Prostate Cancer
Conditions
Keywords
Leuprolide acetate, Prostate cancer
Brief summary
The objective of this study was to evaluate the safety profile of ELIGARD® in ethnic Asian prostate cancer patients.
Interventions
DRUGLeuprolide
Subcutaneous Injection
Sponsors
Astellas Pharma Singapore Pte. Ltd.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
MALE
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* A patient for whom the physician has decided to initiate treatment with a Luteinizing Hormone Releasing Hormone (LHRH) agonist in standard clinical practice * Biopsy-proven prostate adenocarcinoma * Locally advanced prostate cancer with biochemical relapse radical prostatectomy and/or radiotherapy, OR hormonal treatment-naive advanced or metastatic prostate cancer patient who has not received chemotherapy and has no plans to undergo treatment with chemotherapy at study entry. * Patient who indicates that once the study is completed, he expects having access to androgen deprivation therapy (ADT), either medical or surgical, within the local healthcare system (either through public/ private health insurance or out of pocket payment).
Exclusion criteria
* Patient with castrate resistant prostate cancer * Patient who previously underwent bilateral orchiectomy * Patient who has received prior treatment with LHRH analogues * Prior or concomitant treatment with systemic chemotherapy. A patient where there is a likelihood to receive systemic chemotherapy should not be enrolled * Life expectancy of \< 1 year due to comorbidities * Participation in another interventional clinical trial within one month prior to study entry or during the duration of the study * Patient who plans to receive intermittent ADT at the time of study entry * Patient receiving non-palliative radiotherapy within 3 months prior to study entry * Patient receiving adjuvant ADT in combination with definitive radiotherapy * Patient with metastatic hormonal treatment-naive prostate cancer, for whom chemo-hormonal treatment (combination of Docetaxel and ADT) is indicated. * Patient with hypersensitivity to gonadotropin releasing hormone (GnRH), GnRH agonist analogs or any of the components of ELIGARD® * Patient with any contraindication for ELIGARD® use based on local prescribing information
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Eligard Related Adverse Events (AE) | From first dose of study drug up to 18 months | An AE was defined as any untoward medical occurrence in a participant administered a study drug or had undergone study procedures that did not necessarily have a causal relationship with this treatment. An AE was considered to be serious if, in the view of either the investigator or sponsor, it resulted in any of the following outcomes: resulted in death, was life-threatening, resulted in persistent or significant disability/incapacity or substantial disruption of the ability to conduct normal life functions, resulted in congenital anomaly or birth defect, required inpatient hospitalization or led to prolongation of hospitalization, other medically important events. Drug-related AEs are AEs where causal relationships were at least a reasonable possibility as determined by the investigator. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Participants With Testosterone Levels Less Than (<) 20, 20-50 and Greater Than (>) 50 Nanogram Per Deciliter (ng/dL) at Month 12 | Month 12 | Testosterone level was summarized based on the percentage of participants with \< 20 ng/dL, 20 to 50 ng/dL and \> 50 ng/dL. |
| Percentage of Participants With Testosterone Levels < 20, 20-50 and > 50 ng/dL at Month 18 | Month 18 | Testosterone level was summarized based on the percentage of participants with \< 20 ng/dL, 20 to 50 ng/dL and \> 50 ng/dL. |
| Time to PSA Progression | From first dose of study drug up to PSA progression (18 months) | Time to PSA progression was defined as (date of ≥25 percentage (%) increase and ≥ 2 ng/mL absolute increase) - (date of first administration of ELIGARD 22.5 mg)/30, where PSA progression was defiined as 25% or greater increase and an absolute increase of 2 ng/mL, and confirmed by a second value at least 3 weeks later. Participants with more than 1 qualifying PSA progression were counted only once, and the earlier progression was accounted for time to progression analysis. |
| Percentage of Participants With Greater Than or Equal to (≥) 30% PSA Percent Reduction From Baseline at Month 3, 6, 9, 12, 15, and 18 | Months 3, 6, 9, 12, 15 and 18 | PSA percent reduction (%) = (\[PSA tested- baseline PSA\]/baseline PSA)\*100%. PSA level was summarized based on time to PSA progression and PSA percent reduction by ≥ 30% with respect to the level at baseline. Participants with more than 1 qualifying PSA progression were counted only once, and the earlier progression was accounted for time to progression analysis. PSA progression was defined as 25% or greater increase and an absolute increase of 2 nanogram per milliliter (ng/mL), and confirmed by a second value at least 3 weeks later. |
