Trial Outcomes & Findings for Randomized Study to Evaluate MACE in Patients With Prostate Cancer Treated With Relugolix or Leuprolide Acetate (NCT NCT05605964)
NCT ID: NCT05605964
Last Updated: 2026-06-15
Results Overview
Number of patients with adverse events and serious adverse events
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
387 participants
Primary outcome timeframe
Screening; Day 1; 3, 6, 9, and 12 months; and every 3 months thereafter, up to 1 year
Results posted on
2026-06-15
Participant Flow
387 patients had enrolled into the trial, with 194 in the relugolix arm and 193 in the leuprolide acetate arm. Of those 387 patients, a total of 9 (3 relugolix; 6 leuprolide) never received study intervention.
Participant milestones
| Measure |
Relugolix
Oral relugolix 120 mg once daily with a loading dose of 360 mg on Day 1
|
Leuprolide Acetate
Subcutaneous or intramuscular leuprolide acetate 22.5 mg 3-M depot or 45 mg 6-M injection or Leuprolide acetate injectable emulsion (42 mg injectable emulsion is not allowed)
|
|---|---|---|
|
Overall Study
STARTED
|
191
|
187
|
|
Overall Study
COMPLETED
|
191
|
187
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Randomized Study to Evaluate MACE in Patients With Prostate Cancer Treated With Relugolix or Leuprolide Acetate
Baseline characteristics by cohort
| Measure |
Leuprolide Acetate
n=187 Participants
Subcutaneous or intramuscular leuprolide acetate 22.5 mg 3-M depot or 45 mg 6-M injection or Leuprolide acetate injectable emulsion (42 mg injectable emulsion is not allowed)
|
Total
n=378 Participants
Total of all reporting groups
|
Relugolix
n=191 Participants
Oral relugolix 120 mg once daily with a loading dose of 360 mg on Day 1
|
|---|---|---|---|
|
Age, Customized
Age · 65 years and younger
|
37 Participants
n=20 Participants
|
80 Participants
n=40 Participants
|
43 Participants
n=20 Participants
|
|
Age, Customized
Age · Above 65 years
|
150 Participants
n=20 Participants
|
298 Participants
n=40 Participants
|
148 Participants
n=20 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=20 Participants
|
0 Participants
n=40 Participants
|
0 Participants
n=20 Participants
|
|
Sex: Female, Male
Male
|
187 Participants
n=20 Participants
|
378 Participants
n=40 Participants
|
191 Participants
n=20 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=20 Participants
|
0 Participants
n=40 Participants
|
0 Participants
n=20 Participants
|
|
Race (NIH/OMB)
Asian
|
3 Participants
n=20 Participants
|
4 Participants
n=40 Participants
|
1 Participants
n=20 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=20 Participants
|
0 Participants
n=40 Participants
|
0 Participants
n=20 Participants
|
|
Race (NIH/OMB)
Black or African American
|
28 Participants
n=20 Participants
|
73 Participants
n=40 Participants
|
45 Participants
n=20 Participants
|
|
Race (NIH/OMB)
White
|
148 Participants
n=20 Participants
|
288 Participants
n=40 Participants
|
140 Participants
n=20 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=20 Participants
|
0 Participants
n=40 Participants
|
0 Participants
n=20 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
8 Participants
n=20 Participants
|
13 Participants
n=40 Participants
|
5 Participants
n=20 Participants
|
|
History of MACE
Yes
|
53 Participants
n=20 Participants
|
106 Participants
n=40 Participants
|
53 Participants
n=20 Participants
|
|
History of MACE
No
|
134 Participants
n=20 Participants
|
272 Participants
n=40 Participants
|
138 Participants
n=20 Participants
|
PRIMARY outcome
Timeframe: Screening; Day 1; 3, 6, 9, and 12 months; and every 3 months thereafter, up to 1 yearNumber of patients with adverse events and serious adverse events
Outcome measures
| Measure |
Relugolix
n=191 Participants
Oral relugolix 120 mg once daily with a loading dose of 360 mg on Day 1
|
Leuprolide Acetate
n=187 Participants
Subcutaneous or intramuscular leuprolide acetate 22.5 mg 3-M depot or 45 mg 6-M injection or Leuprolide acetate injectable emulsion (42 mg injectable emulsion is not allowed)
|
|---|---|---|
|
Number of Patients With Adverse Events and Serious Adverse Events
|
94 Participants
|
92 Participants
|
Adverse Events
Leuprolide Acetate
Serious events: 5 serious events
Other events: 91 other events
Deaths: 7 deaths
Relugolix
Serious events: 13 serious events
Other events: 93 other events
Deaths: 8 deaths
Serious adverse events
| Measure |
Leuprolide Acetate
n=187 participants at risk
Subcutaneous or intramuscular leuprolide acetate 22.5 mg 3-M depot or 45 mg 6-M injection or Leuprolide acetate injectable emulsion (42 mg injectable emulsion is not allowed)
|
Relugolix
n=191 participants at risk
Oral relugolix 120 mg once daily with a loading dose of 360 mg on Day 1
|
|---|---|---|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
0.00%
0/187 • From screening until end of follow-up, up to 1 year
|
0.52%
1/191 • From screening until end of follow-up, up to 1 year
|
|
Cardiac disorders
Atrial flutter
|
0.00%
0/187 • From screening until end of follow-up, up to 1 year
|
0.52%
1/191 • From screening until end of follow-up, up to 1 year
|
|
Cardiac disorders
Cardiac failure congestive
|
0.00%
0/187 • From screening until end of follow-up, up to 1 year
|
0.52%
1/191 • From screening until end of follow-up, up to 1 year
|
|
Cardiac disorders
