A Phase II, Randomized, Multicenter Study Comparing 10 Months versus 4 Months of Degarelix Therapy in Prolonging the Off Treatment Interval in Men with Localized Prostate Cancer Receiving Intermittent Androgen Deprivation Therapy for Biochemical Recurrence following Radical Local Therapy.

Klotz L, Loblaw A, Siemens R, Ouellette P, Kapoor A, Kebabdjian M, Zhang L, Saad F

The Journal of urology11 Mar 2018Cited by 7 (Europe PMC)

PMID29534997DOI10.1016/j.juro.2018.03.010PepBankPUB-29534997

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 study6

6 results from studies that gave the peptide. 6 results from people.

01HumanRandomized controlled trialEfficacy outcome
In men with recurrent prostate cancer, time off treatment did not differ after 10 versus 4 months of degarelix.
In plain wordsIn men with recurrent prostate cancer, time off treatment did not differ after 10 versus 4 months of degarelix.
Peptide
Degarelix
Outcome
No significant changeTime off treatment
Study
n = 90
Comparator
4 months of degarelix
Outcome group
Treatment-free interval · Cancer
Studied dose
240 mg initially, then 80 mg per month · 4 months versus 10 months of monthly degarelixAs given in this study (human).
Measurements
Hazard ratio
1.51 ratio
95% CI 0.60-3.84; p=0.38
Source sentences
Summary
There was no difference between the 2 treatment groups in time off treatment (HR 1.51, 95% CI 0.60-3.84, p = 0.38).
4 context sentences(design, population, supporting numbers)
Summary · context
This was a prospective, randomized, open label study.
Summary · context
Men with biochemical recurrence after local therapy for prostate cancer and a negative bone scan were randomized to 4 and 10 months of monthly degarelix.
Summary · context
The first dose was 240 mg and subsequent doses were 80 mg per month.
Summary · context
A total of 90 patients were randomized, including 43 to 4 months and 47 to 10 months of treatment.
Report a problemFND-2953499701
02HumanRandomized controlled trialEfficacy outcome
In men with recurrent prostate cancer, testosterone recovery time did not differ significantly after 10 versus 4 months of degarelix.
In plain wordsIn men with recurrent prostate cancer, testosterone recovery time did not differ significantly after 10 versus 4 months of degarelix.
Peptide
Degarelix
Outcome
No significant changeTime to testosterone recovery
Study
n = 90
Comparator
4 months of degarelix
Outcome group
Sex hormones and fertility · Endocrine and hormones
Studied dose
240 mg initially, then 80 mg per month · 4 months versus 10 months of monthly degarelixAs given in this study (human).
Measurements
Median recovery time
8.05 months
10-month arm; 95% CI 4.34-39.89; threshold 8.0 nmol/l
Median recovery time
6.24 months
4-month arm; 95% CI 5.45-15.90
P value
0.8392 NA
log rank test
Source sentences
Summary
Actuarial median time to testosterone recovery to 8.0 nmol/l or greater was 8.05 months (95% CI 4.34-39.89) in the 10-month treatment arm and 6.24 months (95% CI 5.45-15.90) in the 4-month treatment arm.
5 context sentences(design, population, supporting numbers)
Summary · context
The log rank test showed no statistical significance between the 2 treatment groups in time to testosterone recovery (p = 0.8392).
Summary · context
This was a prospective, randomized, open label study.
Summary · context
Men with biochemical recurrence after local therapy for prostate cancer and a negative bone scan were randomized to 4 and 10 months of monthly degarelix.
Summary · context
The first dose was 240 mg and subsequent doses were 80 mg per month.
Summary · context
A total of 90 patients were randomized, including 43 to 4 months and 47 to 10 months of treatment.
Report a problemFND-2953499702
03HumanRandomized controlled trialEfficacy outcome
In men with recurrent prostate cancer, testosterone recovery rates did not differ after 10 versus 4 months of degarelix.
In plain wordsIn men with recurrent prostate cancer, testosterone recovery rates did not differ after 10 versus 4 months of degarelix.
Peptide
Degarelix
Outcome
No significant changeTestosterone recovery rate
Study
n = 90
Comparator
4 months of degarelix
Outcome group
Sex hormones and fertility · Endocrine and hormones
Studied dose
240 mg initially, then 80 mg per month · 4 months versus 10 months of monthly degarelixAs given in this study (human).
Source sentences
Summary
There was no difference in the testosterone recovery rate between the 2 arms.
4 context sentences(design, population, supporting numbers)
Summary · context
This was a prospective, randomized, open label study.
Summary · context
Men with biochemical recurrence after local therapy for prostate cancer and a negative bone scan were randomized to 4 and 10 months of monthly degarelix.
