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

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ClinicalTrials.gov Identifier: NCT03209492
Recruitment Status : Completed
First Posted : July 6, 2017
Results First Posted : April 11, 2019
Last Update Posted : April 11, 2019
Sponsor:
Information provided by (Responsible Party):
Takeda

Study Type Observational
Study Design Observational Model: Cohort;   Time Perspective: Prospective
Condition Prostate Cancer
Intervention Drug: Leuprorelin acetate
Enrollment 333
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.
Arm/Group Title Leuprorelin Acetate 22.5 mg
Hide Arm/Group Description 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.
Period Title: Overall Study
Started 333
Completed 328
Not Completed 5
Reason Not Completed
Case Report Forms Uncollected             5
Arm/Group Title Leuprorelin Acetate 22.5 mg
Hide Arm/Group Description 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.
Overall Number of Baseline Participants 328
Hide Baseline Analysis Population Description
Safety Analysis Set, The safety analysis set was defined as all participants who completed the study.
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 328 participants
79.1  (6.92)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 328 participants
Female
0
   0.0%
Male
328
 100.0%
Race and Ethnicity Not Collected   [1] 
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 0 participants
[1]
Measure Analysis Population Description: Race and Ethnicity were not collected from any participant.
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
Japan Number Analyzed 328 participants
328
Duration between Diagnosis of Prostate Cancer and Study Start   [1] [2] 
Mean (Standard Deviation)
Unit of measure:  Months
Number Analyzed 323 participants
53.15  (49.296)
[1]
Measure Description: Mean duration between the first diagnosis of prostate cancer and the start of the study was reported.
[2]
Measure Analysis Population Description: The number analyzed is the number of participants with data available for analysis.
Eastern Cooperative Oncology Group (ECOG) Performance Status   [1] 
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 328 participants
0
243
  74.1%
1
70
  21.3%
2
6
   1.8%
3
6
   1.8%
4
3
   0.9%
[1]
Measure Description: 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.
Number of Participants who Had Treated with Adjuvant Therapy  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 328 participants
36
  11.0%
Number of Participants with Localized Prostate Cancer  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 328 participants
190
  57.9%
Number of Participants with Locally Advanced Prostate Cancer  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 328 participants
45
  13.7%
Number of Participants with Metastatic Prostate Cancer  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 328 participants
57
  17.4%
Number of Participants with Outpatient Care  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 328 participants
328
 100.0%
Predisposition to Hypersensitivity   [1] 
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 328 participants
Had No Predisposition to Hypersensitivity
321
  97.9%
Had Predisposition to Hypersensitivity
5
   1.5%
Unknown
2
   0.6%
[1]
Measure Description: The baseline characteristic was analyzed in participants who had a liability or tendency to suffer from hypersensitivity.
Medical Complications   [1] 
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 328 participants
Had No Presence of Medical Complications
109
  33.2%
Had Presence of Medical Complications
219
  66.8%
[1]
Measure Description: 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 History of Thromboembolism   [1] 
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 328 participants
Had No History of Thromboembolism
293
  89.3%
Had History of Thromboembolism
33
  10.1%
Unknown
2
   0.6%
[1]
Measure Description: Number of participants with or without medical history of thromboembolism was reported.
Body Mass Index (BMI)   [1] [2] 
Mean (Standard Deviation)
Unit of measure:  Kilogram per square meter (kg/m^2)
Number Analyzed 250 participants
23.49  (3.222)
[1]
Measure Description: Body Mass Index = weight (kg)/[height (m)^2]
[2]
Measure Analysis Population Description: The number analyzed is the number of participants with data available for analysis.
Prior Treatment of LH-RH Agonists or Antagonist   [1] 
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 328 participants
Not Treated with LH-RH Agonists or Antagonist
31
   9.5%
Treated with LH-RH Agonists or Antagonist
297
  90.5%
[1]
Measure Description: Number of participants who had or had not treated with LH-RH agonists or antagonist for prostate cancer was reported.
Prior Treatment of Drugs for Prostate Cancer   [1] 
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 328 participants
Not Treated with Drugs
150
  45.7%
Treated with Drugs
178
  54.3%
[1]
Measure Description: Number of participants who had or had not treated with drugs except LH-RH agonists or antagonist for prostate cancer was reported.
1.Primary Outcome
Title Percentage of Participants Who Had One or More Adverse Events
Hide Description [Not Specified]
Time Frame Up to Week 24
Hide Outcome Measure Data
Hide Analysis Population Description
Safety Analysis Set, The safety analysis set was defined as all participants who completed the study.
Arm/Group Title Leuprorelin Acetate 22.5 mg
Hide Arm/Group Description:
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.
Overall Number of Participants Analyzed 328
Measure Type: Number
Unit of Measure: Percentage of Participants
4.27
2.Secondary Outcome
Title Percentage of Participants Who Had One or More Adverse Reactions
Hide Description Adverse drug reaction refers to adverse events related to the administered drug.
Time Frame Up to Week 24
Hide Outcome Measure Data
Hide Analysis Population Description
Safety Analysis Set, The safety analysis set was defined as all participants who completed the study.
Arm/Group Title Leuprorelin Acetate 22.5 mg
Hide Arm/Group Description:
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.
Overall Number of Participants Analyzed 328
Measure Type: Number
Unit of Measure: Percentage of Participants
2.74
Time Frame Up to Week 24
Adverse Event Reporting Description 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.
 
Arm/Group Title Leuprorelin Acetate 22.5 mg
Hide Arm/Group Description 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.
All-Cause Mortality
Leuprorelin Acetate 22.5 mg
Affected / at Risk (%)
Total   4/328 (1.22%) 
Show Serious Adverse Events Hide Serious Adverse Events
Leuprorelin Acetate 22.5 mg
Affected / at Risk (%)
Total   4/328 (1.22%) 
General disorders   
Malaise  1  1/328 (0.30%) 
Infections and infestations   
Pneumonia  1  1/328 (0.30%) 
Metabolism and nutrition disorders   
Decreased appetite  1  1/328 (0.30%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)   
Colon cancer  1  1/328 (0.30%) 
Respiratory, thoracic and mediastinal disorders   
Pulmonary embolism  1  1/328 (0.30%) 
1
Term from vocabulary, MedDRA Ver. 20.1
Indicates events were collected by systematic assessment
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0.5%
Leuprorelin Acetate 22.5 mg
Affected / at Risk (%)
Total   6/328 (1.83%) 
General disorders   
Injection site induration  1  3/328 (0.91%) 
Vascular disorders   
Hot flush  1  3/328 (0.91%) 
1
Term from vocabulary, MedDRA Ver. 20.1
Indicates events were collected by systematic assessment
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
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.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Medical Director
Organization: Takeda
Phone: +1-877-825-3327
EMail: trialdisclosures@takeda.com
Layout table for additonal information
Responsible Party: Takeda
ClinicalTrials.gov Identifier: NCT03209492     History of Changes
Other Study ID Numbers: Leuprorelin-5002
JapicCTI-163213 ( Registry Identifier: JapicCTI )
First Submitted: July 4, 2017
First Posted: July 6, 2017
Results First Submitted: November 30, 2018
Results First Posted: April 11, 2019
Last Update Posted: April 11, 2019