Trial Outcomes & Findings for A Study of ELIGARD® in Hormone-dependent Prostate Cancer Patients (NCT NCT03035032)

NCT ID: NCT03035032

Last Updated: 2024-11-26

Results Overview

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.

• Recruitment status: COMPLETED
• Study phase: PHASE4
• Target enrollment: 107 participants
• Primary outcome timeframe: From first dose of study drug up to 18 months
• Results posted on: 2024-11-26

Participant Flow

Asian male participants above the age of 18 years with biopsy-proven prostate adenocarcinoma who fulfill the eligibility criteria were enrolled in this study.

107 participants were enrolled and 106 participants received treatment.

Participant milestones

Measure	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.
Overall Study STARTED	107
Overall Study COMPLETED	64
Overall Study NOT COMPLETED	43

Reasons for withdrawal

Measure	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.
Overall Study Adverse Event	2
Overall Study Death	9
Overall Study Lost to Follow-up	1
Overall Study Progressive Disease	22
Overall Study Protocol Violation	2
Overall Study Withdrawal by Subject	2
Overall Study Physician Decision	5

Baseline Characteristics

SAF population with available data.

Baseline characteristics by cohort

Measure	Leuprolide Acetate 22.5 Milligrams (mg) n=106 Participants Participants received 22.5 mg of leuprolide acetate (eligard) by subcutaneous injection at baseline, month 3, 6, 9, 12 and 15.
Age, Continuous	72.2 Years STANDARD_DEVIATION 7.43 • n=106 Participants
Sex: Female, Male Female	0 Participants n=106 Participants
Sex: Female, Male Male	106 Participants n=106 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants n=106 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	0 Participants n=106 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	106 Participants n=106 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=106 Participants
Race (NIH/OMB) Asian	106 Participants n=106 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=106 Participants
Race (NIH/OMB) Black or African American	0 Participants n=106 Participants
Race (NIH/OMB) White	0 Participants n=106 Participants
Race (NIH/OMB) More than one race	0 Participants n=106 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=106 Participants
Prostate-specific antigen (PSA) Level at Initial Diagnosis	315.05 Nanogram per milliliter (ng/mL) STANDARD_DEVIATION 989.552 • n=103 Participants • SAF population with available data.
EuroQol-5 Dimension-5 Level (EQ-5D-5L) Health State Utility Index Score (Japan)	0.8162 Score on a scale STANDARD_DEVIATION 0.18916 • n=105 Participants • Full analysis set (FAS): The FAS consisted of all participants who were enrolled and received at least 1 dose of ELIGARD and have at least 1 post baseline measurement of PSA and testosterone levels.
EQ-5D-5L Index Score (UK)	0.8040 Score on a scale STANDARD_DEVIATION 0.25853 • n=105 Participants • FAS population
EQ-5D-5L Index Score (US)	0.8503 Score on a scale STANDARD_DEVIATION 0.18360 • n=105 Participants • FAS population
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 • n=105 Participants • FAS population
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 • n=102 Participants • FAS population with available data.
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 • n=55 Participants • FAS population with available data.
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 • n=105 Participants • FAS population with available data.
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 11.690 • n=105 Participants • FAS population with available data.
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 • n=105 Participants • FAS population with available data.
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 • n=51 Participants • FAS population with available data.

PRIMARY outcome

Timeframe: From first dose of study drug up to 18 months

Population: SAF population

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.

Outcome measures

Measure	Leuprolide Acetate 22.5 mg n=106 Participants Participants received 22.5 mg of leuprolide acetate (eligard) by subcutaneous injection at baseline, month 3, 6, 9, 12 and 15.
Number of Participants With Eligard Related Adverse Events (AE) Drug-related adverse event	15 Participants
Number of Participants With Eligard Related Adverse Events (AE) Drug-related serious adverse event	2 Participants

SECONDARY outcome

Timeframe: Month 12

Population: FAS population

Testosterone level was summarized based on the percentage of participants with < 20 ng/dL, 20 to 50 ng/dL and > 50 ng/dL.