| Percentage of Participants With ≥50% PSA Percent Reduction From Baseline at Month 3, 6, 9, 12, 15, and 18 | Months 3, 6, 9, 12, 15 and 18 | PSA percent reduction (%) = (\[PSA tested- baseline PSA\]/baseline PSA)\*100%. PSA level was summarized based on time to PSA progression and PSA percent reduction by ≥ 50% with respect to the level at baseline. Participants with more than 1 qualifying PSA progression were counted only once, and the earlier progression was accounted for time to progression analysis. PSA progression was defined as 25% or greater increase and an absolute increase of 2 ng/mL, and confirmed by a second value at least 3 weeks later. |
| Percentage of Participants With ≥90% PSA Percent Reduction From Baseline at Month 3, 6, 9, 12, 15, and 18 | Months 3, 6, 9, 12, 15 and 18 | PSA percent reduction (%) = (\[PSA tested- baseline PSA\]/baseline PSA)\*100%. PSA level was summarized based on time to PSA progression and PSA percent reduction by ≥ 90%, with respect to the level at baseline. Participants with more than 1 qualifying PSA progression were counted only once, and the earlier progression was accounted for time to progression analysis. PSA progression was defined as 25% or greater increase and an absolute increase of 2 ng/mL, and confirmed by a second value at least 3 weeks later. |
| Change From Baseline in EQ-5D-5L Health State Utility Index Score (Japan) at Months 6, 12 and 18 | Baseline, months 6, 12 and 18 | EQ-5D-5L is a standardized instrument for use as a measure of health outcome and provides a simple descriptive profile and a single index value for health status. EQ-5D-5L is designed for self-completion by respondents and consists of 2 pages comprising the following 5 dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension of the EQ-5D-5L has 5 levels (no problems, slight problems, moderate problems, severe problems, and extreme problems) and the participant was asked to indicate his health state by ticking the box with the most appropriate statement. Index scores were generated using Japan value sets. Scores ranged from -0.111 to 1. Higher scores indicate better health state. |
| Change From Baseline in EQ-5D-5L Health Status Utility Index Score (UK) at Months 6, 12 and 18 | Baseline, months 6, 12 and 18 | EQ-5D-5L is a standardized instrument for use as a measure of health outcome and provides a simple descriptive profile and a single index value for health status. EQ-5D-5L is designed for self-completion by respondents and consists of 2 pages comprising the following 5 dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension of the EQ-5D-5L has 5 levels (no problems, slight problems, moderate problems, severe problems, and extreme problems) and the participant was asked to indicate his health state by ticking the box with the most appropriate statement. Index scores were generated using UK value sets. Scores ranged from -0.594 to 1. Higher scores indicate better health state. |
| Change From Baseline in EQ-5D-5L Health Status Utility Index Score (US) at Months 6, 12 and 18 | Baseline, months 6, 12 and 18 | EQ-5D-5L is a standardized instrument for use as a measure of health outcome and provides a simple descriptive profile and a single index value for health status. EQ-5D-5L is designed for self-completion by respondents and consists of 2 pages comprising the following 5 dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension of the EQ-5D-5L has 5 levels (no problems, slight problems, moderate problems, severe problems, and extreme problems) and the participants was asked to indicate his health state by ticking the box with the most appropriate statement. Index scores were generated using US value sets. Scores ranged from -0.109 to 1. Higher scores indicate better health state. |
| Change From Baseline in EQ-5D02-EQ-VAS Score at Months 6, 12 and 18 | Baseline, months 6, 12 and 18 | The EQ5D02-EQ-VAS is a vertical VAS with values between 0 (worst imaginable health) and 100 (best imaginable health), on which participants provide a global assessment of their health. Higher score indicate better health state. |
| Change From Baseline in EORTC QLQ-PR25 Score at Months 6, 12 and 18 | Baseline, months 6, 12 and 18 | EORTC QLQ-PR25 is a prostate cancer module for the assessment of health-related quality of life (HRQoL). EORTC QLQ-PR25 is designed for self-completion by respondents and assesses urinary symptoms, bowel symptoms, treatment-related symptoms and sexual activity and functioning. The rule of scoring for EORTC QLQ-PR25 follows instruction of EORTC QLQ-PR25 Scoring Manual 2.0. It consist of 25 questions distributed on 6 domains: urinary symptoms (8 items), incontinence aid (1 item), bowel symptoms (4 items), hormonal treatment-related symptoms (HTRS) (6 items), sexual activity (2 items), and sexual functioning (4 items). Questions used 4 point scale (1 'Not at all' to 4 'Very much'). All raw domain scores are linearly transformed to a 0-100 scale, with higher scores reflecting either more symptoms (urinary, bowel, hormonal treatment-related symptoms) or higher levels of activity or functioning (sexual). |
Countries
Hong Kong, Indonesia, Malaysia, Philippines, Singapore, Taiwan, Thailand, Vietnam
Participant flow
Recruitment details
Asian male participants above the age of 18 years with biopsy-proven prostate adenocarcinoma who fulfill the eligibility criteria were enrolled in this study.
