirteen patients (6%) withdrew from the study due to adverse events, largely related to androgen deprivation.
2 context sentences(design, population, supporting numbers)
Summary · context
To determine the efficacy and safety of initial doses of 200 mg or 240 mg of degarelix and thereafter monthly subcutaneous maintenance doses of 80 mg, 120 mg, or 160 mg of degarelix for the treatment of prostate cancer.
Summary · context
The 1-yr study was of open-label, randomised design and involved 187 patients (range: 52-93 yr, median: 72 yr) with histologically confirmed adenocarcinoma of the prostate and a baseline PSA >2 ng/ml.
Report a problemFND-1853846907
05HumanNon-randomized trialEfficacy outcome
In prostate cancer patients, 88% had testosterone at or below 0.5 ng/ml on day 3 after an initial 200-mg degarelix dose.
In plain wordsIn prostate cancer patients, 88% had suppressed testosterone on day 3 after an initial 200-mg degarelix dose.
Peptide
Degarelix
Outcome
DecreaseTestosterone suppression on day 3
Study
n: not reported in source
Outcome group
Sex hormones and fertility · Endocrine and hormones
Studied dose
200 mg initial · subcutaneous · 3 daysAs given in this study (human).
Measurements
Proportion of patients with testosterone <=0.5 ng/ml
88%
day 3, 200-mg initial degarelix dose
Source sentences
Summary
On day 3, 88% and 92% of patients in the groups to whom 200-mg and 240-mg initial doses of degarelix were administered, respectively, had testosterone levels < or =0.5 ng/ml.
2 context sentences(design, population, supporting numbers)
Summary · context
To determine the efficacy and safety of initial doses of 200 mg or 240 mg of degarelix and thereafter monthly subcutaneous maintenance doses of 80 mg, 120 mg, or 160 mg of degarelix for the treatment of prostate cancer.
Summary · context
The 1-yr study was of open-label, randomised design and involved 187 patients (range: 52-93 yr, median: 72 yr) with histologically confirmed adenocarcinoma of the prostate and a baseline PSA >2 ng/ml.
Report a problemFND-1853846901
06HumanNon-randomized trialEfficacy outcome
In prostate cancer patients, 92% had testosterone at or below 0.5 ng/ml on day 3 after an initial 240-mg degarelix dose.
In plain wordsIn prostate cancer patients, 92% had suppressed testosterone on day 3 after an initial 240-mg degarelix dose.
Peptide
Degarelix
Outcome
DecreaseTestosterone suppression on day 3
Study
n: not reported in source
Outcome group
Sex hormones and fertility · Endocrine and hormones
Studied dose
240 mg initial · subcutaneous · 3 daysAs given in this study (human).
Measurements
Proportion of patients with testosterone <=0.5 ng/ml
92%
day 3, 240-mg initial degarelix dose
Source sentences
Summary
On day 3, 88% and 92% of patients in the groups to whom 200-mg and 240-mg initial doses of degarelix were administered, respectively, had testosterone levels < or =0.5 ng/ml.
2 context sentences(design, population, supporting numbers)
Summary · context
To determine the efficacy and safety of initial doses of 200 mg or 240 mg of degarelix and thereafter monthly subcutaneous maintenance doses of 80 mg, 120 mg, or 160 mg of degarelix for the treatment of prostate cancer.
Summary · context
The 1-yr study was of open-label, randomised design and involved 187 patients (range: 52-93 yr, median: 72 yr) with histologically confirmed adenocarcinoma of the prostate and a baseline PSA >2 ng/ml.
Report a problemFND-1853846902
07HumanObservational studyEfficacy outcome
Among prostate cancer patients suppressed at 1 mo, 100% receiving degarelix 160 mg monthly maintained testosterone at or below 0.5 ng/ml through study end.
In plain wordsAmong prostate cancer patients suppressed after one month, all receiving degarelix 160 mg monthly maintained testosterone suppression through study end.
Peptide
Degarelix
Outcome
DecreaseSustained testosterone suppression
Study
n: not reported in source
Outcome group
Sex hormones and fertility · Endocrine and hormones
Studied dose
160 mg monthly maintenance · subcutaneous · 1 yrAs given in this study (human).
Measurements
Patients with testosterone remaining <=0.5 ng/ml until study end
100%
160 mg monthly maintenance, patients with testosterone <=0.5 ng/ml at 1 mo
Source sentences
Summary
For patients with testosterone levels < or =0.5 ng/ml at 1 mo, the testosterone levels remained < or =0.5 ng/ml until the end of the study in 100% of the patients treated with a monthly maintenance dosage of 160 mg of degarelix.
2 context sentences(design, population, supporting numbers)
Summary · context
To determine the efficacy and safety of initial doses of 200 mg or 240 mg of degarelix and thereafter monthly subcutaneous maintenance doses of 80 mg, 120 mg, or 160 mg of degarelix for the treatment of prostate cancer.
Summary · context
The 1-yr study was of open-label, randomised design and involved 187 patients (range: 52-93 yr, median: 72 yr) with histologically confirmed adenocarcinoma of the prostate and a baseline PSA >2 ng/ml.
Report a problemFND-1853846903

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

Registered trials2

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

2 trials · 2 completed · 1 with posted results · source ClinicalTrials.gov (opens in a new tab)

CompletedPhase not statedNCT01366053

Hormone Sensitive Prostate Cancer Patients Switched to Degarelix Therapy After Failing on GnRH Agonists

CMX Researchn = 125Mar 2011 to Jul 2015

Prostate Cancer

Trial page ClinicalTrials.govUpdated 22 Dec 2016

CompletedPhase 2Results postedNCT00819156

Dose Finding Trial With a New Treatment (Degarelix) for Prostate Cancer

Ferring Pharmaceuticalsn = 189Feb 2004 to Sept 2005

Prostate Cancer

Trial page ClinicalTrials.govUpdated 30 Nov 2023

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

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