Efficacy and safety of histrelin subdermal implant in patients with advanced prostate cancer.

Schlegel PN

The Journal of urology1 Apr 2006Cited by 39 (Europe PMC)

PMID16515997DOI10.1016/s0022-5347(05)00649-xPepBankPUB-16515997

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 study8

8 results from studies that gave the peptide. 8 results from people.

01HumanNon-randomized trialEfficacy outcome
In men with advanced prostate cancer, PSA decreased by an average of 90% from 83.6 ng/ml by week 16 with histrelin (p = 0.0001).
In plain wordsIn men with advanced prostate cancer, PSA decreased by an average of 90% by week 16 with histrelin.
Peptide
Histrelin
Outcome
DecreasePSA decrease at week 16
Study
n: not reported in source
Analysis
Secondary
Outcome group
Tumor growth · Cancer
Studied dose
50 mg · subdermal implantAs given in this study (human).
Measurements
Average PSA decrease by week 16
90%
from baseline
Baseline PSA
83.6 ng/ml
baseline
Source sentences
Summary
By week 16 PSA had decreased an average of 90% from a baseline of 83.6 ng/ml (p = 0.0001).
1 context sentence(design, population, supporting numbers)
Summary · context
This open label, multicenter study was done to evaluate the efficacy and safety of the gonadotropin hormone-releasing hormone agonist histrelin acetate administered as a 50 mg subdermal implant in men with advanced prostatic cancer.
Report a problemFND-1651599704
02HumanNon-randomized trialEfficacy outcome
In men with advanced prostate cancer, 79% had a complete PSA response by week 60 with histrelin (p <0.0175).
In plain wordsIn men with advanced prostate cancer, 79% had a complete PSA response by week 60 with histrelin.
Peptide
Histrelin
Outcome
Not applicableComplete PSA response
Study
n: not reported in source
Analysis
Secondary
Outcome group
Tumor growth · Cancer
Studied dose
50 mg · subdermal implantAs given in this study (human).
Measurements
Patients with complete PSA response by week 60
79%
patients
Source sentences
Summary
By week 60, 79% of patients had a complete PSA response (p <0.0175).
1 context sentence(design, population, supporting numbers)
Summary · context
This open label, multicenter study was done to evaluate the efficacy and safety of the gonadotropin hormone-releasing hormone agonist histrelin acetate administered as a 50 mg subdermal implant in men with advanced prostatic cancer.
Report a problemFND-1651599705
03HumanNon-randomized trialEfficacy outcome
In men with advanced prostate cancer receiving histrelin, 100% of 134 evaluable patients achieved chemical castration at week 4.
In plain wordsAll 134 men with available results achieved chemical castration at week 4 with histrelin.
Peptide
Histrelin
Outcome
Not applicableChemical castration at week 4
Study
n = 134
Outcome group
Sex hormones and fertility · Endocrine and hormones
Studied dose
50 mg · subdermal implantAs given in this study (human).
Measurements
Patients achieving chemical castration at week 4
100%
134 patients with week 4 testosterone levels
Source sentences
Summary
Of the 134 patients with week 4 testosterone levels available 100% achieved chemical castration.
2 context sentences(design, population, supporting numbers)
Summary · context
Efficacy was determined by the proportion of patients who attained chemical castration (serum testosterone 50 ng/dl or less) at weeks 4 through 52.
Summary · context
This open label, multicenter study was done to evaluate the efficacy and safety of the gonadotropin hormone-releasing hormone agonist histrelin acetate administered as a 50 mg subdermal implant in men with advanced prostatic cancer.
Report a problemFND-1651599701
04HumanNon-randomized trialEfficacy outcome
In men with advanced prostate cancer, histrelin maintained testosterone suppression through 52 weeks in more than 99% of patients.
In plain wordsHistrelin maintained testosterone suppression through 52 weeks in more than 99% of men with advanced prostate cancer.
Peptide
Histrelin
Outcome
Not applicableTestosterone suppression through week 52
Study
n: not reported in source
Outcome group
Sex hormones and fertility · Endocrine and hormones
Studied dose
50 mg · subdermal implantAs given in this study (human).
Measurements
Patients with testosterone suppression maintained through 52 weeks
> 99%
patients after implantation
Source sentences
Summary
Testosterone suppression was maintained throughout the 52 weeks after implantation in more than 99% of patients.
1 context sentence(design, population, supporting numbers)
Summary · context