Pre-assignment details
107 participants were enrolled and 106 participants received treatment.
Participants by arm
| Arm | Count |
|---|---|
| Leuprolide Acetate 22.5 Milligrams (mg) Participants received 22.5 mg of leuprolide acetate (eligard) by subcutaneous injection at baseline, month 3, 6, 9, 12 and 15. | 106 |
| Total | 106 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Adverse Event | 2 |
| Overall Study | Death | 9 |
| Overall Study | Lost to Follow-up | 1 |
| Overall Study | Physician Decision | 5 |
| Overall Study | Progressive Disease | 22 |
| Overall Study | Protocol Violation | 2 |
| Overall Study | Withdrawal by Subject | 2 |
Baseline characteristics
| Characteristic | Leuprolide Acetate 22.5 Milligrams (mg) |
|---|---|
| Age, Continuous | 72.2 Years STANDARD_DEVIATION 7.43 |
| EQ-5D-5L Index Score (UK) | 0.8040 Score on a scale STANDARD_DEVIATION 0.25853 |
| EQ-5D-5L Index Score (US) | 0.8503 Score on a scale STANDARD_DEVIATION 0.1836 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 0 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 0 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 106 Participants |
| European Organization for Research & Treatment of Cancer Quality of Life Questionnaire EORTCQLQ-PR25 Bowel Symptoms | 7.06 Score on a scale STANDARD_DEVIATION 11.011 |
| European Organization for Research & Treatment of Cancer Quality of Life Questionnaire EORTCQLQ-PR25 Hormonal Treatment Related Symptoms | 9.84 Score on a scale STANDARD_DEVIATION 11.69 |
| European Organization for Research & Treatment of Cancer Quality of Life Questionnaire EORTCQLQ-PR25 Incontinence Aid | 14.55 Score on a scale STANDARD_DEVIATION 26.265 |
| European Organization for Research & Treatment of Cancer Quality of Life Questionnaire EORTCQLQ-PR25 Sexual Function | 76.96 Score on a scale STANDARD_DEVIATION 7.447 |
| European Organization for Research & Treatment of Cancer Quality of Life Questionnaire EORTCQLQ-PR25 Sexually Active | 13.02 Score on a scale STANDARD_DEVIATION 21.556 |
| European Organization for Research & Treatment of Cancer Quality of Life Questionnaire EORTCQLQ-PR25 Urinary Symptoms | 29.38 Score on a scale STANDARD_DEVIATION 19.611 |
| EuroQol-5 Dimension-5 Level (EQ-5D-5L) Health State Utility Index Score (Japan) | 0.8162 Score on a scale STANDARD_DEVIATION 0.18916 |
| EuroQol-5 Dimension-5 Level Health State Utility Index Visual Analogue Scale (EQ-5D02-EQ-VAS) | 78.8 Score on a scale STANDARD_DEVIATION 13.04 |
| Prostate-specific antigen (PSA) Level at Initial Diagnosis | 315.05 Nanogram per milliliter (ng/mL) STANDARD_DEVIATION 989.552 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 106 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) White | 0 Participants |
| Sex: Female, Male Female | 0 Participants |
| Sex: Female, Male Male | 106 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 9 / 106 |
| other Total, other adverse events | 42 / 106 |
| serious Total, serious adverse events | 31 / 106 |
Outcome results
Primary
Number of Participants With Eligard Related Adverse Events (AE)
An AE was defined as any untoward medical occurrence in a participant administered a study drug or had undergone study procedures that did not necessarily have a causal relationship with this treatment. An AE was considered to be serious if, in the view of either the investigator or sponsor, it resulted in any of the following outcomes: resulted in death, was life-threatening, resulted in persistent or significant disability/incapacity or substantial disruption of the ability to conduct normal life functions, resulted in congenital anomaly or birth defect, required inpatient hospitalization or led to prolongation of hospitalization, other medically important events. Drug-related AEs are AEs where causal relationships were at least a reasonable possibility as determined by the investigator.
