Randomized open labelled comparative study of the efficacy, safety and tolerability of leuprorelin acetate 1M and 3M depot in patients with advanced prostatic cancer.

Wechsel HW, Zerbib M, Pagano F, Coptcoat MJ

European urology1 Jan 1996Cited by 30 (Europe PMC)

PMID8977984DOI10.1159/000474238PepBankPUB-08977984

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 study15

15 results from studies that gave the peptide. 15 results from people.

01HumanRandomized controlled trialEfficacy outcome
In advanced or metastatic prostate cancer, testosterone effects were virtually identical with leuprorelin 3M and 1M depots.
In plain wordsIn advanced or metastatic prostate cancer, testosterone effects were similar with leuprorelin 3M and 1M depots.
Peptide
Leuprolide
Outcome
No significant changeTestosterone effects between formulations
Study
n = 237
Comparator
1M depot
Outcome group
Sex hormones and fertility · Endocrine and hormones
Studied dose
Dose not stated · 9 monthsAs given in this study (human).
Source sentences
Summary
The two formulations produced virtually identical effects with a pronounced fall in testosterone and gonadotropin serum levels and a marked reduction in PSA levels.
1 context sentence(design, population, supporting numbers)
Summary · context
In a European, prospective, 1:2 randomized phase II multicentre study, 237 patients with advanced or metastatic prostate cancer were treated with either the 1M- (80 patients) or 3M-depot formulation (157 patients) of leuprorelin acetate for 9 months to compare efficacy and safety.
Report a problemFND-0897798404
02HumanRandomized controlled trialEfficacy outcome
In advanced or metastatic prostate cancer, gonadotropin effects were virtually identical with leuprorelin 3M and 1M depots.
In plain wordsIn advanced or metastatic prostate cancer, gonadotropin effects were similar with leuprorelin 3M and 1M depots.
Peptide
Leuprolide
Outcome
No significant changeGonadotropin effects between formulations
Study
n = 237
Comparator
1M depot
Outcome group
Sex hormones and fertility · Endocrine and hormones
Studied dose
Dose not stated · 9 monthsAs given in this study (human).
Source sentences
Summary
The two formulations produced virtually identical effects with a pronounced fall in testosterone and gonadotropin serum levels and a marked reduction in PSA levels.
1 context sentence(design, population, supporting numbers)
Summary · context
In a European, prospective, 1:2 randomized phase II multicentre study, 237 patients with advanced or metastatic prostate cancer were treated with either the 1M- (80 patients) or 3M-depot formulation (157 patients) of leuprorelin acetate for 9 months to compare efficacy and safety.
Report a problemFND-0897798405
03HumanRandomized controlled trialEfficacy outcome
In advanced or metastatic prostate cancer, PSA effects were virtually identical with leuprorelin 3M and 1M depots.
In plain wordsIn advanced or metastatic prostate cancer, PSA effects were similar with leuprorelin 3M and 1M depots.
Peptide
Leuprolide
Outcome
No significant changePSA effects between formulations
Study
n = 237
Comparator
1M depot
Outcome group
Tumor growth · Cancer
Studied dose
Dose not stated · 9 monthsAs given in this study (human).
Source sentences
Summary
The two formulations produced virtually identical effects with a pronounced fall in testosterone and gonadotropin serum levels and a marked reduction in PSA levels.
1 context sentence(design, population, supporting numbers)
Summary · context
In a European, prospective, 1:2 randomized phase II multicentre study, 237 patients with advanced or metastatic prostate cancer were treated with either the 1M- (80 patients) or 3M-depot formulation (157 patients) of leuprorelin acetate for 9 months to compare efficacy and safety.
Report a problemFND-0897798406
04HumanNon-randomized trialEfficacy outcome
In advanced or metastatic prostate cancer, both leuprorelin depot formulations produced pronounced falls in serum testosterone.
In plain wordsIn advanced or metastatic prostate cancer, both leuprorelin depot formulations lowered serum testosterone from baseline.
Peptide
Leuprolide
Outcome
DecreaseSerum testosterone
Study
n = 237
Comparator
Baseline
Outcome group
Sex hormones and fertility · Endocrine and hormones
Studied dose
Dose not stated · 9 monthsAs given in this study (human).
Source sentences
