Trial Outcomes & Findings for Special Drug Use Surveillance of Leuplin PRO for Injection Kit 22.5 mg for "Prostate Cancer" (NCT NCT03209492)
NCT ID: NCT03209492
Last Updated: 2019-04-11
Results Overview
Recruitment status
COMPLETED
Target enrollment
333 participants
Primary outcome timeframe
Up to Week 24
Results posted on
2019-04-11
Participant Flow
Participants took part in the study at 61 investigative sites in Japan, from 01 April 2016 to 01 December 2017.
Participants with a historical diagnosis of prostate cancer were enrolled. Participants received interventions as part of routine medical care.
Participant milestones
| Measure |
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.
|
|---|---|
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Overall Study
STARTED
|
333
|
|
Overall Study
COMPLETED
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328
|
|
Overall Study
NOT COMPLETED
|
5
|
Reasons for withdrawal
| Measure |
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.
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|---|---|
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Overall Study
Case Report Forms Uncollected
|
5
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Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
Leuprorelin Acetate 22.5 mg
n=328 Participants
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.
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|---|---|
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Age, Continuous
|
79.1 Years
STANDARD_DEVIATION 6.92 • n=328 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=328 Participants
|
|
Sex: Female, Male
Male
|
328 Participants
n=328 Participants
|
|
Region of Enrollment
Japan
|
328 Participants
n=328 Participants
|
|
Duration between Diagnosis of Prostate Cancer and Study Start
|
53.15 Months
STANDARD_DEVIATION 49.296 • n=323 Participants • The number analyzed is the number of participants with data available for analysis.
|
|
Body Mass Index (BMI)
|
23.49 Kilogram per square meter (kg/m^2)
STANDARD_DEVIATION 3.222 • n=250 Participants • The number analyzed is the number of participants with data available for analysis.
|
|
Prior Treatment of LH-RH Agonists or Antagonist
Not Treated with LH-RH Agonists or Antagonist
|
31 Participants
n=328 Participants
|
|
Prior Treatment of LH-RH Agonists or Antagonist
Treated with LH-RH Agonists or Antagonist
|
297 Participants
n=328 Participants
|
|
Prior Treatment of Drugs for Prostate Cancer
Not Treated with Drugs
|
150 Participants
n=328 Participants
|
|
Prior Treatment of Drugs for Prostate Cancer
Treated with Drugs
|
178 Participants
n=328 Participants
|
|
Eastern Cooperative Oncology Group (ECOG) Performance Status
0
|
243 Participants
n=328 Participants
|
|
Eastern Cooperative Oncology Group (ECOG) Performance Status
1
|
70 Participants
n=328 Participants
|
|
Eastern Cooperative Oncology Group (ECOG) Performance Status
2
|
6 Participants
n=328 Participants
|
|
Eastern Cooperative Oncology Group (ECOG) Performance Status
3
|
6 Participants
n=328 Participants
|
|
Eastern Cooperative Oncology Group (ECOG) Performance Status
4
|
3 Participants
n=328 Participants
|
|
Number of Participants who Had Treated with Adjuvant Therapy
|
36 Participants
n=328 Participants
|
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Number of Participants with Localized Prostate Cancer
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190 Participants
n=328 Participants
|
|
Number of Participants with Locally Advanced Prostate Cancer
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45 Participants
n=328 Participants
|
|
Number of Participants with Metastatic Prostate Cancer
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57 Participants
n=328 Participants
|
|
Number of Participants with Outpatient Care
|
328 Participants
n=328 Participants
|
|
Predisposition to Hypersensitivity
Had No Predisposition to Hypersensitivity
|
321 Participants
n=328 Participants
|
|
Predisposition to Hypersensitivity
Had Predisposition to Hypersensitivity
|
5 Participants
n=328 Participants
|
|
Predisposition to Hypersensitivity
Unknown
|
2 Participants
n=328 Participants
|
|
Medical Complications
Had No Presence of Medical Complications
|
109 Participants
n=328 Participants
|
|
Medical Complications
Had Presence of Medical Complications
|
219 Participants
n=328 Participants
|
|
Medical History of Thromboembolism
Had No History of Thromboembolism
|
293 Participants
n=328 Participants
|
|
Medical History of Thromboembolism
Had History of Thromboembolism
|
33 Participants
n=328 Participants
|
|
Medical History of Thromboembolism
Unknown
|
2 Participants
n=328 Participants
|
PRIMARY outcome
Timeframe: Up to Week 24Population: Safety Analysis Set, The safety analysis set was defined as all participants who completed the study.
Outcome measures
| Measure |
Leuprorelin Acetate 22.5 mg
n=328 Participants
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.
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|---|---|
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Percentage of Participants Who Had One or More Adverse Events
|
4.27 Percentage of Participants
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SECONDARY outcome
Timeframe: Up to Week 24Population: Safety Analysis Set, The safety analysis set was defined as all participants who completed the study.
Adverse drug reaction refers to adverse events related to the administered drug.
Outcome measures
| Measure |
Leuprorelin Acetate 22.5 mg
n=328 Participants
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.
|
|---|---|
|
Percentage of Participants Who Had One or More Adverse Reactions
|
2.74 Percentage of Participants
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Adverse Events
Leuprorelin Acetate 22.5 mg
Serious events: 4 serious events
Other events: 6 other events
Deaths: 4 deaths
Serious adverse events
| Measure |
Leuprorelin Acetate 22.5 mg
n=328 participants at risk
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.
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|---|---|
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Infections and infestations
Pneumonia
|
0.30%
1/328 • 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.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Colon cancer
|
0.30%
1/328 • 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.
|
|
Metabolism and nutrition disorders
Decreased appetite
|
0.30%
1/328 • 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.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
0.30%
1/328 • 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.
|
|
General disorders
Malaise
|
0.30%
1/328 • 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.
|
Other adverse events
| Measure |
Leuprorelin Acetate 22.5 mg
n=328 participants at risk
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.
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|---|---|
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Vascular disorders
Hot flush
|
0.91%
3/328 • 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.
|
|
General disorders
Injection site induration
|
0.91%
3/328 • 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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Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee 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.
- Publication restrictions are in place
Restriction type: OTHER