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← Malignant Prostate Neoplasm

NCT02234115 · STUDY IN CONTEXT

Safety, Efficacy, and Pharmacokinetic Behavior of Leuprolide Mesylate in Subjects With Advanced Prostate Carcinoma

Draft scope assessment: narrower. Linked by condition-string match at the cancer-entity level. The study's eligibility - stage, biomarker, treatment line and prior therapy - has not been reconciled against this page's definition, so its population is narrower than this page in ways not yet recorded. The condition was transformed or resolved through the terminology hierarchy to reach this cancer type, so the link itself is a candidate a reviewer must confirm. Found because this study's registry identifier is printed in an FDA approval notice, an FDA product label or an NCI summary held by this site. The citing document and the exact position of the identifier inside it are recorded. Being cited is not a statement that the study supports this treatment.

Read the full study record and all posted results →

Linked outcomes

Measures are not ranked. Open each original source section for treatment groups, denominators, units and results.

primary · POSTED

The percentage of subjects with a serum testosterone concentration suppressed to castrate levels (≤ 50 ng/dL) following the first injection of LMIS 50 mg from Day 28 through Day 336 (remaining duration of the study).

ITT

→

secondary · POSTED

Safety analysis was based on the safety information from the laboratory evaluations, AEs, and SAEs.

Safety population

→

Reported safety

Serious events are not the same as severe events. Compare the original safety groups and their at-risk populations.

Open the study safety table →

Quality of life and patient-reported measures

No linked quality-of-life measure is recorded for this setting and study.

Full draft applicability and source-link record
trial
release id
clinical-indications-draft-1
disease state id
ds-malignant-prostate-neoplasm
nct id
NCT02234115
trial label
Safety, Efficacy, and Pharmacokinetic Behavior of Leuprolide Mesylate in Subjects With Advanced Prostate Carcinoma
applicability
narrower
applicability note
Linked by condition-string match at the cancer-entity level. The study's eligibility - stage, biomarker, treatment line and prior therapy - has not been reconciled against this page's definition, so its population is narrower than this page in ways not yet recorded. The condition was transformed or resolved through the terminology hierarchy to reach this cancer type, so the link itself is a candidate a reviewer must confirm.
curation status
draft
reviewed by
Source null
reviewed at
Source null
created at
2026-09-10T00:00:00Z
provenance class
regulator-cited
discovery note
Found because this study's registry identifier is printed in an FDA approval notice, an FDA product label or an NCI summary held by this site. The citing document and the exact position of the identifier inside it are recorded. Being cited is not a statement that the study supports this treatment.
outcome Count
2
harms Count
1
qol Count
0
outcomes
  1. release id
    clinical-indications-draft-1
    disease state id
    ds-malignant-prostate-neoplasm
    nct id
    NCT02234115
    outcome key
    om-0000
    source section id
    NCT02234115-om-0000
    source outcome index
    0
    endpoint
    Efficacy of Leuprolide Mesylate (LMIS 50mg)
    endpoint definition
    The percentage of subjects with a serum testosterone concentration suppressed to castrate levels (≤ 50 ng/dL) following the first injection of LMIS 50 mg from Day 28 through Day 336 (remaining duration of the study).
    time origin
    baseline to 28 days, 28 days to 336 days
    analysis role
    primary
    reporting status
    POSTED
    data cutoff
    Source null
    population note
    ITT
    curation status
    draft
    reviewed by
    Source null
    reviewed at
    Source null
    created at
    2026-09-10T00:00:00Z
  2. release id
    clinical-indications-draft-1
    disease state id
    ds-malignant-prostate-neoplasm
    nct id
    NCT02234115
    outcome key
    om-0001
    source section id
    NCT02234115-om-0001
    source outcome index
    1
    endpoint
    Number of Participants With Adverse Events (AEs)
    endpoint definition
    Safety analysis was based on the safety information from the laboratory evaluations, AEs, and SAEs.
    time origin
    336 days
    analysis role
    secondary
    reporting status
    POSTED
    data cutoff
    Source null
    population note
    Safety population
    curation status
    draft
    reviewed by
    Source null
    reviewed at
    Source null
    created at
    2026-09-10T00:00:00Z
arms
  1. release id
    clinical-indications-draft-1
    disease state id
    ds-malignant-prostate-neoplasm
    nct id
    NCT02234115
    outcome key
    om-0000
    arm key
    OG000
    arm label
    Leuprolide Mesylate 50mg
    regimen
    All subjects were males with advanced prostate carcinoma. They were injected twice with a depot formulation containing 50 mg of Leuprolide Mesylate. The first dose on day 0 the second dose on day 168 (six months apart). Subjects were followed until day 336. Leuprolide Mesylate: Subcutaneous injection of 50mg Leuprolide Mesylate
    analyzed count
    137
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT02234115-om-0000#groups/OG000
  2. release id
    clinical-indications-draft-1
    disease state id
    ds-malignant-prostate-neoplasm
    nct id
    NCT02234115
    outcome key
    om-0001
    arm key
    OG000
    arm label
    Leuprolide Mesylate 50mg
    regimen
    All subjects were males with advanced prostate carcinoma. They were injected twice with a depot formulation containing 50 mg of Leuprolide Mesylate. The first dose on day 0 the second dose on day 168 (six months apart). Subjects were followed until day 336. Leuprolide Mesylate: Subcutaneous injection of 50mg Leuprolide Mesylate
    analyzed count
    137
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT02234115-om-0001#groups/OG000
harms
  1. release id
    clinical-indications-draft-1
    disease state id
    ds-malignant-prostate-neoplasm
    nct id
    NCT02234115
    harm key
    EG000
    source section id
    NCT02234115-ae
    event group key
    EG000
    event group label
    Leuprolide Mesylate 50mg
    serious affected
    20
    serious at risk
    137
    other affected
    114
    other at risk
    137
    frequency threshold
    5
    collection period
    336 days
    event definition
    Source null
    undenominated note
    Source null
    curation status
    draft
    reviewed by
    Source null
    reviewed at
    Source null
    created at
    2026-09-10T00:00:00Z
quality of life
    setting source links

      Preserved source evidence · Not medical advice