Summary
The two formulations produced virtually identical effects with a pronounced fall in testosterone and gonadotropin serum levels and a marked reduction in PSA levels.
1 context sentence(design, population, supporting numbers)
Summary · context
In a European, prospective, 1:2 randomized phase II multicentre study, 237 patients with advanced or metastatic prostate cancer were treated with either the 1M- (80 patients) or 3M-depot formulation (157 patients) of leuprorelin acetate for 9 months to compare efficacy and safety.
Report a problemFND-0897798401
05HumanNon-randomized trialEfficacy outcome
In advanced or metastatic prostate cancer, both leuprorelin depot formulations produced pronounced falls in serum gonadotropins.
In plain wordsIn advanced or metastatic prostate cancer, both leuprorelin depot formulations lowered serum gonadotropins from baseline.
Peptide
Leuprolide
Outcome
DecreaseSerum gonadotropins
Study
n = 237
Comparator
Baseline
Outcome group
Sex hormones and fertility · Endocrine and hormones
Studied dose
Dose not stated · 9 monthsAs given in this study (human).
Source sentences
Summary
The two formulations produced virtually identical effects with a pronounced fall in testosterone and gonadotropin serum levels and a marked reduction in PSA levels.
1 context sentence(design, population, supporting numbers)
Summary · context
In a European, prospective, 1:2 randomized phase II multicentre study, 237 patients with advanced or metastatic prostate cancer were treated with either the 1M- (80 patients) or 3M-depot formulation (157 patients) of leuprorelin acetate for 9 months to compare efficacy and safety.
Report a problemFND-0897798402
06HumanNon-randomized trialEfficacy outcome
In advanced or metastatic prostate cancer, both leuprorelin depot formulations markedly reduced PSA levels.
In plain wordsIn advanced or metastatic prostate cancer, both leuprorelin depot formulations lowered PSA levels from baseline.
Peptide
Leuprolide
Outcome
DecreasePSA levels
Study
n = 237
Comparator
Baseline
Outcome group
Tumor growth · Cancer
Studied dose
Dose not stated · 9 monthsAs given in this study (human).
Source sentences
Summary
The two formulations produced virtually identical effects with a pronounced fall in testosterone and gonadotropin serum levels and a marked reduction in PSA levels.
1 context sentence(design, population, supporting numbers)
Summary · context
In a European, prospective, 1:2 randomized phase II multicentre study, 237 patients with advanced or metastatic prostate cancer were treated with either the 1M- (80 patients) or 3M-depot formulation (157 patients) of leuprorelin acetate for 9 months to compare efficacy and safety.
Report a problemFND-0897798403
07HumanNon-randomized trialSafety outcome
In advanced or metastatic prostate cancer, the main side effects of both leuprorelin depot formulations related to androgen deprivation.
In plain wordsIn advanced or metastatic prostate cancer, both leuprorelin depot formulations mainly caused side effects related to androgen deprivation.
Peptide
Leuprolide
Outcome
Not applicableAndrogen-deprivation side effects
Study
n = 237
Outcome group
Adverse events · Cancer
Studied dose
Dose not stated · 9 monthsAs given in this study (human).
Source sentences
Summary
The main side effects of both formulations were related to androgen deprivation.
1 context sentence(design, population, supporting numbers)
Summary · context
In a European, prospective, 1:2 randomized phase II multicentre study, 237 patients with advanced or metastatic prostate cancer were treated with either the 1M- (80 patients) or 3M-depot formulation (157 patients) of leuprorelin acetate for 9 months to compare efficacy and safety.
Report a problemFND-0897798415
08HumanNon-randomized trialEfficacy outcome
In advanced or metastatic prostate cancer, PSA normalized to < or = 4 ng/ml in 65.2% of leuprorelin 1M recipients after 9 months.
In plain wordsIn advanced or metastatic prostate cancer, PSA normalized in 65.2% of leuprorelin 1M recipients after 9 months.
Peptide
Leuprolide
Outcome
Not applicablePSA normalization with 1M depot
Study
n: not reported in source
Outcome group
Tumor growth · Cancer
Studied dose
Dose not stated · 9 monthsAs given in this study (human).
Measurements
PSA normalized (<= 4 ng/ml)
65.2%
1M depot, after 9 months
Source sentences
Summary
