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

Takeda

Status: Completed

Conditions: Prostate Cancer

Treatments: Drug: Leuprorelin acetate

Study type: Observational

Funder types: Industry

Identifiers

NCT02167893

JapicCTI-142560 (Registry Identifier)

265-021

JapicCTI-R160837 (Other Identifier)

Details and patient eligibility

About

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.

Full 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 participants 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.

Enrollment: 11,288 patients

Sex: Male

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Inclusion Criteria: Prostate cancer participants who meet all the following criteria:

1. Participants for whom prostate cancer was initially diagnosed on or after January 1, 2005
2. 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 )
3. 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:

Trial design

11,288 participants in 1 patient group

Subcutaneous administration of leuprorelin acetate

Description:

Subcutaneous administration of leuprorelin acetate once every 12 weeks as daily medicinal practice.

Treatment:

Drug: Leuprorelin acetate