Time frame: From first dose of study drug up to 18 months
Population: SAF population
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Leuprolide Acetate 22.5 mg | Number of Participants With Eligard Related Adverse Events (AE) | Drug-related adverse event | 15 Participants |
| Leuprolide Acetate 22.5 mg | Number of Participants With Eligard Related Adverse Events (AE) | Drug-related serious adverse event | 2 Participants |
Secondary
Change From Baseline in EORTC QLQ-PR25 Score at Months 6, 12 and 18
EORTC QLQ-PR25 is a prostate cancer module for the assessment of health-related quality of life (HRQoL). EORTC QLQ-PR25 is designed for self-completion by respondents and assesses urinary symptoms, bowel symptoms, treatment-related symptoms and sexual activity and functioning. The rule of scoring for EORTC QLQ-PR25 follows instruction of EORTC QLQ-PR25 Scoring Manual 2.0. It consist of 25 questions distributed on 6 domains: urinary symptoms (8 items), incontinence aid (1 item), bowel symptoms (4 items), hormonal treatment-related symptoms (HTRS) (6 items), sexual activity (2 items), and sexual functioning (4 items). Questions used 4 point scale (1 'Not at all' to 4 'Very much'). All raw domain scores are linearly transformed to a 0-100 scale, with higher scores reflecting either more symptoms (urinary, bowel, hormonal treatment-related symptoms) or higher levels of activity or functioning (sexual).
Time frame: Baseline, months 6, 12 and 18
Population: FAS population with available data.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Leuprolide Acetate 22.5 mg | Change From Baseline in EORTC QLQ-PR25 Score at Months 6, 12 and 18 | Week 6: Incontinence Aid | -5.21 Score on a scale | Standard Deviation 28.22 |
| Leuprolide Acetate 22.5 mg | Change From Baseline in EORTC QLQ-PR25 Score at Months 6, 12 and 18 | Week 12: Bowel Symptoms | -2.66 Score on a scale | Standard Deviation 9.533 |
| Leuprolide Acetate 22.5 mg | Change From Baseline in EORTC QLQ-PR25 Score at Months 6, 12 and 18 | Week 6: Urinary Symptoms | -4.84 Score on a scale | Standard Deviation 15.669 |
| Leuprolide Acetate 22.5 mg | Change From Baseline in EORTC QLQ-PR25 Score at Months 6, 12 and 18 | Week 6: Bowel Symptoms | -2.17 Score on a scale | Standard Deviation 8.311 |
| Leuprolide Acetate 22.5 mg | Change From Baseline in EORTC QLQ-PR25 Score at Months 6, 12 and 18 | Week 6: HTRS | 3.27 Score on a scale | Standard Deviation 11.008 |
| Leuprolide Acetate 22.5 mg | Change From Baseline in EORTC QLQ-PR25 Score at Months 6, 12 and 18 | Week 6: Sexually Active | -6.08 Score on a scale | Standard Deviation 17.29 |
| Leuprolide Acetate 22.5 mg | Change From Baseline in EORTC QLQ-PR25 Score at Months 6, 12 and 18 | Week 6: Sexual Function | -1.44 Score on a scale | Standard Deviation 11.362 |
| Leuprolide Acetate 22.5 mg | Change From Baseline in EORTC QLQ-PR25 Score at Months 6, 12 and 18 | Week 12: Urinary Symptoms | -6.93 Score on a scale | Standard Deviation 15.237 |
| Leuprolide Acetate 22.5 mg | Change From Baseline in EORTC QLQ-PR25 Score at Months 6, 12 and 18 | Week 12: Incontinence Aid | -11.11 Score on a scale | Standard Deviation 32.338 |