After 9 months' treatment, PSA was normalized (< or = 4 ng/ml) in 65.2 and 66.1% of the 1M and 3M depot patients, respectively.
1 context sentence(design, population, supporting numbers)
Summary · context
In a European, prospective, 1:2 randomized phase II multicentre study, 237 patients with advanced or metastatic prostate cancer were treated with either the 1M- (80 patients) or 3M-depot formulation (157 patients) of leuprorelin acetate for 9 months to compare efficacy and safety.
Report a problemFND-0897798407
09HumanNon-randomized trialEfficacy outcome
In advanced or metastatic prostate cancer, PSA normalized to < or = 4 ng/ml in 66.1% of leuprorelin 3M recipients after 9 months.
In plain wordsIn advanced or metastatic prostate cancer, PSA normalized in 66.1% of leuprorelin 3M recipients after 9 months.
Peptide
Leuprolide
Outcome
Not applicablePSA normalization with 3M depot
Study
n: not reported in source
Outcome group
Tumor growth · Cancer
Studied dose
Dose not stated · 9 monthsAs given in this study (human).
Measurements
PSA normalized (<= 4 ng/ml)
66.1%
3M depot, after 9 months
Source sentences
Summary
After 9 months' treatment, PSA was normalized (< or = 4 ng/ml) in 65.2 and 66.1% of the 1M and 3M depot patients, respectively.
1 context sentence(design, population, supporting numbers)
Summary · context
In a European, prospective, 1:2 randomized phase II multicentre study, 237 patients with advanced or metastatic prostate cancer were treated with either the 1M- (80 patients) or 3M-depot formulation (157 patients) of leuprorelin acetate for 9 months to compare efficacy and safety.
Report a problemFND-0897798408
10HumanNon-randomized trialEfficacy outcome
In advanced or metastatic prostate cancer, best response was complete remission in 5% with leuprorelin 1M depot.
In plain wordsIn advanced or metastatic prostate cancer, complete remission was the best response in 5% with leuprorelin 1M depot.
Peptide
Leuprolide
Outcome
Not applicableComplete remission with 1M depot
Study
n: not reported in source
Outcome group
Tumor growth · Cancer
Studied dose
Dose not stated · 9 monthsAs given in this study (human).
Measurements
Best response: complete remission
5%
1M depot
Source sentences
Summary
The best response to 1M vs. 3M depot during the study was as follows: complete remission in 5 vs. 5.7%, partial remission in 36.3 vs. 33.8% and stabilization in 40.0 vs. 40.8%.
1 context sentence(design, population, supporting numbers)
Summary · context
In a European, prospective, 1:2 randomized phase II multicentre study, 237 patients with advanced or metastatic prostate cancer were treated with either the 1M- (80 patients) or 3M-depot formulation (157 patients) of leuprorelin acetate for 9 months to compare efficacy and safety.
Report a problemFND-0897798409
11HumanNon-randomized trialEfficacy outcome
In advanced or metastatic prostate cancer, best response was complete remission in 5.7% with leuprorelin 3M depot.
In plain wordsIn advanced or metastatic prostate cancer, complete remission was the best response in 5.7% with leuprorelin 3M depot.
Peptide
Leuprolide
Outcome
Not applicableComplete remission with 3M depot
Study
n: not reported in source
Outcome group
Tumor growth · Cancer
Studied dose
Dose not stated · 9 monthsAs given in this study (human).
Measurements
Best response: complete remission
5.7%
3M depot
Source sentences
Summary
The best response to 1M vs. 3M depot during the study was as follows: complete remission in 5 vs. 5.7%, partial remission in 36.3 vs. 33.8% and stabilization in 40.0 vs. 40.8%.
1 context sentence(design, population, supporting numbers)
Summary · context
In a European, prospective, 1:2 randomized phase II multicentre study, 237 patients with advanced or metastatic prostate cancer were treated with either the 1M- (80 patients) or 3M-depot formulation (157 patients) of leuprorelin acetate for 9 months to compare efficacy and safety.
Report a problemFND-0897798410
12HumanNon-randomized trialEfficacy outcome
In advanced or metastatic prostate cancer, best response was partial remission in 36.3% with leuprorelin 1M depot.
In plain wordsIn advanced or metastatic prostate cancer, partial remission was the best response in 36.3% with leuprorelin 1M depot.
Peptide
Leuprolide
Outcome
Not applicablePartial remission with 1M depot
Study
n: not reported in source
Outcome group
