Prostate Cancer
Conditions
Brief summary
The purpose of this study is to evaluate the safety in patients with prostate cancer receiving the drug in the routine clinical setting.
Detailed 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.
Interventions
DRUGLeuprorelin acetate
Leuplin PRO for Injection Kit 22.5 mg
Sponsors
Takeda
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
MALE
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Percentage of Participants Who Had One or More Adverse Events | Up to Week 24 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Participants Who Had One or More Adverse Reactions | Up to Week 24 | Adverse drug reaction refers to adverse events related to the administered drug. |
Countries
Japan
Participant flow
Recruitment details
Participants took part in the study at 61 investigative sites in Japan, from 01 April 2016 to 01 December 2017.
Pre-assignment details
Participants with a historical diagnosis of prostate cancer were enrolled. Participants received interventions as part of routine medical care.
Participants by arm
| Arm | Count |
|---|---|
| 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. | 328 |
| Total | 328 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Case Report Forms Uncollected | 5 |
Baseline characteristics
| Characteristic | Leuprorelin Acetate 22.5 mg | — |
|---|---|---|
| Age, Continuous | 79.1 Years STANDARD_DEVIATION 6.92 | — |
| Body Mass Index (BMI) | 23.49 Kilogram per square meter (kg/m^2) STANDARD_DEVIATION 3.222 | — |
| Duration between Diagnosis of Prostate Cancer and Study Start | 53.15 Months STANDARD_DEVIATION 49.296 | — |
| Eastern Cooperative Oncology Group (ECOG) Performance Status 0 | 243 Participants | — |
| Eastern Cooperative Oncology Group (ECOG) Performance Status 1 | 70 Participants | — |
| Eastern Cooperative Oncology Group (ECOG) Performance Status 2 | 6 Participants | — |
| Eastern Cooperative Oncology Group (ECOG) Performance Status 3 | 6 Participants | — |
| Eastern Cooperative Oncology Group (ECOG) Performance Status 4 | 3 Participants | — |
| Medical Complications Had No Presence of Medical Complications | 109 Participants | — |
| Medical Complications Had Presence of Medical Complications | 219 Participants | — |
| Medical History of Thromboembolism Had History of Thromboembolism | 33 Participants | — |
| Medical History of Thromboembolism Had No History of Thromboembolism | 293 Participants | — |
| Medical History of Thromboembolism Unknown | 2 Participants | — |
| Number of Participants who Had Treated with Adjuvant Therapy | 36 Participants | — |
| Number of Participants with Localized Prostate Cancer | 190 Participants | — |
| Number of Participants with Locally Advanced Prostate Cancer | 45 Participants | — |
| Number of Participants with Metastatic Prostate Cancer | 57 Participants | — |
| Number of Participants with Outpatient Care | 328 Participants | — |
| Predisposition to Hypersensitivity Had No Predisposition to Hypersensitivity | 321 Participants | — |
| Predisposition to Hypersensitivity Had Predisposition to Hypersensitivity | 5 Participants | — |
| Predisposition to Hypersensitivity Unknown | 2 Participants | — |
| Prior Treatment of Drugs for Prostate Cancer Not Treated with Drugs | 150 Participants | — |
| Prior Treatment of Drugs for Prostate Cancer Treated with Drugs | 178 Participants | — |
| Prior Treatment of LH-RH Agonists or Antagonist Not Treated with LH-RH Agonists or Antagonist | 31 Participants | — |
| Prior Treatment of LH-RH Agonists or Antagonist Treated with LH-RH Agonists or Antagonist | 297 Participants | — |
| Race and Ethnicity Not Collected | — | — Participants |
| Region of Enrollment Japan | 328 Participants | — |
| Sex: Female, Male Female | 0 Participants | — |
| Sex: Female, Male Male | 328 Participants | — |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 4 / 328 |
| other Total, other adverse events | 6 / 328 |
| serious Total, serious adverse events | 4 / 328 |
Outcome results
Primary
Percentage of Participants Who Had One or More Adverse Events
Time frame: Up to Week 24
Population: Safety Analysis Set, The safety analysis set was defined as all participants who completed the study.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Leuprorelin Acetate 22.5 mg | Percentage of Participants Who Had One or More Adverse Events | 4.27 Percentage of Participants |
Secondary
Percentage of Participants Who Had One or More Adverse Reactions
Adverse drug reaction refers to adverse events related to the administered drug.
Time frame: Up to Week 24
Population: Safety Analysis Set, The safety analysis set was defined as all participants who completed the study.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Leuprorelin Acetate 22.5 mg | Percentage of Participants Who Had One or More Adverse Reactions | 2.74 Percentage of Participants |