| Leuprolide Acetate 22.5 mg | Change From Baseline in EORTC QLQ-PR25 Score at Months 6, 12 and 18 | Week 12: HTRS | 2.14 Score on a scale | Standard Deviation 9.959 |
| Leuprolide Acetate 22.5 mg | Change From Baseline in EORTC QLQ-PR25 Score at Months 6, 12 and 18 | Week 12: Sexually Active | -5.07 Score on a scale | Standard Deviation 16.983 |
| Leuprolide Acetate 22.5 mg | Change From Baseline in EORTC QLQ-PR25 Score at Months 6, 12 and 18 | Week 12: Sexual Function | -2.99 Score on a scale | Standard Deviation 14.823 |
| Leuprolide Acetate 22.5 mg | Change From Baseline in EORTC QLQ-PR25 Score at Months 6, 12 and 18 | Week 18: Urinary Symptoms | -4.06 Score on a scale | Standard Deviation 15.37 |
| Leuprolide Acetate 22.5 mg | Change From Baseline in EORTC QLQ-PR25 Score at Months 6, 12 and 18 | Week 18: Incontinence Aid | 1.67 Score on a scale | Standard Deviation 31.484 |
| Leuprolide Acetate 22.5 mg | Change From Baseline in EORTC QLQ-PR25 Score at Months 6, 12 and 18 | Week 18: Bowel Symptoms | 0.31 Score on a scale | Standard Deviation 9.036 |
| Leuprolide Acetate 22.5 mg | Change From Baseline in EORTC QLQ-PR25 Score at Months 6, 12 and 18 | Week 18: HTRS | 4.68 Score on a scale | Standard Deviation 11.064 |
| Leuprolide Acetate 22.5 mg | Change From Baseline in EORTC QLQ-PR25 Score at Months 6, 12 and 18 | Week 18: Sexually Active | -3.54 Score on a scale | Standard Deviation 23.334 |
| Leuprolide Acetate 22.5 mg | Change From Baseline in EORTC QLQ-PR25 Score at Months 6, 12 and 18 | Week 18: Sexual Function | -8.52 Score on a scale | Standard Deviation 15.969 |
Secondary
Change From Baseline in EQ-5D02-EQ-VAS Score at Months 6, 12 and 18
The EQ5D02-EQ-VAS is a vertical VAS with values between 0 (worst imaginable health) and 100 (best imaginable health), on which participants provide a global assessment of their health. Higher score indicate better health state.
Time frame: Baseline, months 6, 12 and 18
Population: FAS population with available data.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Leuprolide Acetate 22.5 mg | Change From Baseline in EQ-5D02-EQ-VAS Score at Months 6, 12 and 18 | Month 6 | 1.3 Score on a scale | Standard Deviation 14.72 |
| Leuprolide Acetate 22.5 mg | Change From Baseline in EQ-5D02-EQ-VAS Score at Months 6, 12 and 18 | Month 9 | 2.1 Score on a scale | Standard Deviation 11.92 |
| Leuprolide Acetate 22.5 mg | Change From Baseline in EQ-5D02-EQ-VAS Score at Months 6, 12 and 18 | Month 18 | 2.0 Score on a scale | Standard Deviation 15.65 |
Secondary
Change From Baseline in EQ-5D-5L Health State Utility Index Score (Japan) at Months 6, 12 and 18
EQ-5D-5L is a standardized instrument for use as a measure of health outcome and provides a simple descriptive profile and a single index value for health status. EQ-5D-5L is designed for self-completion by respondents and consists of 2 pages comprising the following 5 dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension of the EQ-5D-5L has 5 levels (no problems, slight problems, moderate problems, severe problems, and extreme problems) and the participant was asked to indicate his health state by ticking the box with the most appropriate statement. Index scores were generated using Japan value sets. Scores ranged from -0.111 to 1. Higher scores indicate better health state.
