Special Drug Use Surveillance of Leuplin PRO for Injection Kit 22.5 mg for "Prostate Cancer"

Takeda

Status: Completed

Conditions: Prostate Cancer

Treatments: Drug: Leuprorelin acetate

Study type: Observational

Funder types: Industry

Identifiers

NCT03209492

Leuprorelin-5002

JapicCTI-163213 (Registry Identifier)

Details and patient eligibility

About

The purpose of this study is to evaluate the safety in patients with prostate cancer receiving the drug in the routine clinical setting.

Full description

The drug being tested in this study is called Leuprorelin acetate (Leuplin PRO for Injection Kit 22.5 mg). Leuprorelin acetate is being tested to treat people who have prostate cancer.

This study will look at the safety in patients with prostate cancer receiving the drug in the routine clinical setting.

The study will enroll approximately 300 patients.

• Leuprorelin acetate

This multi-center trial will be conducted in Japan.

Enrollment: 333 patients

Sex: Male

Volunteers: No Healthy Volunteers

Inclusion criteria

• Participants with prostate cancer will be included.

Exclusion criteria

• Participants with previous history of hypersensitivity to any of the ingredients of the drug or synthetic LH-RH or LH-RH derivatives

Trial design

333 participants in 1 patient group

Leuprorelin acetate

Description:

Usually, for adults, 22.5 mg of leuprorelin acetate is subcutaneously administered once every 24 weeks. Refer to the Precautions section of the package insert. Participants will receive interventions as part of routine medical care.

Treatment:

Drug: Leuprorelin acetate