Outcome measures

Measure	Leuprolide Acetate 22.5 mg n=105 Participants Participants received 22.5 mg of leuprolide acetate (eligard) by subcutaneous injection at baseline, month 3, 6, 9, 12 and 15.
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
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
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 outcome

Timeframe: Month 18

Population: FAS population

Testosterone level was summarized based on the percentage of participants with < 20 ng/dL, 20 to 50 ng/dL and > 50 ng/dL.

Outcome measures

Measure	Leuprolide Acetate 22.5 mg n=105 Participants Participants received 22.5 mg of leuprolide acetate (eligard) by subcutaneous injection at baseline, month 3, 6, 9, 12 and 15.
Percentage of Participants With Testosterone Levels < 20, 20-50 and > 50 ng/dL at Month 18 < 20 ng/dL	61.9 Percentage of participants
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
Percentage of Participants With Testosterone Levels < 20, 20-50 and > 50 ng/dL at Month 18 > 50 ng/dL	1.9 Percentage of participants

SECONDARY outcome

Timeframe: From first dose of study drug up to PSA progression (18 months)

Population: FAS population with available data.

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.

Outcome measures

Measure	Leuprolide Acetate 22.5 mg n=25 Participants Participants received 22.5 mg of leuprolide acetate (eligard) by subcutaneous injection at baseline, month 3, 6, 9, 12 and 15.
Time to PSA Progression	8.80 Months Interval 6.1 to 9.2

SECONDARY outcome

Timeframe: Months 3, 6, 9, 12, 15 and 18

Population: FAS population with available data.

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.

Outcome measures

Measure	Leuprolide Acetate 22.5 mg n=102 Participants Participants received 22.5 mg of leuprolide acetate (eligard) by subcutaneous injection at baseline, month 3, 6, 9, 12 and 15.
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
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
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
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
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
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 outcome

Timeframe: Months 3, 6, 9, 12, 15 and 18

Population: FAS population with available data.

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.

Outcome measures

Measure	Leuprolide Acetate 22.5 mg n=102 Participants Participants received 22.5 mg of leuprolide acetate (eligard) by subcutaneous injection at baseline, month 3, 6, 9, 12 and 15.
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
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
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
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
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
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

SECONDARY outcome

Timeframe: Months 3, 6, 9, 12, 15 and 18

Population: FAS population with available data.

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.

Outcome measures

Measure	Leuprolide Acetate 22.5 mg n=102 Participants Participants received 22.5 mg of leuprolide acetate (eligard) by subcutaneous injection at baseline, month 3, 6, 9, 12 and 15.
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
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
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
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
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
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 outcome

Timeframe: Baseline, months 6, 12 and 18

Population: FAS population with available data.

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.

Outcome measures

Measure	Leuprolide Acetate 22.5 mg n=95 Participants Participants received 22.5 mg of leuprolide acetate (eligard) by subcutaneous injection at baseline, month 3, 6, 9, 12 and 15.
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
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
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 0.17520

SECONDARY outcome

Timeframe: Baseline, months 6, 12 and 18

Population: FAS population with available data.

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.

Outcome measures

Measure	Leuprolide Acetate 22.5 mg n=95 Participants Participants received 22.5 mg of leuprolide acetate (eligard) by subcutaneous injection at baseline, month 3, 6, 9, 12 and 15.
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
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
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 outcome

Timeframe: Baseline, months 6, 12 and 18

Population: FAS population with available data.

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.

Outcome measures

Measure	Leuprolide Acetate 22.5 mg n=95 Participants Participants received 22.5 mg of leuprolide acetate (eligard) by subcutaneous injection at baseline, month 3, 6, 9, 12 and 15.
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
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
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 outcome

Timeframe: Baseline, months 6, 12 and 18

Population: FAS population with available data.

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.

Outcome measures

Measure	Leuprolide Acetate 22.5 mg n=96 Participants Participants received 22.5 mg of leuprolide acetate (eligard) by subcutaneous injection at baseline, month 3, 6, 9, 12 and 15.
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
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
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 outcome

Timeframe: Baseline, months 6, 12 and 18

Population: FAS population with available data.