Time frame: Baseline, months 6, 12 and 18
Population: FAS population with available data.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Leuprolide Acetate 22.5 mg | Change From Baseline in EQ-5D-5L Health State Utility Index Score (Japan) at Months 6, 12 and 18 | Month 6 | -0.0047 Score on a scale | Standard Deviation 0.16874 |
| Leuprolide Acetate 22.5 mg | Change From Baseline in EQ-5D-5L Health State Utility Index Score (Japan) at Months 6, 12 and 18 | Month 12 | -0.0093 Score on a scale | Standard Deviation 0.14456 |
| Leuprolide Acetate 22.5 mg | Change From Baseline in EQ-5D-5L Health State Utility Index Score (Japan) at Months 6, 12 and 18 | Month 18 | -0.0262 Score on a scale | Standard Deviation 0.1752 |
Secondary
Change From Baseline in EQ-5D-5L Health Status Utility Index Score (UK) at Months 6, 12 and 18
EQ-5D-5L is a standardized instrument for use as a measure of health outcome and provides a simple descriptive profile and a single index value for health status. EQ-5D-5L is designed for self-completion by respondents and consists of 2 pages comprising the following 5 dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension of the EQ-5D-5L has 5 levels (no problems, slight problems, moderate problems, severe problems, and extreme problems) and the participant was asked to indicate his health state by ticking the box with the most appropriate statement. Index scores were generated using UK value sets. Scores ranged from -0.594 to 1. Higher scores indicate better health state.
Time frame: Baseline, months 6, 12 and 18
Population: FAS population with available data.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Leuprolide Acetate 22.5 mg | Change From Baseline in EQ-5D-5L Health Status Utility Index Score (UK) at Months 6, 12 and 18 | Month 6 | 0.0055 Score on a scale | Standard Deviation 0.21662 |
| Leuprolide Acetate 22.5 mg | Change From Baseline in EQ-5D-5L Health Status Utility Index Score (UK) at Months 6, 12 and 18 | Month 9 | -0.0051 Score on a scale | Standard Deviation 0.16493 |
| Leuprolide Acetate 22.5 mg | Change From Baseline in EQ-5D-5L Health Status Utility Index Score (UK) at Months 6, 12 and 18 | Month 18 | -0.0259 Score on a scale | Standard Deviation 0.23831 |
Secondary
Change From Baseline in EQ-5D-5L Health Status Utility Index Score (US) at Months 6, 12 and 18
EQ-5D-5L is a standardized instrument for use as a measure of health outcome and provides a simple descriptive profile and a single index value for health status. EQ-5D-5L is designed for self-completion by respondents and consists of 2 pages comprising the following 5 dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension of the EQ-5D-5L has 5 levels (no problems, slight problems, moderate problems, severe problems, and extreme problems) and the participants was asked to indicate his health state by ticking the box with the most appropriate statement. Index scores were generated using US value sets. Scores ranged from -0.109 to 1. Higher scores indicate better health state.
Time frame: Baseline, months 6, 12 and 18
Population: FAS population with available data.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Leuprolide Acetate 22.5 mg | Change From Baseline in EQ-5D-5L Health Status Utility Index Score (US) at Months 6, 12 and 18 | Month 6 | 0.0017 Score on a scale | Standard Deviation 0.15819 |
| Leuprolide Acetate 22.5 mg | Change From Baseline in EQ-5D-5L Health Status Utility Index Score (US) at Months 6, 12 and 18 | Month 9 | -0.0047 Score on a scale | Standard Deviation 0.12477 |
| Leuprolide Acetate 22.5 mg | Change From Baseline in EQ-5D-5L Health Status Utility Index Score (US) at Months 6, 12 and 18 | Month 18 | -0.0191 Score on a scale | Standard Deviation 0.16934 |
Secondary
Percentage of Participants With ≥50% PSA Percent Reduction From Baseline at Month 3, 6, 9, 12, 15, and 18
PSA percent reduction (%) = (\[PSA tested- baseline PSA\]/baseline PSA)\*100%. PSA level was summarized based on time to PSA progression and PSA percent reduction by ≥ 50% with respect to the level at baseline. Participants with more than 1 qualifying PSA progression were counted only once, and the earlier progression was accounted for time to progression analysis. PSA progression was defined as 25% or greater increase and an absolute increase of 2 ng/mL, and confirmed by a second value at least 3 weeks later.
