Triptorelin 6-month formulation in the management of patients with locally advanced and metastatic prostate cancer: an open-label, non-comparative, multicentre, phase III study.

Lundström EA, Rencken RK, van Wyk JH, Coetzee LJ, Bahlmann JC, Reif S, Strasheim EA, Bigalke MC, Pontin AR, Goedhals L, Steyn DG, Heyns CF and 5 more

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Aldera LA, Mackenzie TM, Purcea D, Grosgurin PY, Porchet HC

Clinical drug investigation1 Jan 2009Cited by 46 (Europe PMC)

PMID19888782DOI10.2165/11319690-000000000-00000PepBankPUB-19888782

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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 advanced prostate cancer, 97.5% of patients achieved castrate testosterone by day 29 with triptorelin, with 95% CI 92.9-99.5%.
In plain wordsIn advanced prostate cancer, 97.5% of patients achieved castrate testosterone by day 29 with triptorelin.
Peptide
Triptorelin (Trelstar, Decapeptyl)
Outcome
Not applicableCastrate testosterone by day 29
Study
n = 120
Analysis
Primary
Outcome group
Sex hormones and fertility · Endocrine and hormones
Studied dose
22.5 mg twice at an interval of 24 weeks · intramuscular · 48 weeksAs given in this study (human).
Measurements
Patients with castrate testosterone by day 29
97.5%
triptorelin 6-month formulation, intent-to-treat
Patients with castrate testosterone by day 29 95% CI lower limit
92.9%
triptorelin 6-month formulation, intent-to-treat
Patients with castrate testosterone by day 29 95% CI upper limit
99.5%
triptorelin 6-month formulation, intent-to-treat
Source sentences
Summary
In the intent-to-treat population, 97.5% (95% CI 92.9, 99.5) of patients achieved castrate serum testosterone levels by day 29, and 93.0% (95% CI 86.8, 97.0) maintained castration at months 2-12.
3 context sentences(design, population, supporting numbers)
Summary · context
The primary objective was to evaluate the formulation in achieving castrate serum testosterone levels (< or = 1.735 nmol/L or < or = 50 ng/dL) on day 29 and in maintaining castration at months 2-12.
Summary · context
An open-label, non-comparative, phase III study in 120 patients with advanced prostate cancer was conducted from July 2006 to August 2007 in private and public institutions in South Africa.
Summary · context
Each patient received two consecutive intramuscular injections of triptorelin embonate (pamoate) 22.5 mg at an interval of 24 weeks.
Report a problemFND-1988878201
02HumanNon-randomized trialEfficacy outcome
In advanced prostate cancer, 93.0% maintained castration at months 2-12 with triptorelin, with 95% CI 86.8-97.0%.
In plain wordsIn advanced prostate cancer, 93.0% maintained castration at months 2-12 with triptorelin.
Peptide
Triptorelin (Trelstar, Decapeptyl)
Outcome
Not applicableMaintained castration at months 2-12
Study
n = 120
Analysis
Primary
Outcome group
Sex hormones and fertility · Endocrine and hormones
Studied dose
22.5 mg twice at an interval of 24 weeks · intramuscular · 48 weeksAs given in this study (human).
Measurements
Patients maintaining castration at months 2-12
93%
triptorelin 6-month formulation, intent-to-treat
Patients maintaining castration at months 2-12 95% CI lower limit
86.8%
triptorelin 6-month formulation, intent-to-treat
Patients maintaining castration at months 2-12 95% CI upper limit
97%
triptorelin 6-month formulation, intent-to-treat
Source sentences
Summary
In the intent-to-treat population, 97.5% (95% CI 92.9, 99.5) of patients achieved castrate serum testosterone levels by day 29, and 93.0% (95% CI 86.8, 97.0) maintained castration at months 2-12.
3 context sentences(design, population, supporting numbers)
Summary · context
The primary objective was to evaluate the formulation in achieving castrate serum testosterone levels (< or = 1.735 nmol/L or < or = 50 ng/dL) on day 29 and in maintaining castration at months 2-12.
Summary · context
An open-label, non-comparative, phase III study in 120 patients with advanced prostate cancer was conducted from July 2006 to August 2007 in private and public institutions in South Africa.
Summary · context
Each patient received two consecutive intramuscular injections of triptorelin embonate (pamoate) 22.5 mg at an interval of 24 weeks.
