Prostate cancer
Conditions
Sponsors
TAKEDA PHARMACEUTICAL COMPANY LTD.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Prostate cancer patients who meet all the following criteria: 1. Patients for whom prostate cancer was initially diagnosed on or after January 1, 2005 2. Patients with no prior history of treatment with Leuplin SR 11.25 mg Injection Kit (as an exception, patients with prior history of treatment with Leuplin 3.75 mg Injection Kit may be enrolled in the survey ) 3. Patients 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
Exclusion criteria:
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Frequency of adverse drug reactions Primary timeframe: For 96 weeks Frequency, seriousness, and time to onset of adverse events are tabulated by symptom. Adverse events are defined as all unfavorable and unintended signs, symptoms or diseases temporally associated with the use of the medicinal product reported during the period from the first to the last dose of Leuplin SR 11.25 mg Injection Kit. Among these, events which are considered possibly related to the study drug are defined as adverse drug reactions. | — |
Secondary
| Measure | Time frame |
|---|---|
| Progression-free survival, metastasis-free survival, disease-specific survival, and overall survival Secondary timeframe: From baseline to 96 weeks of treatment Progression-free survival, metastasis-free survival, disease-specific survival, and overall survival from baseline until 96 weeks of treatment with Leuplin SR 11.25 mg Injection Kit are estimated using the Kaplan-Meier method. | — |
Outcome results
None listed