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Trial · Observational

CompletedPhase not statedResults postedRegistry data

Leuplin SR 11.25 mg Injection Kit Specified Drug-use Survey "Long-term Use Survey in Prostate Cancer Patients (96 Weeks)"

NCTNCT02167893 (opens ClinicalTrials.gov in a new tab)Other id265-021Other idJapicCTI-142560Other idJapicCTI-R160837
Open at ClinicalTrials.govAsk about this trial

Overview

Status
Completed
Phase
Phase not stated
Enrollment
11,288 participants (actual)
Sponsor
Takeda · Industry
Design
Not stated
Countries
Not stated
Start
Oct 2005
Primary completion
Dec 2010
Completion
Dec 2010
First posted
19 Jun 2014 (estimated)
Last update posted
29 Mar 2017
Conditions
Prostate Cancer

Timeline

1 trial · 1 completed · 1 with posted results

  • Completed
  • Ongoing
  • Not yet recruiting
  • Stopped
  • Estimated dates (est.)
  • Results posted
2005200620072008200920102011
  1. Ph –

    Leuplin SR 11.25 mg Injection Kit Specified Drug-use Survey "Long-term Use Survey in Prostate Cancer Patients (96 Weeks)"

    NCT02167893

    Oct 2005 to Dec 2010

Registry summary

Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.

The purpose of this survey is designed to evaluate the efficacy and safety of long-term use (96 weeks) of leuprorelin acetate SR 11.25 milligram (mg) injection kit (Leuplin SR 11.25 mg injection kit) in prostate cancer participants in daily medical practice.

Interventions

  • Leuprorelin acetateDrug

Arms1

  • Other

    Subcutaneous administration of leuprorelin acetate

    Subcutaneous administration of leuprorelin acetate once every 12 weeks as daily medicinal practice.

Primary outcomes2

Outcomes the sponsor listed as primary.

  1. Number of Participants Reporting One or More Adverse Drug Reactions

    Time frame · Baseline up to Week 96

    Registry description

    Adverse drug reactions are defined as adverse events (AEs) which are in the investigator's opinion of causal relationship to the study treatment. AEs are defined as any unfavorable and unintended signs, symptoms or diseases temporally associated with the use of a medicinal product reported from the first dose of study drug to the last dose of study drug.

  2. Number of Participants Reporting One or More Serious Adverse Drug Reactions

    Time frame · Baseline up to Week 96

    Registry description

    Serious adverse drug reactions are defined as serious adverse events (SAE) which are in the investigator's opinion of causal relationship to the study treatment. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly.

Secondary outcomes(4)

  1. Percentage of Participants With Progression Free Survival (PFS) Based on TNM Classification

    Time frame · Baseline up to 96 weeks

    Registry description

    PFS was defined as the time from the first day of study treatment to documented disease progression or death on study. For participants who experienced no disease progression and did not die while on study, data were censored at the date of the last tumor assessment. Kaplan-Meier methodology was used to estimate PFS. TNM classification based on tumor size, if cancer cells had spread to nearby lymph nodes (LN), or distant metastasis. Stages included: stage 0(no evidence of cancer cells),stage 1(T1N0M0), stage IIA(T0N1M0, T1N1M0, T2N0M0), stage IIB(T2N1M0, T3N0M0), stage IIIA(T0N2M0, T1N2M0, T2N3M0, T3N1orN2M0),stage IIIb( T4 anyNM0, any TN3M0),stage IIIC(any TN3M0), stage IV(any T any NM1), where T0=early form of tumor, T1=\<2 centimeter (cm), T2=2-5 cm, T3=\>2 cm, T4=large sized, N0=not spread to LN, N1=spread to 1 to 3,N2=spread to 4 to 9,N3=spread \>10 axillary LN, M0=no metastasis, M1= Metastasis.

  2. Percentage of Participants With Overall Survival (OS) Based on TNM Classification

    Time frame · Baseline up to 96 weeks or death (which ever occurs first)

    Registry description

    OS was defined as the duration from randomization to death (due to any cause). Probability of OS was reported using Kaplan-Meier method. TNM classification based on tumor size, if cancer cells had spread to nearby lymph nodes (LN), or distant metastasis. Stages included: stage 0(no evidence of cancer cells),stage 1(T1N0M0), stage IIA(T0N1M0, T1N1M0, T2N0M0), stage IIB(T2N1M0, T3N0M0), stage IIIA(T0N2M0, T1N2M0, T2N3M0, T3N1orN2M0),stage IIIb( T4 anyNM0, any TN3M0),stage IIIC(any TN3M0), stage IV(any T any NM1), where T0=early form of tumor, T1=\<2 centimeter (cm), T2=2-5 cm, T3=\>2 cm, T4=large sized, N0=not spread to LN, N1=spread to 1 to 3,N2=spread to 4 to 9,N3=spread \>10 axillary LN, M0=no metastasis, M1= Metastasis.

  3. Percentage of Participants With Metastasis-free Survival

    Time frame · Baseline up to 96 weeks

  4. Percentage of Participants With Disease-specific Survival

    Time frame · Baseline up to 96 weeks

    Registry description

    Disease-specific survival is defined as time interval between the date of randomization and the earliest date of local, regional or distant relapse, or death due to cancer.

Posted results

Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.

Primary outcome results

Primary outcomeNumber· Baseline up to Week 96

Number of Participants Reporting One or More Adverse Drug Reactions

GroupValue (participants)
Leuprorelin Acetate2052
Primary outcomeNumber· Baseline up to Week 96

Number of Participants Reporting One or More Serious Adverse Drug Reactions

GroupValue (participants)
Leuprorelin Acetate188
Secondary and other outcome results(4)
Secondary outcomeNumber· Baseline up to 96 weeks

Percentage of Participants With Progression Free Survival (PFS) Based on TNM Classification

GroupValue (percentage of participants)
Leuprorelin Acetate94.2
Secondary outcomeNumber· Baseline up to 96 weeks or death (which ever occurs first)

Percentage of Participants With Overall Survival (OS) Based on TNM Classification

GroupValue (percentage of participants)
Leuprorelin Acetate96.9
Secondary outcome· Baseline up to 96 weeks

Percentage of Participants With Metastasis-free Survival

GroupValue
Leuprorelin Acetatenot posted
Secondary outcome· Baseline up to 96 weeks

Percentage of Participants With Disease-specific Survival

GroupValue
Leuprorelin Acetatenot posted

Adverse events, as posted

Adverse events as posted: participants affected out of participants at risk, by group
GroupDeathsSerious eventsOther events
Leuprorelin AcetateParticipants receiving leuprorelin acetate 11.25 mg, injection subcutaneously once every 12 weeks up to 96 weeks as daily medical practice were observed.–188 / 11,1251429 / 11,125

Each cell reads participants affected / participants at risk, as the registry posted them.

Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works

Studies0

Studies that cite this trial.

No study cites this trial.

Eligibility

Who could join, as posted.

Sex
Male
Age
Not stated
Healthy volunteers
Not accepted
Inclusion and exclusion criteria, as posted
Inclusion Criteria: Prostate cancer participants who meet all the following criteria: 1. Participants for whom prostate cancer was initially diagnosed on or after January 1, 2005 2. Participants with no prior history of treatment with Leuplin SR 11.25 mg Injection Kit (as an exception, participants with prior history of treatment with Leuplin 3.75 mg Injection Kit may be enrolled in the survey ) 3. Participants with prostate-specific antigen (PSA) level determined at baseline or within 3 months prior to the start of treatment with Leuplin SR 11.25 mg Injection Kit Exclusion Criteria: \-

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