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).

Outcome measures

Measure	Leuprolide Acetate 22.5 mg n=96 Participants Participants received 22.5 mg of leuprolide acetate (eligard) by subcutaneous injection at baseline, month 3, 6, 9, 12 and 15.
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
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 28.220
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
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
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 17.290
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
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
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
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
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
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
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
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 15.370
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
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
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
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
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

Adverse Events

Leuprolide Acetate 22.5 mg

Serious events: 31 serious events

Other events: 42 other events

Deaths: 9 deaths

Serious adverse events

Measure	Leuprolide Acetate 22.5 mg n=106 participants at risk Participants received 22.5 mg of leuprolide acetate (eligard) by subcutaneous injection at baseline, month 3, 6, 9, 12 and 15.
Blood and lymphatic system disorders Anaemia	1.9% 2/106 • Number of events 2 • From first dose of study drug up to 18 months SAF Population
Cardiac disorders Cardiac failure congestive	0.94% 1/106 • Number of events 1 • From first dose of study drug up to 18 months SAF Population
Gastrointestinal disorders Abdominal wall haematoma	0.94% 1/106 • Number of events 1 • From first dose of study drug up to 18 months SAF Population
Gastrointestinal disorders Anal hypoaesthesia	0.94% 1/106 • Number of events 1 • From first dose of study drug up to 18 months SAF Population
Gastrointestinal disorders Incarcerated inguinal hernia	0.94% 1/106 • Number of events 1 • From first dose of study drug up to 18 months SAF Population
Gastrointestinal disorders Inguinal hernia	0.94% 1/106 • Number of events 1 • From first dose of study drug up to 18 months SAF Population
Gastrointestinal disorders Inguinal hernia, obstructive	0.94% 1/106 • Number of events 1 • From first dose of study drug up to 18 months SAF Population
Gastrointestinal disorders Pancreatitis	0.94% 1/106 • Number of events 1 • From first dose of study drug up to 18 months SAF Population
Gastrointestinal disorders Proctalgia	0.94% 1/106 • Number of events 2 • From first dose of study drug up to 18 months SAF Population
Gastrointestinal disorders Vomiting	0.94% 1/106 • Number of events 1 • From first dose of study drug up to 18 months SAF Population
General disorders Death	2.8% 3/106 • Number of events 3 • From first dose of study drug up to 18 months SAF Population
General disorders Multiple organ dysfunction syndrome	0.94% 1/106 • Number of events 1 • From first dose of study drug up to 18 months SAF Population
General disorders Peripheral swelling	0.94% 1/106 • Number of events 1 • From first dose of study drug up to 18 months SAF Population
Infections and infestations Appendicitis	0.94% 1/106 • Number of events 1 • From first dose of study drug up to 18 months SAF Population
Infections and infestations Gastroenteritis	0.94% 1/106 • Number of events 1 • From first dose of study drug up to 18 months SAF Population
Infections and infestations Pneumonia	3.8% 4/106 • Number of events 5 • From first dose of study drug up to 18 months SAF Population
Infections and infestations Sepsis	0.94% 1/106 • Number of events 1 • From first dose of study drug up to 18 months SAF Population
Infections and infestations Septic shock	0.94% 1/106 • Number of events 1 • From first dose of study drug up to 18 months SAF Population
Infections and infestations Upper respiratory tract infection	0.94% 1/106 • Number of events 1 • From first dose of study drug up to 18 months SAF Population
Infections and infestations Viral upper respiratory tract infection	0.94% 1/106 • Number of events 1 • From first dose of study drug up to 18 months SAF Population
Injury, poisoning and procedural complications Femur fracture	0.94% 1/106 • Number of events 1 • From first dose of study drug up to 18 months SAF Population
