Long-term efficacy and tolerability of once-yearly histrelin acetate subcutaneous implant in patients with advanced prostate cancer.

Shore N, Cookson MS, Gittelman MC

BJU international18 Aug 2011Cited by 17 (Europe PMC)

PMID21851539DOI10.1111/j.1464-410x.2011.10370.xPepBankPUB-21851539

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 study11

11 results from studies that gave the peptide. 11 results from people.

01HumanNon-randomized trialEfficacy outcome
In men with advanced prostate cancer, histrelin consistently suppressed testosterone below 50 ng/dL in all patients.
In plain wordsIn men with advanced prostate cancer, histrelin kept testosterone below 50 ng/dL in all patients.
Peptide
Histrelin
Outcome
DecreaseTestosterone suppression
Study
n = 104
Analysis
Primary
Outcome group
Sex hormones and fertility · Endocrine and hormones
Studied dose
Dose not stated · subcutaneousAs given in this study (human).
Measurements
Serum testosterone in all patients
< 50 ng/dL
suppressed below this level in all patients
Source sentences
Summary
Serum testosterone was consistently suppressed below 50 ng/dL in all patients and mean testosterone levels were 13.1, 14.8 and 10.8 ng/dL after 104 weeks (year 2), 156 weeks (year 3) and 208 weeks (year 4) of treatment, respectively.
3 context sentences(design, population, supporting numbers)
Summary · context
To evaluate the efficacy and tolerability of a once-yearly histrelin implant during an open-label extension of a pivotal study.
Summary · context
Men with advanced prostate cancer and a clinical response to 52 weeks of treatment with the histrelin implant.
Summary · context
Implants were placed annually.
Report a problemFND-2185153902
02HumanNon-randomized trialEfficacy outcome
Most men receiving histrelin showed no clinical worsening, continued normal daily activities, and required no analgesic medication during the extension.
In plain wordsMost men receiving histrelin had no clinical worsening, continued daily activities, and required no pain medication.
Peptide
Histrelin
Outcome
Not applicableDisease status and daily function
Study
n = 104
Analysis
Secondary
Outcome group
Tumor growth · Cancer
Studied dose
Dose not stated · subcutaneousAs given in this study (human).
Source sentences
Summary
Most patients showed no clinical worsening of their disease, were able to continue normal daily activities, and did not require analgesic medication during the extension period.
3 context sentences(design, population, supporting numbers)
Summary · context
To evaluate the efficacy and tolerability of a once-yearly histrelin implant during an open-label extension of a pivotal study.
Summary · context
Men with advanced prostate cancer and a clinical response to 52 weeks of treatment with the histrelin implant.
Summary · context
Implants were placed annually.
Report a problemFND-2185153906
03HumanNon-randomized trialSafety outcome
During histrelin treatment for advanced prostate cancer, 100 patients (96.2%) reported adverse events.
In plain wordsDuring histrelin treatment for advanced prostate cancer, 96.2% of patients reported adverse events.
Peptide
Histrelin
Outcome
Not applicableAdverse events
Study
n = 104
Analysis
Secondary
Outcome group
Adverse events · Whole body
Studied dose
Dose not stated · subcutaneousAs given in this study (human).
Measurements
Patients with adverse events
100 patients
104 enrolled
Patients with adverse events
96.2%
104 enrolled
Source sentences
Summary
Adverse events were reported in 100 (96.2%) patients.
3 context sentences(design, population, supporting numbers)
Summary · context
To evaluate the efficacy and tolerability of a once-yearly histrelin implant during an open-label extension of a pivotal study.
Summary · context
Men with advanced prostate cancer and a clinical response to 52 weeks of treatment with the histrelin implant.
Summary · context
Implants were placed annually.
Report a problemFND-2185153909
04HumanNon-randomized trialSafety outcome
Eight deaths occurred during histrelin treatment for advanced prostate cancer and were judged unrelated to the study drug.
In plain wordsEight men died during histrelin treatment for advanced prostate cancer, with deaths judged unrelated to the drug.
Peptide
Histrelin
Outcome
Not applicableDeaths
Study
n = 104
Analysis
Secondary
Outcome group
Mortality · Whole body
Studied dose
Dose not stated · subcutaneousAs given in this study (human).
Measurements
Deaths
8 deaths
judged unrelated to study drug
Source sentences
Summary
The eight deaths and 28 (26.9%) serious adverse events were judged as unrelated to the study drug.
