Efficacy of degarelix in prostate cancer patients following failure on luteinizing hormone-releasing hormone agonist treatment: results from an open-label, multicentre, uncontrolled, phase II trial (CS27).

Miller K, Simson G, Goble S, Persson BE

Therapeutic advances in urology1 Jun 2015Cited by 9 (Europe PMC)

PMID26161141PMCIDPMC4485413DOI10.1177/1756287215574479PepBankPUB-26161141

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 study5

5 results from studies that gave the peptide. 5 results from people.

01HumanNon-randomized trialEfficacy outcome
In prostate cancer patients after LHRH agonist failure, decreasing or stable PSA (≤+10% from baseline) occurred in 16.7% of Cohort 1 at Month 3.
In plain wordsIn prostate cancer patients after LHRH agonist failure, degarelix PSA response was 16.7% in Cohort 1.
Peptide
Degarelix
Outcome
Not applicablePSA response at Month 3, Cohort 1
Study
n = 25
Analysis
Primary
Outcome group
Tumor growth · Cancer
Studied dose
240 mg followed by 11 monthly doses of 80 mg · 1 yearAs given in this study (human).
Measurements
PSA response rate
16.7%
Cohort 1, Month 3
95% CI
4.74 to 37.38%
Cohort 1
Source sentences
Summary
At Month 3, the response rate (intention-to-treat, last observation carried forward analysis) was 16.7% [95% confidence interval (CI): 4.74-37.38] in Cohort 1 and 33.3% (95% CI: 9.92-65.11) in Cohort 2.
3 context sentences(design, population, supporting numbers)
Summary · context
This 1-year exploratory, multicentre, open-label phase II trial was performed in 2 patient cohorts (Cohort 1, n = 25; Cohort 2, n = 12) in Germany.
Summary · context
Patients with castrate-resistant PCa after primary hormonal treatment received degarelix 240 mg, followed by 11 monthly maintenance doses of 80 mg.
Summary · context
The primary endpoint was the proportion of patients with decreasing/stable prostate-specific antigen (PSA) (relative change ⩽+10% of baseline PSA) after 3 months.
Report a problemFND-2616114101
02HumanNon-randomized trialEfficacy outcome
In prostate cancer patients after LHRH agonist failure, decreasing or stable PSA (≤+10% from baseline) occurred in 33.3% of Cohort 2 at Month 3.
In plain wordsIn prostate cancer patients after LHRH agonist failure, degarelix PSA response was 33.3% in Cohort 2.
Peptide
Degarelix
Outcome
Not applicablePSA response at Month 3, Cohort 2
Study
n = 12
Analysis
Primary
Outcome group
Tumor growth · Cancer
Studied dose
240 mg followed by 11 monthly doses of 80 mg · 1 yearAs given in this study (human).
Measurements
PSA response rate
33.3%
Cohort 2, Month 3
95% CI
9.92 to 65.11%
Cohort 2
Source sentences
Summary
At Month 3, the response rate (intention-to-treat, last observation carried forward analysis) was 16.7% [95% confidence interval (CI): 4.74-37.38] in Cohort 1 and 33.3% (95% CI: 9.92-65.11) in Cohort 2.
3 context sentences(design, population, supporting numbers)
Summary · context
This 1-year exploratory, multicentre, open-label phase II trial was performed in 2 patient cohorts (Cohort 1, n = 25; Cohort 2, n = 12) in Germany.
Summary · context
Patients with castrate-resistant PCa after primary hormonal treatment received degarelix 240 mg, followed by 11 monthly maintenance doses of 80 mg.
Summary · context
The primary endpoint was the proportion of patients with decreasing/stable prostate-specific antigen (PSA) (relative change ⩽+10% of baseline PSA) after 3 months.
Report a problemFND-2616114102
03HumanNon-randomized trialSafety outcome
In prostate cancer patients receiving second-line degarelix, local injection-site reactions were the most frequently reported adverse events.
In plain wordsIn prostate cancer patients receiving second-line degarelix, local injection-site reactions were the most frequent adverse events.
Peptide
Degarelix
Outcome
Not applicableLocal injection-site reactions
Study
n = 37
Outcome group
Adverse events · Skin and wound
Studied dose