Tumor growth · Cancer
Studied dose
Dose not stated · 9 monthsAs given in this study (human).
Measurements
Best response: partial remission
36.3%
1M depot
Source sentences
Summary
The best response to 1M vs. 3M depot during the study was as follows: complete remission in 5 vs. 5.7%, partial remission in 36.3 vs. 33.8% and stabilization in 40.0 vs. 40.8%.
1 context sentence(design, population, supporting numbers)
Summary · context
In a European, prospective, 1:2 randomized phase II multicentre study, 237 patients with advanced or metastatic prostate cancer were treated with either the 1M- (80 patients) or 3M-depot formulation (157 patients) of leuprorelin acetate for 9 months to compare efficacy and safety.
Report a problemFND-0897798411
13HumanNon-randomized trialEfficacy outcome
In advanced or metastatic prostate cancer, best response was partial remission in 33.8% with leuprorelin 3M depot.
In plain wordsIn advanced or metastatic prostate cancer, partial remission was the best response in 33.8% with leuprorelin 3M depot.
Peptide
Leuprolide
Outcome
Not applicablePartial remission with 3M depot
Study
n: not reported in source
Outcome group
Tumor growth · Cancer
Studied dose
Dose not stated · 9 monthsAs given in this study (human).
Measurements
Best response: partial remission
33.8%
3M depot
Source sentences
Summary
The best response to 1M vs. 3M depot during the study was as follows: complete remission in 5 vs. 5.7%, partial remission in 36.3 vs. 33.8% and stabilization in 40.0 vs. 40.8%.
1 context sentence(design, population, supporting numbers)
Summary · context
In a European, prospective, 1:2 randomized phase II multicentre study, 237 patients with advanced or metastatic prostate cancer were treated with either the 1M- (80 patients) or 3M-depot formulation (157 patients) of leuprorelin acetate for 9 months to compare efficacy and safety.
Report a problemFND-0897798412
14HumanNon-randomized trialEfficacy outcome
In advanced or metastatic prostate cancer, best response was stabilization in 40.0% with leuprorelin 1M depot.
In plain wordsIn advanced or metastatic prostate cancer, stabilization was the best response in 40.0% with leuprorelin 1M depot.
Peptide
Leuprolide
Outcome
Not applicableStabilization with 1M depot
Study
n: not reported in source
Outcome group
Tumor growth · Cancer
Studied dose
Dose not stated · 9 monthsAs given in this study (human).
Measurements
Best response: stabilization
40%
1M depot
Source sentences
Summary
The best response to 1M vs. 3M depot during the study was as follows: complete remission in 5 vs. 5.7%, partial remission in 36.3 vs. 33.8% and stabilization in 40.0 vs. 40.8%.
1 context sentence(design, population, supporting numbers)
Summary · context
In a European, prospective, 1:2 randomized phase II multicentre study, 237 patients with advanced or metastatic prostate cancer were treated with either the 1M- (80 patients) or 3M-depot formulation (157 patients) of leuprorelin acetate for 9 months to compare efficacy and safety.
Report a problemFND-0897798413
15HumanNon-randomized trialEfficacy outcome
In advanced or metastatic prostate cancer, best response was stabilization in 40.8% with leuprorelin 3M depot.
In plain wordsIn advanced or metastatic prostate cancer, stabilization was the best response in 40.8% with leuprorelin 3M depot.
Peptide
Leuprolide
Outcome
Not applicableStabilization with 3M depot
Study
n: not reported in source
Outcome group
Tumor growth · Cancer
Studied dose
Dose not stated · 9 monthsAs given in this study (human).
Measurements
Best response: stabilization
40.8%
3M depot
Source sentences
Summary
The best response to 1M vs. 3M depot during the study was as follows: complete remission in 5 vs. 5.7%, partial remission in 36.3 vs. 33.8% and stabilization in 40.0 vs. 40.8%.
1 context sentence(design, population, supporting numbers)
Summary · context
In a European, prospective, 1:2 randomized phase II multicentre study, 237 patients with advanced or metastatic prostate cancer were treated with either the 1M- (80 patients) or 3M-depot formulation (157 patients) of leuprorelin acetate for 9 months to compare efficacy and safety.
Report a problemFND-0897798414

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, 16:37 UTC
First added · source update from Europe PMC

Subjects

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