3 context sentences(design, population, supporting numbers)
Summary · context
To evaluate the efficacy and tolerability of a once-yearly histrelin implant during an open-label extension of a pivotal study.
Summary · context
Men with advanced prostate cancer and a clinical response to 52 weeks of treatment with the histrelin implant.
Summary · context
Implants were placed annually.
Report a problemFND-2185153910
05HumanNon-randomized trialSafety outcome
During histrelin treatment for advanced prostate cancer, 28 (26.9%) serious adverse events were judged unrelated to the study drug.
In plain wordsDuring histrelin treatment for advanced prostate cancer, serious adverse events were judged unrelated to the drug.
Peptide
Histrelin
Outcome
Not applicableSerious adverse events
Study
n = 104
Analysis
Secondary
Outcome group
Adverse events · Whole body
Studied dose
Dose not stated · subcutaneousAs given in this study (human).
Measurements
Serious adverse events
28 events
judged unrelated to study drug
Serious adverse events
26.9%
judged unrelated to study drug
Source sentences
Summary
The eight deaths and 28 (26.9%) serious adverse events were judged as unrelated to the study drug.
3 context sentences(design, population, supporting numbers)
Summary · context
To evaluate the efficacy and tolerability of a once-yearly histrelin implant during an open-label extension of a pivotal study.
Summary · context
Men with advanced prostate cancer and a clinical response to 52 weeks of treatment with the histrelin implant.
Summary · context
Implants were placed annually.
Report a problemFND-2185153911
06HumanNon-randomized trialSafety outcome
Drug-related hot flashes occurred in 67 men (64.4%) receiving histrelin for advanced prostate cancer, mostly mild or moderate.
In plain wordsDrug-related hot flashes affected 64.4% of men receiving histrelin for advanced prostate cancer, mostly mildly or moderately.
Peptide
Histrelin
Outcome
Not applicableHot flashes
Study
n = 104
Analysis
Secondary
Outcome group
Adverse events · Endocrine and hormones
Studied dose
Dose not stated · subcutaneousAs given in this study (human).
Measurements
Patients with drug-related hot flashes
67 patients
most mild or moderate
Patients with drug-related hot flashes
64.4%
most mild or moderate
Source sentences
Summary
The most commonly reported drug-related adverse events was hot flashes in 67 (64.4%) patients.
4 context sentences(design, population, supporting numbers)
Summary · context
Most of these cases was judged as mild or moderate.
Summary · context
To evaluate the efficacy and tolerability of a once-yearly histrelin implant during an open-label extension of a pivotal study.
Summary · context
Men with advanced prostate cancer and a clinical response to 52 weeks of treatment with the histrelin implant.
Summary · context
Implants were placed annually.
Report a problemFND-2185153912
07HumanNon-randomized trialOther
In men with advanced prostate cancer, histrelin implant placement took a mean 4.5 (SD 6.2) minutes.
In plain wordsIn men with advanced prostate cancer, histrelin implant placement took a mean 4.5 minutes.
Peptide
Histrelin
Outcome
Not applicableImplant placement time
Study
n = 104
Outcome group
Treatment Procedure · Pharmacology
Studied dose
Dose not stated · subcutaneousAs given in this study (human).
Measurements
Mean implant placement time
4.5 min
SD 6.2 min
Source sentences
Summary
Mean (SD) time to place the histrelin implant was 4.5 (6.2) min, with only three patients having insertions that were considered difficult.
3 context sentences(design, population, supporting numbers)
Summary · context
To evaluate the efficacy and tolerability of a once-yearly histrelin implant during an open-label extension of a pivotal study.
Summary · context
Men with advanced prostate cancer and a clinical response to 52 weeks of treatment with the histrelin implant.
Summary · context
Implants were placed annually.
Report a problemFND-2185153907
08HumanNon-randomized trialSafety outcome
Three men with advanced prostate cancer had histrelin implant insertions considered difficult.
In plain wordsThree men with advanced prostate cancer had difficult histrelin implant insertions.
Peptide
Histrelin
Outcome
Not applicableDifficult insertion
Study
n = 104
Outcome group
Adverse events · Whole body
Studied dose
Dose not stated · subcutaneousAs given in this study (human).
Measurements
Patients with difficult insertions
3 patients
insertions considered difficult
Source sentences
Summary