Report a problemFND-1988878202
03HumanNon-randomized trialEfficacy outcome
In advanced prostate cancer, 98.3% of patients showed no LH stimulation after the second triptorelin injection.
In plain wordsIn advanced prostate cancer, 98.3% of patients showed no LH stimulation after the second triptorelin injection.
Peptide
Triptorelin (Trelstar, Decapeptyl)
Outcome
Not applicableAbsence of LH stimulation
Study
n = 120
Outcome group
Sex hormones and fertility · Endocrine and hormones
Studied dose
22.5 mg twice at an interval of 24 weeks · intramuscular · 48 weeksAs given in this study (human).
Measurements
Patients with absence of LH stimulation
98.3%
after second triptorelin injection
Source sentences
Summary
After the second injection, 98.3% of patients showed absence of LH stimulation.
2 context sentences(design, population, supporting numbers)
Summary · context
An open-label, non-comparative, phase III study in 120 patients with advanced prostate cancer was conducted from July 2006 to August 2007 in private and public institutions in South Africa.
Summary · context
Each patient received two consecutive intramuscular injections of triptorelin embonate (pamoate) 22.5 mg at an interval of 24 weeks.
Report a problemFND-1988878203
04HumanNon-randomized trialSafety outcome
In advanced prostate cancer, drug-related hot flushes occurred in 71.7% of patients receiving triptorelin.
In plain wordsIn advanced prostate cancer, drug-related hot flushes occurred in 71.7% of patients receiving triptorelin.
Peptide
Triptorelin (Trelstar, Decapeptyl)
Outcome
Not applicableHot flushes
Study
n = 120
Outcome group
Adverse events · Whole body
Studied dose
22.5 mg twice at an interval of 24 weeks · intramuscular · 48 weeksAs given in this study (human).
Measurements
Drug-related hot flushes
71.7%
patients receiving triptorelin
Source sentences
Summary
The most frequent drug-related adverse events were hot flushes (71.7% of patients).
2 context sentences(design, population, supporting numbers)
Summary · context
An open-label, non-comparative, phase III study in 120 patients with advanced prostate cancer was conducted from July 2006 to August 2007 in private and public institutions in South Africa.
Summary · context
Each patient received two consecutive intramuscular injections of triptorelin embonate (pamoate) 22.5 mg at an interval of 24 weeks.
Report a problemFND-1988878204
05HumanNon-randomized trialSafety outcome
In advanced prostate cancer, no patient withdrew from the triptorelin study because of an adverse event.
In plain wordsIn advanced prostate cancer, no patient withdrew from the triptorelin study because of an adverse event.
Peptide
Triptorelin (Trelstar, Decapeptyl)
Outcome
Not applicableWithdrawal due to adverse events
Study
n = 120
Outcome group
Adverse events · Whole body
Studied dose
22.5 mg twice at an interval of 24 weeks · intramuscular · 48 weeksAs given in this study (human).
Source sentences
Summary
No patient withdrew from the study as a result of an adverse event.
2 context sentences(design, population, supporting numbers)
Summary · context
An open-label, non-comparative, phase III study in 120 patients with advanced prostate cancer was conducted from July 2006 to August 2007 in private and public institutions in South Africa.
Summary · context
Each patient received two consecutive intramuscular injections of triptorelin embonate (pamoate) 22.5 mg at an interval of 24 weeks.
Report a problemFND-1988878205

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 · 1 with posted results · source ClinicalTrials.gov (opens in a new tab)

CompletedPhase 3Results postedNCT00751790

Efficacy and Safety of a Triptorelin 6-month Formulation in Patients With Advanced Prostate Cancer

Debiopharm International SAn = 120Jul 2006 to Aug 2007

Prostatic Neoplasm

Trial page ClinicalTrials.govUpdated 25 Jul 2014

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
22 Oct 2026, 02:26 UTC
Study results updated
Version 1
21 Oct 2026, 18:59 UTC
First added · source update from Europe PMC

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Terms as the source lists them.

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