Clinical study of leuprolide depot formulation in the treatment of advanced prostate cancer. The Leuprolide Study Group.

Sharifi R, Soloway M

The Journal of urology1 Jan 1990Cited by 75 (Europe PMC)

PMID2104638DOI10.1016/s0022-5347(17)39868-3PepBankPUB-02104638

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 trialSafety outcome
In patients with stage D2 prostate cancer, related or unrelated adverse events occurred in 45 of 56 depot leuprolide patients.
In plain wordsIn patients with advanced prostate cancer, 45 of 56 patients reported adverse events during depot leuprolide treatment.
Peptide
Leuprolide
Outcome
Not applicableAdverse events
Study
n = 56
Outcome group
Adverse events · Cancer
Studied dose
7.5 mg every 4 weeks · intramuscularAs given in this study (human).
Measurements
Patients with adverse events
45 patients
56 patients
Source sentences
Summary
Objective response (no progression) to treatment occurred in 81% of 53 evaluable patients and adverse (related and unrelated) events were reported in 45 of the 56 patients.
1 context sentence(design, population, supporting numbers)
Summary · context
In a phase III, open, multicenter study we evaluated the safety and efficacy of the depot formulation of leuprolide (7.5 mg. injected intramuscularly every 4 weeks) in patients with stage D2 prostate cancer who had not previously received systemic treatment.
Report a problemFND-0210463806
02HumanNon-randomized trialEfficacy outcome
In patients with stage D2 prostate cancer, 81% of 53 evaluable patients had no progression with depot leuprolide.
In plain wordsIn patients with advanced prostate cancer, 81% of evaluable patients had no progression with depot leuprolide.
Peptide
Leuprolide
Outcome
Not applicableObjective response without progression
Study
n = 53
Outcome group
Tumor response · Cancer
Studied dose
7.5 mg every 4 weeks · intramuscularAs given in this study (human).
Measurements
Objective response
81%
53 evaluable patients
Source sentences
Summary
Objective response (no progression) to treatment occurred in 81% of 53 evaluable patients and adverse (related and unrelated) events were reported in 45 of the 56 patients.
1 context sentence(design, population, supporting numbers)
Summary · context
In a phase III, open, multicenter study we evaluated the safety and efficacy of the depot formulation of leuprolide (7.5 mg. injected intramuscularly every 4 weeks) in patients with stage D2 prostate cancer who had not previously received systemic treatment.
Report a problemFND-0210463805
03HumanNon-randomized trialEfficacy outcome
In patients with stage D2 prostate cancer, median time to castrate testosterone with depot leuprolide was 21 days.
In plain wordsIn patients with advanced prostate cancer, the median time to castrate testosterone with depot leuprolide was 21 days.
Peptide
Leuprolide
Outcome
Not applicableTime to castrate testosterone
Study
n: not reported in source
Outcome group
Sex hormones and fertility · Cancer
Studied dose
7.5 mg every 4 weeks · intramuscularAs given in this study (human).
Measurements
Median interval
21 days
onset of castrate testosterone
Source sentences
Summary
Median interval to onset of castrate testosterone levels was 21 days and mean testosterone levels decreased to within the castrate range by week 3 of treatment.
1 context sentence(design, population, supporting numbers)
Summary · context
In a phase III, open, multicenter study we evaluated the safety and efficacy of the depot formulation of leuprolide (7.5 mg. injected intramuscularly every 4 weeks) in patients with stage D2 prostate cancer who had not previously received systemic treatment.
Report a problemFND-0210463801
04HumanNon-randomized trialEfficacy outcome
In patients with stage D2 prostate cancer, mean testosterone decreased into the castrate range by week 3 with depot leuprolide.
In plain wordsIn patients with advanced prostate cancer, mean testosterone reached the castrate range by week 3 with depot leuprolide.
Peptide
Leuprolide
Outcome
DecreaseMean testosterone
Study
n: not reported in source
Outcome group
Sex hormones and fertility · Cancer
Studied dose
7.5 mg every 4 weeks · intramuscularAs given in this study (human).
Source sentences
Summary
Median interval to onset of castrate testosterone levels was 21 days and mean testosterone levels decreased to within the castrate range by week 3 of treatment.
1 context sentence(design, population, supporting numbers)
Summary · context
In a phase III, open, multicenter study we evaluated the safety and efficacy of the depot formulation of leuprolide (7.5 mg. injected intramuscularly every 4 weeks) in patients with stage D2 prostate cancer who had not previously received systemic treatment.
Report a problemFND-0210463802
05HumanNon-randomized trialEfficacy outcome
In stage D2 prostate cancer, no testosterone escapes, defined as 2 consecutive values above 50 ng./dl., occurred after castration during 24 weeks.
In plain wordsIn patients with advanced prostate cancer, testosterone did not escape the castrate range after suppression began with depot leuprolide.
Peptide
Leuprolide