Mean (SD) time to place the histrelin implant was 4.5 (6.2) min, with only three patients having insertions that were considered difficult.
3 context sentences(design, population, supporting numbers)
Summary · context
To evaluate the efficacy and tolerability of a once-yearly histrelin implant during an open-label extension of a pivotal study.
Summary · context
Men with advanced prostate cancer and a clinical response to 52 weeks of treatment with the histrelin implant.
Summary · context
Implants were placed annually.
Report a problemFND-2185153908
09HumanNon-randomized trialEfficacy outcome
In men with advanced prostate cancer receiving histrelin, mean testosterone was 13.1 ng/dL after 104 weeks.
In plain wordsIn men receiving histrelin for advanced prostate cancer, mean testosterone was 13.1 ng/dL after 104 weeks.
Peptide
Histrelin
Outcome
Not applicableMean testosterone at year 2
Study
n: not reported in source
Outcome group
Sex hormones and fertility · Endocrine and hormones
Studied dose
Dose not stated · subcutaneous · 104 weeksAs given in this study (human).
Measurements
Mean serum testosterone
13.1 ng/dL
104 weeks (year 2)
Source sentences
Summary
Serum testosterone was consistently suppressed below 50 ng/dL in all patients and mean testosterone levels were 13.1, 14.8 and 10.8 ng/dL after 104 weeks (year 2), 156 weeks (year 3) and 208 weeks (year 4) of treatment, respectively.
3 context sentences(design, population, supporting numbers)
Summary · context
To evaluate the efficacy and tolerability of a once-yearly histrelin implant during an open-label extension of a pivotal study.
Summary · context
Men with advanced prostate cancer and a clinical response to 52 weeks of treatment with the histrelin implant.
Summary · context
Implants were placed annually.
Report a problemFND-2185153903
10HumanNon-randomized trialEfficacy outcome
In men with advanced prostate cancer receiving histrelin, mean testosterone was 14.8 ng/dL after 156 weeks.
In plain wordsIn men receiving histrelin for advanced prostate cancer, mean testosterone was 14.8 ng/dL after 156 weeks.
Peptide
Histrelin
Outcome
Not applicableMean testosterone at year 3
Study
n: not reported in source
Outcome group
Sex hormones and fertility · Endocrine and hormones
Studied dose
Dose not stated · subcutaneous · 156 weeksAs given in this study (human).
Measurements
Mean serum testosterone
14.8 ng/dL
156 weeks (year 3)
Source sentences
Summary
Serum testosterone was consistently suppressed below 50 ng/dL in all patients and mean testosterone levels were 13.1, 14.8 and 10.8 ng/dL after 104 weeks (year 2), 156 weeks (year 3) and 208 weeks (year 4) of treatment, respectively.
3 context sentences(design, population, supporting numbers)
Summary · context
To evaluate the efficacy and tolerability of a once-yearly histrelin implant during an open-label extension of a pivotal study.
Summary · context
Men with advanced prostate cancer and a clinical response to 52 weeks of treatment with the histrelin implant.
Summary · context
Implants were placed annually.
Report a problemFND-2185153904
11HumanNon-randomized trialEfficacy outcome
In men with advanced prostate cancer receiving histrelin, mean testosterone was 10.8 ng/dL after 208 weeks.
In plain wordsIn men receiving histrelin for advanced prostate cancer, mean testosterone was 10.8 ng/dL after 208 weeks.
Peptide
Histrelin
Outcome
Not applicableMean testosterone at year 4
Study
n: not reported in source
Outcome group
Sex hormones and fertility · Endocrine and hormones
Studied dose
Dose not stated · subcutaneous · 208 weeksAs given in this study (human).
Measurements
Mean serum testosterone
10.8 ng/dL
208 weeks (year 4)
Source sentences
Summary
Serum testosterone was consistently suppressed below 50 ng/dL in all patients and mean testosterone levels were 13.1, 14.8 and 10.8 ng/dL after 104 weeks (year 2), 156 weeks (year 3) and 208 weeks (year 4) of treatment, respectively.
3 context sentences(design, population, supporting numbers)
Summary · context
To evaluate the efficacy and tolerability of a once-yearly histrelin implant during an open-label extension of a pivotal study.
Summary · context
Men with advanced prostate cancer and a clinical response to 52 weeks of treatment with the histrelin implant.
Summary · context
Implants were placed annually.
Report a problemFND-2185153905

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Version 2Current
28 Oct 2026, 02:03 UTC
Study results updated
Version 1
27 Oct 2026, 16:35 UTC
First added · source update from Europe PMC

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