Time frame: Months 3, 6, 9, 12, 15 and 18
Population: FAS population with available data.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Leuprolide Acetate 22.5 mg | Percentage of Participants With ≥50% PSA Percent Reduction From Baseline at Month 3, 6, 9, 12, 15, and 18 | Month 18 | 88.8 Percentage of participants |
| Leuprolide Acetate 22.5 mg | Percentage of Participants With ≥50% PSA Percent Reduction From Baseline at Month 3, 6, 9, 12, 15, and 18 | Month 3 | 89.2 Percentage of participants |
| Leuprolide Acetate 22.5 mg | Percentage of Participants With ≥50% PSA Percent Reduction From Baseline at Month 3, 6, 9, 12, 15, and 18 | Month 6 | 91.7 Percentage of participants |
| Leuprolide Acetate 22.5 mg | Percentage of Participants With ≥50% PSA Percent Reduction From Baseline at Month 3, 6, 9, 12, 15, and 18 | Month 9 | 91.6 Percentage of participants |
| Leuprolide Acetate 22.5 mg | Percentage of Participants With ≥50% PSA Percent Reduction From Baseline at Month 3, 6, 9, 12, 15, and 18 | Month 12 | 94.2 Percentage of participants |
| Leuprolide Acetate 22.5 mg | Percentage of Participants With ≥50% PSA Percent Reduction From Baseline at Month 3, 6, 9, 12, 15, and 18 | Month 15 | 96.9 Percentage of participants |
Secondary
Percentage of Participants With ≥90% PSA Percent Reduction From Baseline at Month 3, 6, 9, 12, 15, and 18
PSA percent reduction (%) = (\[PSA tested- baseline PSA\]/baseline PSA)\*100%. PSA level was summarized based on time to PSA progression and PSA percent reduction by ≥ 90%, with respect to the level at baseline. Participants with more than 1 qualifying PSA progression were counted only once, and the earlier progression was accounted for time to progression analysis. PSA progression was defined as 25% or greater increase and an absolute increase of 2 ng/mL, and confirmed by a second value at least 3 weeks later.
Time frame: Months 3, 6, 9, 12, 15 and 18
Population: FAS population with available data.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Leuprolide Acetate 22.5 mg | Percentage of Participants With ≥90% PSA Percent Reduction From Baseline at Month 3, 6, 9, 12, 15, and 18 | Month 3 | 69.6 Percentage of participants |
| Leuprolide Acetate 22.5 mg | Percentage of Participants With ≥90% PSA Percent Reduction From Baseline at Month 3, 6, 9, 12, 15, and 18 | Month 6 | 77.1 Percentage of participants |
| Leuprolide Acetate 22.5 mg | Percentage of Participants With ≥90% PSA Percent Reduction From Baseline at Month 3, 6, 9, 12, 15, and 18 | Month 9 | 77.1 Percentage of participants |
| Leuprolide Acetate 22.5 mg | Percentage of Participants With ≥90% PSA Percent Reduction From Baseline at Month 3, 6, 9, 12, 15, and 18 | Month 12 | 81.2 Percentage of participants |
| Leuprolide Acetate 22.5 mg | Percentage of Participants With ≥90% PSA Percent Reduction From Baseline at Month 3, 6, 9, 12, 15, and 18 | Month 15 | 79.7 Percentage of participants |
| Leuprolide Acetate 22.5 mg | Percentage of Participants With ≥90% PSA Percent Reduction From Baseline at Month 3, 6, 9, 12, 15, and 18 | Month 18 | 68.5 Percentage of participants |
Secondary
Percentage of Participants With Greater Than or Equal to (≥) 30% PSA Percent Reduction From Baseline at Month 3, 6, 9, 12, 15, and 18
PSA percent reduction (%) = (\[PSA tested- baseline PSA\]/baseline PSA)\*100%. PSA level was summarized based on time to PSA progression and PSA percent reduction by ≥ 30% with respect to the level at baseline. Participants with more than 1 qualifying PSA progression were counted only once, and the earlier progression was accounted for time to progression analysis. PSA progression was defined as 25% or greater increase and an absolute increase of 2 nanogram per milliliter (ng/mL), and confirmed by a second value at least 3 weeks later.
