Trial · NCT02167893
Leuplin SR 11.25 mg Injection Kit Specified Drug-use Survey "Long-term Use Survey in Prostate Cancer Patients (96 Weeks)"
NCT02167893, Completed, Takeda; results first posted 2017-03-29
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Leuplin SR 11.25 mg Injection Kit Specified Drug-use Survey "Long-term Use Survey in Prostate Cancer Patients (96 Weeks)". Trials, record NCT02167893. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02167893
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Leuplin SR 11.25 mg Injection Kit Specified Drug-use Survey "Long-term Use Survey in Prostate Cancer Patients (96 Weeks)"
- NCT number
- NCT02167893
- Status
- Completed
- Enrollment
- 11,288 participants, actual
- Lead sponsor
- Takeda
- Conditions
- Prostate Cancer
- Interventions
- Leuprorelin acetate
- First posted
- 2014-06-19
- Last updated
- 2017-03-29
- Results first posted
- 2017-03-29
Source ClinicalTrials.gov
Registered outcomes6
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Number of Participants Reporting One or More Adverse Drug Reactions | Baseline up to Week 96 | 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. |
| Primary | Number of Participants Reporting One or More Serious Adverse Drug Reactions | Baseline up to Week 96 | 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 | Percentage of Participants With Progression Free Survival (PFS) Based on TNM Classification | Baseline up to 96 weeks | 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. |
| Secondary | Percentage of Participants With Overall Survival (OS) Based on TNM Classification | Baseline up to 96 weeks or death (which ever occurs first) | 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. |
| Secondary | Percentage of Participants With Metastasis-free Survival | Baseline up to 96 weeks | |
| Secondary | Percentage of Participants With Disease-specific Survival | Baseline up to 96 weeks | 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. |
Source ClinicalTrials.gov
Outcomes6
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Number of Participants Reporting One or More Adverse Drug Reactions | Baseline up to Week 96 | The safety analysis set was defined as all participants who were enrolled and completed the study. | participants | NUMBER |
| PRIMARY | Number of Participants Reporting One or More Serious Adverse Drug Reactions | Baseline up to Week 96 | The safety analysis set was defined as all participants who were enrolled and completed the study. | participants | NUMBER |
| SECONDARY | Percentage of Participants With Progression Free Survival (PFS) Based on TNM Classification | Baseline up to 96 weeks | The efficacy assessment population was defined as all participants whose efficacy data at baseline and at least 1 post-baseline time points was available. | percentage of participants | NUMBER |
| SECONDARY | Percentage of Participants With Overall Survival (OS) Based on TNM Classification | Baseline up to 96 weeks or death (which ever occurs first) | The efficacy assessment population was defined as all participants whose efficacy data at baseline and at least 1 post-baseline time points was available. | percentage of participants | NUMBER |
| SECONDARY | Percentage of Participants With Metastasis-free Survival | Baseline up to 96 weeks | No results have been reported in this measure because as predefined in the protocol, the outcome measure was not planned to be assessed. | ||
| SECONDARY | Percentage of Participants With Disease-specific Survival | Baseline up to 96 weeks | No results have been reported in this measure because as predefined in the protocol, the outcome measure was not planned to be assessed. |
Source ClinicalTrials.gov
Results by group10
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Number of Participants Reporting One or More Adverse Drug Reactions | Leuprorelin Acetate | 2052 | participants | ||
| Number of Participants Reporting One or More Serious Adverse Drug Reactions | Leuprorelin Acetate | 188 | participants | ||
| Percentage of Participants With Progression Free Survival (PFS) Based on TNM Classification | Leuprorelin Acetate | Stage I (N=467) | 94.2 | 95% Confidence Interval 91.4 to 96.2 | percentage of participants |
| Percentage of Participants With Progression Free Survival (PFS) Based on TNM Classification | Leuprorelin Acetate | Stage II (N=4852) | 92.0 | 95% Confidence Interval 91.2 to 92.8 | percentage of participants |
| Percentage of Participants With Progression Free Survival (PFS) Based on TNM Classification | Leuprorelin Acetate | Stage III (N=1926) | 86.9 | 95% Confidence Interval 85.2 to 88.4 | percentage of participants |
| Percentage of Participants With Progression Free Survival (PFS) Based on TNM Classification | Leuprorelin Acetate | Stage IV (N=2446) | 55.4 | 95% Confidence Interval 53.3 to 57.5 | percentage of participants |
| Percentage of Participants With Overall Survival (OS) Based on TNM Classification | Leuprorelin Acetate | Stage I (N=466) | 96.9 | 95% Confidence Interval 94.6 to 98.2 | percentage of participants |
| Percentage of Participants With Overall Survival (OS) Based on TNM Classification | Leuprorelin Acetate | Stage II (N=4852) | 97.4 | 95% Confidence Interval 96.8 to 97.8 | percentage of participants |
| Percentage of Participants With Overall Survival (OS) Based on TNM Classification | Leuprorelin Acetate | Stage III (N=1927) | 97.6 | 95% Confidence Interval 96.7 to 98.2 | percentage of participants |
| Percentage of Participants With Overall Survival (OS) Based on TNM Classification | Leuprorelin Acetate | Stage IV (N=2443) | 88.5 | 95% Confidence Interval 87.0 to 89.8 | percentage of participants |
Source ClinicalTrials.gov
Participant flow3
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Leuprorelin Acetate | 11,288 | |
| Overall Study | COMPLETED | Leuprorelin Acetate | 11,125 | |
| Overall Study | NOT COMPLETED | Leuprorelin Acetate | 163 |
Source ClinicalTrials.gov
Adverse events163
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Injection site erythema | General disorders | Leuprorelin Acetate | 278 | 11,125 | |
| other | Injection site induration | General disorders | Leuprorelin Acetate | 904 | 11,125 | |
| other | Hot flush | Vascular disorders | Leuprorelin Acetate | 247 | 11,125 | |
| serious | Gastroenteritis | Infections and infestations | Leuprorelin Acetate | 2 | 11,125 | |
| serious | Herpes zoster | Infections and infestations | Leuprorelin Acetate | 1 | 11,125 | |
| serious | Injection site abscess | Infections and infestations | Leuprorelin Acetate | 6 | 11,125 | |
| serious | Lung abscess | Infections and infestations | Leuprorelin Acetate | 1 | 11,125 | |
| serious | Pneumonia | Infections and infestations | Leuprorelin Acetate | 10 | 11,125 | |
| serious | Pyelonephritis | Infections and infestations | Leuprorelin Acetate | 1 | 11,125 | |
| serious | Urinary tract infection | Infections and infestations | Leuprorelin Acetate | 1 | 11,125 |
1 to 10 of 163Source ClinicalTrials.gov
See all 163 adverse eventsAdverse event totals3
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Leuprorelin Acetate | ||
| Total, other adverse events | Leuprorelin Acetate | 1,429 | 11,125 |
| Total, serious adverse events | Leuprorelin Acetate | 188 | 11,125 |
Source ClinicalTrials.gov
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT02167893
GET https://conductscience.org/api/trials/v1/NCT02167893/events?page=2