Outcome
Not applicableTestosterone escapes
Study
n: not reported in source
Outcome group
Sex hormones and fertility · Cancer
Studied dose
7.5 mg every 4 weeks · intramuscular · 24 weeksAs given in this study (human).
Measurements
Testosterone escape threshold
50 ng./dl.
2 consecutive values above threshold
Source sentences
Summary
After onset of castrate levels there were no escapes (defined as 2 consecutive values of greater than 50 ng./dl.) of testosterone levels during the 24 weeks.
1 context sentence(design, population, supporting numbers)
Summary · context
In a phase III, open, multicenter study we evaluated the safety and efficacy of the depot formulation of leuprolide (7.5 mg. injected intramuscularly every 4 weeks) in patients with stage D2 prostate cancer who had not previously received systemic treatment.
Report a problemFND-0210463803
06HumanNon-randomized trialEfficacy outcome
In patients with prostate cancer, testosterone suppression did not differ significantly between depot leuprolide and daily leuprolide in another study.
In plain wordsIn patients with prostate cancer, testosterone suppression was similar with depot leuprolide and daily leuprolide from another study.
Peptide
Leuprolide
Outcome
No significant changeTestosterone suppression versus daily formulation
Study
n: not reported in source
Comparator
Daily subcutaneous leuprolide in another study
Outcome group
Sex hormones and fertility · Cancer
Studied dose
7.5 mg every 4 weeks · intramuscular · 24 weeksAs given in this study (human).
Source sentences
Summary
Suppression of testosterone did not differ significantly from that observed in patients receiving the daily subcutaneous injection of leuprolide acetate in the first 24 weeks of another study.
1 context sentence(design, population, supporting numbers)
Summary · context
In a phase III, open, multicenter study we evaluated the safety and efficacy of the depot formulation of leuprolide (7.5 mg. injected intramuscularly every 4 weeks) in patients with stage D2 prostate cancer who had not previously received systemic treatment.
Report a problemFND-0210463804
07HumanNon-randomized trialEfficacy outcome
In patients with prostate cancer, response rates did not differ significantly between depot leuprolide and daily subcutaneous leuprolide in another study.
In plain wordsIn patients with prostate cancer, response rates did not differ significantly between depot leuprolide and daily leuprolide in another study.
Peptide
Leuprolide
Outcome
No significant changeResponse rate versus daily formulation
Study
n: not reported in source
Comparator
Daily subcutaneous leuprolide in another study
Outcome group
Tumor response · Cancer
Studied dose
7.5 mg every 4 weeks · intramuscularAs given in this study (human).
Source sentences
Summary
The response rate and incidence of adverse events in this study did not differ significantly from those occurring with the daily formulation.
2 context sentences(design, population, supporting numbers)
Summary · context
Suppression of testosterone did not differ significantly from that observed in patients receiving the daily subcutaneous injection of leuprolide acetate in the first 24 weeks of another study.
Summary · context
In a phase III, open, multicenter study we evaluated the safety and efficacy of the depot formulation of leuprolide (7.5 mg. injected intramuscularly every 4 weeks) in patients with stage D2 prostate cancer who had not previously received systemic treatment.
Report a problemFND-0210463807
08HumanNon-randomized trialSafety outcome
In patients with prostate cancer, adverse event incidence did not differ significantly between depot leuprolide and daily subcutaneous leuprolide in another study.
In plain wordsIn patients with prostate cancer, adverse event rates did not differ significantly between depot leuprolide and daily leuprolide in another study.
Peptide
Leuprolide
Outcome
No significant changeAdverse event incidence versus daily formulation
Study
n: not reported in source
Comparator
Daily subcutaneous leuprolide in another study
Outcome group
Adverse events · Cancer
Studied dose
7.5 mg every 4 weeks · intramuscularAs given in this study (human).
Source sentences
Summary
The response rate and incidence of adverse events in this study did not differ significantly from those occurring with the daily formulation.
2 context sentences(design, population, supporting numbers)
Summary · context
Suppression of testosterone did not differ significantly from that observed in patients receiving the daily subcutaneous injection of leuprolide acetate in the first 24 weeks of another study.
Summary · context
In a phase III, open, multicenter study we evaluated the safety and efficacy of the depot formulation of leuprolide (7.5 mg. injected intramuscularly every 4 weeks) in patients with stage D2 prostate cancer who had not previously received systemic treatment.
Report a problemFND-0210463808

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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

Terms as the source lists them.

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