Neoplasms

Urinary Tract, Sexual Organs, and Pregnancy Conditions

All Conditions

Prostatic Neoplasms

Genital Neoplasms, Male

Urogenital Neoplasms

Genital Diseases

Genital Diseases, Male

Urogenital Diseases

Prostatic Diseases

Male Urogenital Diseases

Antineoplastic Agents

Reproductive Control Agents

All Drugs and Chemicals

Leuprolide

Antineoplastic Agents, Hormonal

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.

Leuprorelin acetate

Study Director

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

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.

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

Takeda makes patient-level, de-identified data sets and associated documents available for all interventional studies after applicable marketing approvals and commercial availability have been received (or program is completely terminated), an opportunity for the primary publication of the research and final report development has been allowed, and other criteria have been met as set forth in Takeda's Data Sharing Policy (see www.TakedaClinicalTrials.com for details). To obtain access, researchers must submit a legitimate academic research proposal for adjudication by an independent review panel, who will review the scientific merit of the research and the requestor's qualifications and conflict of interest that can result in potential bias. Once approved, qualified researchers who sign a data sharing agreement are provided access to these data in a secure research environment.

Adverse drug reaction refers to adverse events related to the administered drug.

Takeda

At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.

Usually, for adults, 22.5 mg of Leuprorelin Acetate was subcutaneously administered once every 24 weeks. Refer to the Precautions section of the package insert. Participants received interventions as part of routine medical care.

Leuprorelin Acetate 22.5 mg

Age, Continuous

Sex: Female, Male

Race and Ethnicity were not collected from any participant.

Race and Ethnicity Not Collected

Japan

Region of Enrollment

Mean duration between the first diagnosis of prostate cancer and the start of the study was reported.

The number analyzed is the number of participants with data available for analysis.

Duration between Diagnosis of Prostate Cancer and Study Start

Number of participants with each score of ECOG Performance Status at the study start was reported. Following are ECOG grades. 0: Fully active, perform all pre-disease activities without restriction. 1: Restricted in physically strenuous activity but ambulatory, carry out work of a light or sedentary nature. 2: Ambulatory, capable of self-care, unable to carry out any work activities, up and about more than (\>) 50% of waking hours. 3: Capable of limited self-care, confined to bed or chair \>50% of waking hours. 4: Completely disabled, not capable of any self-care, totally confined to bed/chair.

Eastern Cooperative Oncology Group (ECOG) Performance Status

Number of Participants who Had Treated with Adjuvant Therapy

Number of Participants with Localized Prostate Cancer

Number of Participants with Locally Advanced Prostate Cancer

Number of Participants with Metastatic Prostate Cancer

Number of Participants with Outpatient Care

The baseline characteristic was analyzed in participants who had a liability or tendency to suffer from hypersensitivity.

Predisposition to Hypersensitivity

Complications defined as a disease or a health condition for each participant at the start of study. Complications were classified as congenital anomalies, endocrine disorders, hematologic disorders, psychiatric and nervous system disorders, cardiovascular disorders, respiratory disorders, gastrointestinal (GI) disorders, renal disease and other complications. Other complications included all complications except for those mentioned above.

Medical Complications

Number of participants with or without medical history of thromboembolism was reported.

Medical History of Thromboembolism

Body Mass Index = weight (kg)/\[height (m)\^2\]

Body Mass Index (BMI)

Number of participants who had or had not treated with LH-RH agonists or antagonist for prostate cancer was reported.

Prior Treatment of LH-RH Agonists or Antagonist

Number of participants who had or had not treated with drugs except LH-RH agonists or antagonist for prostate cancer was reported.

Prior Treatment of Drugs for Prostate Cancer

Safety Analysis Set, The safety analysis set was defined as all participants who completed the study.

Spots Global Cancer Trial Database for Special Drug Use Surveillance of Leuplin PRO for Injection Kit 22.5 mg for "Prostate Cancer"

Trial Identification

Conditions

Interventions

Study Description

Keywords

Eligibility

Locations

Contact Details

Useful links and downloads for this trial