Time frame: Months 3, 6, 9, 12, 15 and 18
Population: FAS population with available data.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Leuprolide Acetate 22.5 mg | Percentage of Participants With Greater Than or Equal to (≥) 30% PSA Percent Reduction From Baseline at Month 3, 6, 9, 12, 15, and 18 | Month 3 | 96.1 Percentage of participants |
| Leuprolide Acetate 22.5 mg | Percentage of Participants With Greater Than or Equal to (≥) 30% PSA Percent Reduction From Baseline at Month 3, 6, 9, 12, 15, and 18 | Month 6 | 93.8 Percentage of participants |
| Leuprolide Acetate 22.5 mg | Percentage of Participants With Greater Than or Equal to (≥) 30% PSA Percent Reduction From Baseline at Month 3, 6, 9, 12, 15, and 18 | Month 9 | 92.8 Percentage of participants |
| Leuprolide Acetate 22.5 mg | Percentage of Participants With Greater Than or Equal to (≥) 30% PSA Percent Reduction From Baseline at Month 3, 6, 9, 12, 15, and 18 | Month 12 | 97.1 Percentage of participants |
| Leuprolide Acetate 22.5 mg | Percentage of Participants With Greater Than or Equal to (≥) 30% PSA Percent Reduction From Baseline at Month 3, 6, 9, 12, 15, and 18 | Month 15 | 98.4 Percentage of participants |
| Leuprolide Acetate 22.5 mg | Percentage of Participants With Greater Than or Equal to (≥) 30% PSA Percent Reduction From Baseline at Month 3, 6, 9, 12, 15, and 18 | Month 18 | 91.0 Percentage of participants |
Secondary
Percentage of Participants With Testosterone Levels < 20, 20-50 and > 50 ng/dL at Month 18
Testosterone level was summarized based on the percentage of participants with \< 20 ng/dL, 20 to 50 ng/dL and \> 50 ng/dL.
Time frame: Month 18
Population: FAS population
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Leuprolide Acetate 22.5 mg | Percentage of Participants With Testosterone Levels < 20, 20-50 and > 50 ng/dL at Month 18 | > 50 ng/dL | 1.9 Percentage of participants |
| Leuprolide Acetate 22.5 mg | Percentage of Participants With Testosterone Levels < 20, 20-50 and > 50 ng/dL at Month 18 | < 20 ng/dL | 61.9 Percentage of participants |
| Leuprolide Acetate 22.5 mg | Percentage of Participants With Testosterone Levels < 20, 20-50 and > 50 ng/dL at Month 18 | 20 - 50 ng/dL | 16.2 Percentage of participants |
Secondary
Percentage of Participants With Testosterone Levels Less Than (<) 20, 20-50 and Greater Than (>) 50 Nanogram Per Deciliter (ng/dL) at Month 12
Testosterone level was summarized based on the percentage of participants with \< 20 ng/dL, 20 to 50 ng/dL and \> 50 ng/dL.
Time frame: Month 12
Population: FAS population
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Leuprolide Acetate 22.5 mg | Percentage of Participants With Testosterone Levels Less Than (<) 20, 20-50 and Greater Than (>) 50 Nanogram Per Deciliter (ng/dL) at Month 12 | < 20 ng/dL | 51.4 Percentage of participants |
| Leuprolide Acetate 22.5 mg | Percentage of Participants With Testosterone Levels Less Than (<) 20, 20-50 and Greater Than (>) 50 Nanogram Per Deciliter (ng/dL) at Month 12 | 20 - 50 ng/dL | 12.4 Percentage of participants |
| Leuprolide Acetate 22.5 mg | Percentage of Participants With Testosterone Levels Less Than (<) 20, 20-50 and Greater Than (>) 50 Nanogram Per Deciliter (ng/dL) at Month 12 | > 50 ng/dL | 1.9 Percentage of participants |
Secondary
Time to PSA Progression
Time to PSA progression was defined as (date of ≥25 percentage (%) increase and ≥ 2 ng/mL absolute increase) - (date of first administration of ELIGARD 22.5 mg)/30, where PSA progression was defiined as 25% or greater increase and an absolute increase of 2 ng/mL, and confirmed by a second value at least 3 weeks later. Participants with more than 1 qualifying PSA progression were counted only once, and the earlier progression was accounted for time to progression analysis.
Time frame: From first dose of study drug up to PSA progression (18 months)
Population: FAS population with available data.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Leuprolide Acetate 22.5 mg | Time to PSA Progression | 8.80 Months |