A 1-year, open label, randomized phase II dose finding study of degarelix for the treatment of prostate cancer in North America.

Gittelman M, Pommerville PJ, Persson BE, Jensen JK, Olesen TK

The Journal of urology17 Sept 2008Cited by 67 (Europe PMC)

PMID18801505DOI10.1016/j.juro.2008.07.033PepBankPUB-18801505

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 trialEfficacy outcome
In prostate cancer patients, 88% had testosterone of 0.5 ng/ml or less 1 month after the starting degarelix dose.
In plain wordsIn prostate cancer patients, 88% had suppressed testosterone 1 month after the starting degarelix dose.
Peptide
Degarelix
Outcome
DecreaseTestosterone suppression after starting dose
Study
n = 127
Outcome group
Sex hormones and fertility · Endocrine and hormones
Studied dose
200 mg starting dose · 1 monthAs given in this study (human).
Measurements
Patients with testosterone <=0.5 ng/ml
88%
1 month after the 200 mg starting injection
Source sentences
Summary
The starting dose induced a rapid suppression of testosterone in that 88% of the patients had testosterone levels of 0.5 ng/ml or less 1 month after the injection.
2 context sentences(design, population, supporting numbers)
Summary · context
In the present open label, randomized study in North America we evaluated the efficacy and safety of a starting dose of 200 mg degarelix followed by monthly injections of 60 or 80 mg during 1 year of prostate cancer treatment.
Summary · context
A total of 127 patients (median age 76 years, range 47 to 93) with histologically confirmed prostate cancer were enrolled in the study.
Report a problemFND-1880150501
02HumanNon-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 = 127
Outcome group
Adverse events · Endocrine and hormones
Studied dose
Dose not stated · 1 yearAs given in this study (human).
Source sentences
Summary
No evidence of testosterone surge was detected.
2 context sentences(design, population, supporting numbers)
Summary · context
In the present open label, randomized study in North America we evaluated the efficacy and safety of a starting dose of 200 mg degarelix followed by monthly injections of 60 or 80 mg during 1 year of prostate cancer treatment.
Summary · context
A total of 127 patients (median age 76 years, range 47 to 93) with histologically confirmed prostate cancer were enrolled in the study.
Report a problemFND-1880150504
03HumanNon-randomized trialEfficacy outcome
In both degarelix dose groups, PSA decreased by 96% after 1 year in prostate cancer patients.
In plain wordsIn prostate cancer patients, PSA decreased by 96% after 1 year in both degarelix dose groups.
Peptide
Degarelix
Outcome
DecreasePSA reduction
Study
n = 127
Outcome group
Tumor growth · Cancer
Studied dose
200 mg followed by 60 or 80 mg monthly · 1 yearAs given in this study (human).
Measurements
PSA decrease
96%
after 1 year, both dose groups
Source sentences
Summary
In both groups prostate specific antigen decreased by 96% after 1 year and median time to 90% reduction in prostate specific antigen was 56 days.
2 context sentences(design, population, supporting numbers)
Summary · context
In the present open label, randomized study in North America we evaluated the efficacy and safety of a starting dose of 200 mg degarelix followed by monthly injections of 60 or 80 mg during 1 year of prostate cancer treatment.
Summary · context
A total of 127 patients (median age 76 years, range 47 to 93) with histologically confirmed prostate cancer were enrolled in the study.
Report a problemFND-1880150505
04HumanNon-randomized trialEfficacy outcome
In prostate cancer patients receiving degarelix, median time to 90% PSA reduction was 56 days in both dose groups.
In plain wordsIn prostate cancer patients receiving degarelix, median time to 90% PSA reduction was 56 days in both dose groups.
Peptide
Degarelix
Outcome
Direction not reportedTime to PSA reduction
Study
n = 127
Outcome group
Tumor growth · Cancer
Studied dose
Dose not stated · 1 yearAs given in this study (human).
Measurements
Median time to 90% PSA reduction
56 days
both dose groups
Source sentences
Summary
In both groups prostate specific antigen decreased by 96% after 1 year and median time to 90% reduction in prostate specific antigen was 56 days.
2 context sentences(design, population, supporting numbers)
Summary · context
In the present open label, randomized study in North America we evaluated the efficacy and safety of a starting dose of 200 mg degarelix followed by monthly injections of 60 or 80 mg during 1 year of prostate cancer treatment.
Summary · context
A total of 127 patients (median age 76 years, range 47 to 93) with histologically confirmed prostate cancer were enrolled in the study.