This open label, multicenter study was done to evaluate the efficacy and safety of the gonadotropin hormone-releasing hormone agonist histrelin acetate administered as a 50 mg subdermal implant in men with advanced prostatic cancer.
Report a problemFND-1651599702
05HumanNon-randomized trialEfficacy outcome
In men with advanced prostate cancer, histrelin significantly suppressed LH.
In plain wordsIn men with advanced prostate cancer, histrelin suppressed LH.
Peptide
Histrelin
Outcome
DecreaseLH suppression
Study
n: not reported in source
Outcome group
Sex hormones and fertility · Endocrine and hormones
Studied dose
50 mg · subdermal implantAs given in this study (human).
Source sentences
Summary
Significant LH and PSA suppression was also observed.
1 context sentence(design, population, supporting numbers)
Summary · context
This open label, multicenter study was done to evaluate the efficacy and safety of the gonadotropin hormone-releasing hormone agonist histrelin acetate administered as a 50 mg subdermal implant in men with advanced prostatic cancer.
Report a problemFND-1651599703
06HumanNon-randomized trialSafety outcome
In men with advanced prostate cancer, no testosterone surge occurred with histrelin reimplantation.
In plain wordsIn men with advanced prostate cancer, no testosterone surge occurred with histrelin reimplantation.
Peptide
Histrelin
Outcome
Not applicableTestosterone surge on reimplantation
Study
n: not reported in source
Outcome group
Sex hormones and fertility · Endocrine and hormones
Studied dose
50 mg · subdermal implantAs given in this study (human).
Source sentences
Summary
No testosterone or LH surge was observed with reimplantation.
1 context sentence(design, population, supporting numbers)
Summary · context
This open label, multicenter study was done to evaluate the efficacy and safety of the gonadotropin hormone-releasing hormone agonist histrelin acetate administered as a 50 mg subdermal implant in men with advanced prostatic cancer.
Report a problemFND-1651599706
07HumanNon-randomized trialSafety outcome
In men with advanced prostate cancer, no LH surge occurred with histrelin reimplantation.
In plain wordsIn men with advanced prostate cancer, no LH surge occurred with histrelin reimplantation.
Peptide
Histrelin
Outcome
Not applicableLH surge on reimplantation
Study
n: not reported in source
Outcome group
Sex hormones and fertility · Endocrine and hormones
Studied dose
50 mg · subdermal implantAs given in this study (human).
Source sentences
Summary
No testosterone or LH surge was observed with reimplantation.
1 context sentence(design, population, supporting numbers)
Summary · context
This open label, multicenter study was done to evaluate the efficacy and safety of the gonadotropin hormone-releasing hormone agonist histrelin acetate administered as a 50 mg subdermal implant in men with advanced prostatic cancer.
Report a problemFND-1651599707
08HumanNon-randomized trialSafety outcome
In men with advanced prostate cancer, the histrelin implant was described as safe and well tolerated.
In plain wordsIn men with advanced prostate cancer, the histrelin implant was described as safe and well tolerated.
Peptide
Histrelin
Outcome
Not applicableTolerability
Study
n: not reported in source
Outcome group
Adverse events · Whole body
Studied dose
50 mg · subdermal implantAs given in this study (human).
Source sentences
Summary
Additionally, the implant was safe and well tolerated.
1 context sentence(design, population, supporting numbers)
Summary · context
This open label, multicenter study was done to evaluate the efficacy and safety of the gonadotropin hormone-releasing hormone agonist histrelin acetate administered as a 50 mg subdermal implant in men with advanced prostatic cancer.
Report a problemFND-1651599708

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

Registered trials1

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

1 trial · 1 completed · source ClinicalTrials.gov (opens in a new tab)

CompletedPhase 3NCT01697384

Study to Evaluate Efficacy and Safety of Histrelin Subdermal Implant in Men With Advanced Prostate Cancer

Endo USA Inc., a Keenova Therapeutics Companyn = 138Apr 2000 to Oct 2004

Prostate Cancer · Adenocarcinoma of the Prostate

Trial page ClinicalTrials.govUpdated 2 Jan 2024

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, 16:35 UTC
First added · source update from Europe PMC

Subjects

Terms as the source lists them.

Publication types

MeSH terms

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