240 mg followed by 11 monthly doses of 80 mg · 1 yearAs given in this study (human).
Source sentences
Summary
Degarelix was well tolerated; the most frequently reported adverse events were local injection-site reactions.
3 context sentences(design, population, supporting numbers)
Summary · context
This 1-year exploratory, multicentre, open-label phase II trial was performed in 2 patient cohorts (Cohort 1, n = 25; Cohort 2, n = 12) in Germany.
Summary · context
Patients with castrate-resistant PCa after primary hormonal treatment received degarelix 240 mg, followed by 11 monthly maintenance doses of 80 mg.
Summary · context
The primary endpoint was the proportion of patients with decreasing/stable prostate-specific antigen (PSA) (relative change ⩽+10% of baseline PSA) after 3 months.
Report a problemFND-2616114105
04HumanNon-randomized trialEfficacy outcome
In prostate cancer patients receiving degarelix after LHRH agonist failure, probability of completing 12 months without PSA progression was 8.8% in Cohort 1.
In plain wordsIn prostate cancer patients receiving degarelix, probability of completing 12 months without PSA progression was 8.8% in Cohort 1.
Peptide
Degarelix
Outcome
Not applicableCompletion without PSA progression, Cohort 1
Study
n = 25
Outcome group
Tumor growth · Cancer
Studied dose
240 mg followed by 11 monthly doses of 80 mg · 1 yearAs given in this study (human).
Measurements
Probability of completing 12 months without PSA progression
8.8%
Cohort 1
95% CI
1.51 to 24.3%
Cohort 1
Source sentences
Summary
The probability of completing 12 months without PSA progression was 8.8% (95% CI: 1.51-24.3) in Cohort 1 and 8.3% (95% CI: 0.5-31.1) in Cohort 2.
3 context sentences(design, population, supporting numbers)
Summary · context
This 1-year exploratory, multicentre, open-label phase II trial was performed in 2 patient cohorts (Cohort 1, n = 25; Cohort 2, n = 12) in Germany.
Summary · context
Patients with castrate-resistant PCa after primary hormonal treatment received degarelix 240 mg, followed by 11 monthly maintenance doses of 80 mg.
Summary · context
The primary endpoint was the proportion of patients with decreasing/stable prostate-specific antigen (PSA) (relative change ⩽+10% of baseline PSA) after 3 months.
Report a problemFND-2616114103
05HumanNon-randomized trialEfficacy outcome
In prostate cancer patients receiving degarelix after LHRH agonist failure, probability of completing 12 months without PSA progression was 8.3% in Cohort 2.
In plain wordsIn prostate cancer patients receiving degarelix, probability of completing 12 months without PSA progression was 8.3% in Cohort 2.
Peptide
Degarelix
Outcome
Not applicableCompletion without PSA progression, Cohort 2
Study
n = 12
Outcome group
Tumor growth · Cancer
Studied dose
240 mg followed by 11 monthly doses of 80 mg · 1 yearAs given in this study (human).
Measurements
Probability of completing 12 months without PSA progression
8.3%
Cohort 2
95% CI
0.5 to 31.1%
Cohort 2
Source sentences
Summary
The probability of completing 12 months without PSA progression was 8.8% (95% CI: 1.51-24.3) in Cohort 1 and 8.3% (95% CI: 0.5-31.1) in Cohort 2.
3 context sentences(design, population, supporting numbers)
Summary · context
This 1-year exploratory, multicentre, open-label phase II trial was performed in 2 patient cohorts (Cohort 1, n = 25; Cohort 2, n = 12) in Germany.
Summary · context
Patients with castrate-resistant PCa after primary hormonal treatment received degarelix 240 mg, followed by 11 monthly maintenance doses of 80 mg.
Summary · context
The primary endpoint was the proportion of patients with decreasing/stable prostate-specific antigen (PSA) (relative change ⩽+10% of baseline PSA) after 3 months.
Report a problemFND-2616114104

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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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