N/A
N=11,288
Leuplin SR 11.25 mg Injection Kit Specified Drug-use Survey "Long-term Use Survey in Prostate Cancer Patients (96 Weeks)"
Prostate Cancer
Bottom Line
View on ClinicalTrials.gov: NCT02167893 ↗Enrolled (actual)
11,288
Serious AEs
1.7%
Results posted
Mar 2017
Primary outcome: Primary: Number of Participants Reporting One or More Adverse Drug Reactions — 2052 participants
Study Design & Population
- Study type
- Observational
- Phase
- N/A
- Interventions
- Leuprorelin acetate (Drug)
- Age
- Pediatric, Adult, Older Adult
- Sex
- Male
- Sponsor
- Takeda
- Primary completion
- Dec 2010
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants Reporting One or More Adverse Drug Reactions |
2052 | — |
| PRIMARY Number of Participants Reporting One or More Serious Adverse Drug Reactions |
188 | — |
| SECONDARY Percentage of Participants With Progression Free Survival (PFS) Based on TNM Classification |
94.2; 92.0; 86.9; 55.4 | — |
| SECONDARY Percentage of Participants With Overall Survival (OS) Based on TNM Classification |
96.9; 97.4; 97.6; 88.5 | — |
| SECONDARY Percentage of Participants With Metastasis-free Survival |
— | — |
| SECONDARY Percentage of Participants With Disease-specific Survival |
— | — |
Summary
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.
Eligibility Criteria
Inclusion Criteria: Prostate cancer participants who meet all the following criteria:
- Participants for whom prostate cancer was initially diagnosed on or after January 1, 2005
- 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 )
- 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
-
Data sourced from ClinicalTrials.gov (NCT02167893). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.