Report a problemFND-1880150506
05HumanNon-randomized trialSafety outcome
In prostate cancer patients receiving degarelix, 6 patients (5%) withdrew due to adverse events.
In plain wordsIn prostate cancer patients receiving degarelix, 6 patients (5%) withdrew due to adverse events.
Peptide
Degarelix
Outcome
Direction not reportedWithdrawal due to adverse events
Study
n = 127
Outcome group
Adverse events · Whole body
Studied dose
Dose not stated · 1 yearAs given in this study (human).
Measurements
Withdrawals due to adverse events
6 patients
whole study
Withdrawals due to adverse events
5%
whole study
Source sentences
Summary
Six patients (5%) withdrew from the study due to adverse events.
2 context sentences(design, population, supporting numbers)
Summary · context
In the present open label, randomized study in North America we evaluated the efficacy and safety of a starting dose of 200 mg degarelix followed by monthly injections of 60 or 80 mg during 1 year of prostate cancer treatment.
Summary · context
A total of 127 patients (median age 76 years, range 47 to 93) with histologically confirmed prostate cancer were enrolled in the study.
Report a problemFND-1880150507
06HumanObservational studyEfficacy outcome
Among patients suppressed after 1 month, 93% receiving degarelix 60 mg maintained testosterone at 0.5 ng/ml or less through 1 year.
In plain wordsAmong prostate cancer patients suppressed after 1 month, 93% receiving degarelix 60 mg maintained suppression through 1 year.
Peptide
Degarelix
Outcome
DecreaseSustained testosterone suppression
Study
n: not reported in source
Outcome group
Sex hormones and fertility · Endocrine and hormones
Studied dose
60 mg monthly maintenance · 1 yearAs given in this study (human).
Measurements
Patients with testosterone consistently <=0.5 ng/ml, 1 month to 1 year
93%
60 mg maintenance, patients suppressed at 1 month
Source sentences
Summary
For patients who had testosterone levels of 0.5 ng/ml or less after 1 month, 93% and 98% of those receiving maintenance doses of 60 and 80 mg, respectively, had testosterone levels that were consistently 0.5 ng/ml or less at all monthly measurements from 1 month to 1 year.
2 context sentences(design, population, supporting numbers)
Summary · context
In the present open label, randomized study in North America we evaluated the efficacy and safety of a starting dose of 200 mg degarelix followed by monthly injections of 60 or 80 mg during 1 year of prostate cancer treatment.
Summary · context
A total of 127 patients (median age 76 years, range 47 to 93) with histologically confirmed prostate cancer were enrolled in the study.
Report a problemFND-1880150502
07HumanObservational studyEfficacy outcome
Among patients suppressed after 1 month, 98% receiving degarelix 80 mg maintained testosterone at 0.5 ng/ml or less through 1 year.
In plain wordsAmong prostate cancer patients suppressed after 1 month, 98% receiving degarelix 80 mg maintained suppression through 1 year.
Peptide
Degarelix
Outcome
DecreaseSustained testosterone suppression
Study
n: not reported in source
Outcome group
Sex hormones and fertility · Endocrine and hormones
Studied dose
80 mg monthly maintenance · 1 yearAs given in this study (human).
Measurements
Patients with testosterone consistently <=0.5 ng/ml, 1 month to 1 year
98%
80 mg maintenance, patients suppressed at 1 month
Source sentences
Summary
For patients who had testosterone levels of 0.5 ng/ml or less after 1 month, 93% and 98% of those receiving maintenance doses of 60 and 80 mg, respectively, had testosterone levels that were consistently 0.5 ng/ml or less at all monthly measurements from 1 month to 1 year.
2 context sentences(design, population, supporting numbers)
Summary · context
In the present open label, randomized study in North America we evaluated the efficacy and safety of a starting dose of 200 mg degarelix followed by monthly injections of 60 or 80 mg during 1 year of prostate cancer treatment.
Summary · context
A total of 127 patients (median age 76 years, range 47 to 93) with histologically confirmed prostate cancer were enrolled in the study.
Report a problemFND-1880150503

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 postedNCT00116779

A Parallel Group Comparison of the Efficacy and Safety of Degarelix at Two Different Dosing Regimens in Patients With Prostate Cancer

Ferring Pharmaceuticalsn = 127Feb 2004 to Aug 2005

Prostate Cancer

Trial page ClinicalTrials.govUpdated 19 Dec 2011

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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