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| ID | Type | Description | Link |
|---|---|---|---|
| JapicCTI-163213 | Registry Identifier | JapicCTI |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Leuprorelin acetate | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Leuprorelin acetate | Drug | Leuplin PRO for Injection Kit 22.5 mg |
|
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants Who Had One or More Adverse Events | Up to Week 24 |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants Who Had One or More Adverse Reactions | Adverse drug reaction refers to adverse events related to the administered drug. | Up to Week 24 |
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Inclusion Criteria:
Exclusion Criteria:
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The study population will consist of participants with a diagnosis of prostate cancer and received dose of Leuplin PRO for Injection Kit 22.5 mg/Leuprorelin acetate in the routine medical care.
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| Name | Affiliation | Role |
|---|---|---|
| Study Director | Takeda | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Takeda Selected Site | Tokyo | Japan |
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.
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Participants with a historical diagnosis of prostate cancer were enrolled. Participants received interventions as part of routine medical care.
Participants took part in the study at 61 investigative sites in Japan, from 01 April 2016 to 01 December 2017.
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| ID | Title | Description |
|---|---|---|
| FG000 | Leuprorelin Acetate 22.5 mg | 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
Safety Analysis Set, The safety analysis set was defined as all participants who completed the study.
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| ID | Title | Description |
|---|---|---|
| BG000 | Leuprorelin Acetate 22.5 mg | 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. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Percentage of Participants Who Had One or More Adverse Events | Safety Analysis Set, The safety analysis set was defined as all participants who completed the study. | Posted | Number | Percentage of Participants | Up to Week 24 |
|
|
Up to Week 24
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.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Leuprorelin Acetate 22.5 mg | 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. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Pneumonia | Infections and infestations | MedDRA Ver. 20.1 | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Hot flush | Vascular disorders | MedDRA Ver. 20.1 | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Medical Director | Takeda | +1-877-825-3327 | trialdisclosures@takeda.com |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Apr 9, 2018 | Apr 8, 2019 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Jan 30, 2018 | Apr 8, 2019 | SAP_001.pdf |
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| ID | Term |
|---|---|
| D011471 | Prostatic Neoplasms |
| ID | Term |
|---|---|
| D005834 | Genital Neoplasms, Male |
| D014565 | Urogenital Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
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| ID | Term |
|---|---|
| D016729 | Leuprolide |
| ID | Term |
|---|---|
| D007987 | Gonadotropin-Releasing Hormone |
| D010906 | Pituitary Hormone-Releasing Hormones |
| D007028 | Hypothalamic Hormones |
| D036361 | Peptide Hormones |
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| Years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
|
| Region of Enrollment | Number | Participants |
|
| Duration between Diagnosis of Prostate Cancer and Study Start | 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. | Mean | Standard Deviation | Months |
|
| Eastern Cooperative Oncology Group (ECOG) Performance Status | 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. | Count of Participants | Participants |
|
| Number of Participants who Had Treated with Adjuvant Therapy | Count of Participants | Participants |
|
| Number of Participants with Localized Prostate Cancer | Count of Participants | Participants |
|
| Number of Participants with Locally Advanced Prostate Cancer | Count of Participants | Participants |
|
| Number of Participants with Metastatic Prostate Cancer | Count of Participants | Participants |
|
| Number of Participants with Outpatient Care | Count of Participants | Participants |
|
| Predisposition to Hypersensitivity | The baseline characteristic was analyzed in participants who had a liability or tendency to suffer from hypersensitivity. | Count of Participants | Participants |
|
| Medical Complications | 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. | Count of Participants | Participants |
|
| Medical History of Thromboembolism | Number of participants with or without medical history of thromboembolism was reported. | Count of Participants | Participants |
|
| Body Mass Index (BMI) | Body Mass Index = weight (kg)/[height (m)^2] | The number analyzed is the number of participants with data available for analysis. | Mean | Standard Deviation | Kilogram per square meter (kg/m^2) |
|
| Prior Treatment of LH-RH Agonists or Antagonist | Number of participants who had or had not treated with LH-RH agonists or antagonist for prostate cancer was reported. | Count of Participants | Participants |
|
| Prior Treatment of Drugs for Prostate Cancer | Number of participants who had or had not treated with drugs except LH-RH agonists or antagonist for prostate cancer was reported. | Count of Participants | Participants |
|
|
| Secondary | Percentage of Participants Who Had One or More Adverse Reactions | Adverse drug reaction refers to adverse events related to the administered drug. | Safety Analysis Set, The safety analysis set was defined as all participants who completed the study. | Posted | Number | Percentage of Participants | Up to Week 24 |
|
|
|
| 4 |
| 328 |
| 4 |
| 328 |
| 6 |
| 328 |
| Colon cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA Ver. 20.1 | Systematic Assessment |
|
| Decreased appetite | Metabolism and nutrition disorders | MedDRA Ver. 20.1 | Systematic Assessment |
|
| Pulmonary embolism | Respiratory, thoracic and mediastinal disorders | MedDRA Ver. 20.1 | Systematic Assessment |
|
| Malaise | General disorders | MedDRA Ver. 20.1 | Systematic Assessment |
|
| Injection site induration | General disorders | MedDRA Ver. 20.1 | Systematic Assessment |
|
The first study related publication will be a multi-center publication submitted within 24 months after conclusion or termination of a study at all sites. After such multi site publication, all proposed site publications and presentations will be submitted to sponsor for review 60 days in advance of publication. Site will remove Sponsor confidential information unrelated to study results. Sponsor can delay a proposed publication for another 60 days to preserve intellectual property.
| D005832 |
| Genital Diseases, Male |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D011469 | Prostatic Diseases |
| D052801 | Male Urogenital Diseases |
| D006728 | Hormones |
| D006730 | Hormones, Hormone Substitutes, and Hormone Antagonists |
| D009479 | Neuropeptides |
| D010455 | Peptides |
| D000602 | Amino Acids, Peptides, and Proteins |
| D009842 | Oligopeptides |
| D009419 | Nerve Tissue Proteins |
| D011506 | Proteins |