Injury, poisoning and procedural complications Spinal compression fracture	0.94% 1/106 • Number of events 1 • From first dose of study drug up to 18 months SAF Population
Investigations Weight decreased	0.94% 1/106 • Number of events 1 • From first dose of study drug up to 18 months SAF Population
Metabolism and nutrition disorders Fluid overload	0.94% 1/106 • Number of events 1 • From first dose of study drug up to 18 months SAF Population
Metabolism and nutrition disorders Hyperglycaemia	0.94% 1/106 • Number of events 1 • From first dose of study drug up to 18 months SAF Population
Musculoskeletal and connective tissue disorders Arthralgia	1.9% 2/106 • Number of events 2 • From first dose of study drug up to 18 months SAF Population
Musculoskeletal and connective tissue disorders Back pain	1.9% 2/106 • Number of events 2 • From first dose of study drug up to 18 months SAF Population
Musculoskeletal and connective tissue disorders Muscular weakness	0.94% 1/106 • Number of events 2 • From first dose of study drug up to 18 months SAF Population
Musculoskeletal and connective tissue disorders Musculoskeletal chest pain	0.94% 1/106 • Number of events 1 • From first dose of study drug up to 18 months SAF Population
Musculoskeletal and connective tissue disorders Pain in extremity	0.94% 1/106 • Number of events 1 • From first dose of study drug up to 18 months SAF Population
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Prostate cancer metastatic	0.94% 1/106 • Number of events 1 • From first dose of study drug up to 18 months SAF Population
Nervous system disorders Dementia	0.94% 1/106 • Number of events 1 • From first dose of study drug up to 18 months SAF Population
Nervous system disorders Haemorrhage intracranial	1.9% 2/106 • Number of events 2 • From first dose of study drug up to 18 months SAF Population
Nervous system disorders Headache	0.94% 1/106 • Number of events 1 • From first dose of study drug up to 18 months SAF Population
Nervous system disorders Neuralgia	1.9% 2/106 • Number of events 2 • From first dose of study drug up to 18 months SAF Population
Nervous system disorders Spinal cord compression	0.94% 1/106 • Number of events 1 • From first dose of study drug up to 18 months SAF Population
Nervous system disorders Syncope	0.94% 1/106 • Number of events 1 • From first dose of study drug up to 18 months SAF Population
Renal and urinary disorders Dysuria	0.94% 1/106 • Number of events 1 • From first dose of study drug up to 18 months SAF Population
Respiratory, thoracic and mediastinal disorders Chronic obstructive pulmonary disease	0.94% 1/106 • Number of events 2 • From first dose of study drug up to 18 months SAF Population
Respiratory, thoracic and mediastinal disorders Dyspnoea	0.94% 1/106 • Number of events 1 • From first dose of study drug up to 18 months SAF Population
Respiratory, thoracic and mediastinal disorders Epistaxis	0.94% 1/106 • Number of events 3 • From first dose of study drug up to 18 months SAF Population
Respiratory, thoracic and mediastinal disorders Pleural effusion	0.94% 1/106 • Number of events 1 • From first dose of study drug up to 18 months SAF Population
Vascular disorders Deep vein thrombosis	0.94% 1/106 • Number of events 1 • From first dose of study drug up to 18 months SAF Population

Other adverse events

Measure	Leuprolide Acetate 22.5 mg n=106 participants at risk Participants received 22.5 mg of leuprolide acetate (eligard) by subcutaneous injection at baseline, month 3, 6, 9, 12 and 15.
Blood and lymphatic system disorders Anaemia	5.7% 6/106 • Number of events 6 • From first dose of study drug up to 18 months SAF Population
Infections and infestations Upper respiratory tract infection	5.7% 6/106 • Number of events 8 • From first dose of study drug up to 18 months SAF Population
Investigations Prostatic specific antigen increased	17.0% 18/106 • Number of events 18 • From first dose of study drug up to 18 months SAF Population
Musculoskeletal and connective tissue disorders Back pain	7.5% 8/106 • Number of events 9 • From first dose of study drug up to 18 months SAF Population
Respiratory, thoracic and mediastinal disorders Cough	9.4% 10/106 • Number of events 14 • From first dose of study drug up to 18 months SAF Population
Vascular disorders Hot flush	7.5% 8/106 • Number of events 8 • From first dose of study drug up to 18 months SAF Population

Additional Information

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Restriction type: OTHER