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

Prostate Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02167893
• Other study ID #: 265-021
• Status: Completed
• Phase: N/A
• First received: June 17, 2014
• Last updated: June 17, 2014
• Start date: October 2005
• Est. completion date: August 2008

Study information

• Verified date: June 2014
• Source: Takeda
• Contact: n/a
• Is FDA regulated: No
• Health authority: Japan: Ministry of Health, Labor and Welfare
• Study type: Observational

Clinical Trial 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 mg injection kit (Leuplin SR 11.25 mg Injection Kit) in prostate cancer patients in daily medical practice.

Description:

This survey was designed to evaluate the efficacy and safety of long-term use (96 weeks) of leuprorelin acetate 3 months depot injection kit (Leuplin SR 11.25 mg Injection Kit) in prostate cancer patients in daily medical practice.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 11288
• Est. completion date: August 2008
• Est. primary completion date: August 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A and older

Eligibility

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:

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Prostate Cancer
• Prostatic Neoplasms

Intervention

Drug:
• Leuprorelin acetate
Leuprorelin acetate SR 11.25 mg injection kit

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Takeda

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Frequency of adverse drug reactions	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.	For 96 weeks	Yes
Secondary	Progression-free survival	Progression-free survival from baseline until 96 weeks of treatment with Leuplin SR 11.25 mg Injection Kit are estimated using the Kaplan-Meier method.	From baseline to 96 weeks of treatment	No
Secondary	Metastasis-free survival	Metastasis-free survival from baseline until 96 weeks of treatment with Leuplin SR 11.25 mg Injection Kit are estimated using the Kaplan-Meier method.	From baseline to 96 weeks of treatment	No
Secondary	Disease-specific survival	Disease-specific survival from baseline until 96 weeks of treatment with Leuplin SR 11.25 mg Injection Kit are estimated using the Kaplan-Meier method.	From baseline to 96 weeks of treatment	No
Secondary	Overall survival	Overall survival from baseline until 96 weeks of treatment with Leuplin SR 11.25 mg Injection Kit are estimated using the Kaplan-Meier method.	From baseline to 96 weeks of treatment	No