Summary · context
The first dose was 240 mg and subsequent doses were 80 mg per month.
Summary · context
A total of 90 patients were randomized, including 43 to 4 months and 47 to 10 months of treatment.
Report a problemFND-2953499703
04HumanRandomized controlled trialSafety outcome
In men with recurrent prostate cancer, quality of life suffered less after 4 than 10 months of degarelix.
In plain wordsIn men with recurrent prostate cancer, quality of life suffered less after 4 than 10 months of degarelix.
Peptide
Degarelix
Outcome
DecreaseQuality of life at treatment end
Study
n = 90
Comparator
10 months of degarelix
Outcome group
Quality of life · Whole body
Studied dose
240 mg initially, then 80 mg per month · 4 months versus 10 months of monthly degarelixAs given in this study (human).
Source sentences
Summary
There was a lesser adverse effect on quality of life at the end of treatment in the 4-month than in the 10-month arm.
4 context sentences(design, population, supporting numbers)
Summary · context
This was a prospective, randomized, open label study.
Summary · context
Men with biochemical recurrence after local therapy for prostate cancer and a negative bone scan were randomized to 4 and 10 months of monthly degarelix.
Summary · context
The first dose was 240 mg and subsequent doses were 80 mg per month.
Summary · context
A total of 90 patients were randomized, including 43 to 4 months and 47 to 10 months of treatment.
Report a problemFND-2953499706
05HumanObservational studyEfficacy outcome
Among men receiving intermittent degarelix for recurrent prostate cancer, those younger than 65 years had a shorter off-treatment interval.
In plain wordsAmong men receiving degarelix for recurrent prostate cancer, age below 65 was linked to a shorter off-treatment interval.
Peptide
Degarelix
Outcome
DecreaseOff-treatment interval by age
Study
n: not reported in source
Comparator
Men aged 65 years or older receiving degarelix
Outcome group
Treatment-free interval · Cancer
Studied dose
240 mg initially, then 80 mg per monthAs given in this study (human).
Source sentences
Summary
Men younger than 65 years had a considerably shorter interval off treatment and time to testosterone recovery.
4 context sentences(design, population, supporting numbers)
Summary · context
This was a prospective, randomized, open label study.
Summary · context
Men with biochemical recurrence after local therapy for prostate cancer and a negative bone scan were randomized to 4 and 10 months of monthly degarelix.
Summary · context
The first dose was 240 mg and subsequent doses were 80 mg per month.
Summary · context
A total of 90 patients were randomized, including 43 to 4 months and 47 to 10 months of treatment.
Report a problemFND-2953499704
06HumanObservational studyEfficacy outcome
Among men receiving intermittent degarelix for recurrent prostate cancer, those younger than 65 years had a shorter time to testosterone recovery.
In plain wordsAmong men receiving degarelix for recurrent prostate cancer, age below 65 was linked to faster testosterone recovery.
Peptide
Degarelix
Outcome
DecreaseTestosterone recovery time by age
Study
n: not reported in source
Comparator
Men aged 65 years or older receiving degarelix
Outcome group
Sex hormones and fertility · Endocrine and hormones
Studied dose
240 mg initially, then 80 mg per monthAs given in this study (human).
Source sentences
Summary
Men younger than 65 years had a considerably shorter interval off treatment and time to testosterone recovery.
4 context sentences(design, population, supporting numbers)
Summary · context
This was a prospective, randomized, open label study.
Summary · context
Men with biochemical recurrence after local therapy for prostate cancer and a negative bone scan were randomized to 4 and 10 months of monthly degarelix.
Summary · context
The first dose was 240 mg and subsequent doses were 80 mg per month.
Summary · context
A total of 90 patients were randomized, including 43 to 4 months and 47 to 10 months of treatment.
Report a problemFND-2953499705

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

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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A Phase II, Randomized, Multicenter Study Comparing 10 Months versus 4 Months of Degarelix Therapy in Prolonging the Off Treatment Interval in Men with Localized Prostate Cancer Receiving Intermittent Androgen Deprivation Therapy for Biochemical Recurrence following Radical Local Therapy.

Summary

Results from this study6

Version history

Subjects

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MeSH terms

Keywords