NIPH Clinical Trials Search

Basic Information

Recruitment status
Health condition(s) or Problem(s) studied	Prostate cancer
Date of first enrollment	02/06/2014
Target sample size	10000
Countries of recruitment
Study type	Observational
Intervention(s)	investigational material(s) Generic name etc : Leuplin SR 11.25 mg Injection Kit (leuprorelin acetate) INN of investigational material : Therapeutic category code : 249 Other hormone preparations (including antihormone preparations) Dosage and Administration for Investigational material : For adults, 11.25 mg of leuprorelin acetate is usually administered subcutaneously once every 12 weeks. Prior to injection, the plunger rod of the syringe is pushed upward with the needle pointed upward, allowing the entire suspension fluid contained to be transferred to the powder. The powder is then fully suspended in the fluid while ensuring that bubbles are not generated.

Outcome(s)

Primary Outcome

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 Outcome

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.

Key inclusion & exclusion criteria

Age minimum	Not applicable
Age maximum	Not applicable
Gender	Both
Include 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
Exclude criteria