Cardiac valve disease
|
0.00%
0/187 • From screening until end of follow-up, up to 1 year
|
0.52%
1/191 • From screening until end of follow-up, up to 1 year
|
|
Cardiac disorders
Cardiac arrest
|
0.53%
1/187 • From screening until end of follow-up, up to 1 year
|
0.00%
0/191 • From screening until end of follow-up, up to 1 year
|
|
Cardiac disorders
Cardio-respiratory arrest
|
0.53%
1/187 • From screening until end of follow-up, up to 1 year
|
0.00%
0/191 • From screening until end of follow-up, up to 1 year
|
|
Cardiac disorders
Left ventricular failure
|
0.53%
1/187 • From screening until end of follow-up, up to 1 year
|
0.00%
0/191 • From screening until end of follow-up, up to 1 year
|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/187 • From screening until end of follow-up, up to 1 year
|
1.0%
2/191 • From screening until end of follow-up, up to 1 year
|
|
Gastrointestinal disorders
Abdominal pain lower
|
0.00%
0/187 • From screening until end of follow-up, up to 1 year
|
0.52%
1/191 • From screening until end of follow-up, up to 1 year
|
|
Gastrointestinal disorders
Dysphagia
|
0.00%
0/187 • From screening until end of follow-up, up to 1 year
|
0.52%
1/191 • From screening until end of follow-up, up to 1 year
|
|
Infections and infestations
Urinary tract infection
|
0.00%
0/187 • From screening until end of follow-up, up to 1 year
|
1.0%
2/191 • From screening until end of follow-up, up to 1 year
|
|
Infections and infestations
Sepsis
|
0.53%
1/187 • From screening until end of follow-up, up to 1 year
|
0.52%
1/191 • From screening until end of follow-up, up to 1 year
|
|
Injury, poisoning and procedural complications
Fall
|
0.00%
0/187 • From screening until end of follow-up, up to 1 year
|
0.52%
1/191 • From screening until end of follow-up, up to 1 year
|
|
Metabolism and nutrition disorders
Dehydration
|
0.00%
0/187 • From screening until end of follow-up, up to 1 year
|
0.52%
1/191 • From screening until end of follow-up, up to 1 year
|
|
Nervous system disorders
Cerebrovascular accident
|
0.00%
0/187 • From screening until end of follow-up, up to 1 year
|
0.52%
1/191 • From screening until end of follow-up, up to 1 year
|
|
Nervous system disorders
Transient ischaemic attack
|
0.53%
1/187 • From screening until end of follow-up, up to 1 year
|
0.52%
1/191 • From screening until end of follow-up, up to 1 year
|
|
Renal and urinary disorders
Bladder spasm
|
0.00%
0/187 • From screening until end of follow-up, up to 1 year
|
0.52%
1/191 • From screening until end of follow-up, up to 1 year
|
|
Renal and urinary disorders
Haematuria
|
0.00%
0/187 • From screening until end of follow-up, up to 1 year
|
0.52%
1/191 • From screening until end of follow-up, up to 1 year
|
|
Respiratory, thoracic and mediastinal disorders
Acute respiratory failure
|
0.53%
1/187 • From screening until end of follow-up, up to 1 year
|
0.00%
0/191 • From screening until end of follow-up, up to 1 year
|
|
Surgical and medical procedures
Umbilical hernia repair
|
0.00%
0/187 • From screening until end of follow-up, up to 1 year
|
0.52%
1/191 • From screening until end of follow-up, up to 1 year
|
|
Vascular disorders
Internal haemorrhage
|
0.00%
0/187 • From screening until end of follow-up, up to 1 year
|
0.52%
1/191 • From screening until end of follow-up, up to 1 year
|
Other adverse events
| Measure |
Leuprolide Acetate
n=187 participants at risk
Subcutaneous or intramuscular leuprolide acetate 22.5 mg 3-M depot or 45 mg 6-M injection or Leuprolide acetate injectable emulsion (42 mg injectable emulsion is not allowed)
|
Relugolix
n=191 participants at risk
Oral relugolix 120 mg once daily with a loading dose of 360 mg on Day 1
|
|---|---|---|
|
Cardiac disorders
Myocardial infarction
|
2.1%
4/187 • From screening until end of follow-up, up to 1 year
|
2.6%
5/191 • From screening until end of follow-up, up to 1 year
|
|
Infections and infestations
Urinary tract infection
|
2.7%
5/187 • From screening until end of follow-up, up to 1 year
|
2.6%
5/191 • From screening until end of follow-up, up to 1 year
|
|
Renal and urinary disorders
Acute kidney injury
|
4.8%
9/187 • From screening until end of follow-up, up to 1 year
|
2.1%
4/191 • From screening until end of follow-up, up to 1 year
|
|
Metabolism and nutrition disorders
Dehydration
|
2.7%
5/187 • From screening until end of follow-up, up to 1 year
|
2.1%
4/191 • From screening until end of follow-up, up to 1 year
|
|
Psychiatric disorders
Depression
|
1.1%
2/187 • From screening until end of follow-up, up to 1 year
|
2.1%
4/191 • From screening until end of follow-up, up to 1 year
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.53%
1/187 • From screening until end of follow-up, up to 1 year
|
2.1%
4/191 • From screening until end of follow-up, up to 1 year
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
2.7%
5/187 • From screening until end of follow-up, up to 1 year
|
2.1%
4/191 • From screening until end of follow-up, up to 1 year
|
|
Vascular disorders
Hypertension
|
1.6%
3/187 • From screening until end of follow-up, up to 1 year
|
2.1%
4/191 • From screening until end of follow-up, up to 1 year
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
1.6%
3/187 • From screening until end of follow-up, up to 1 year
|
2.1%
4/191 • From screening until end of follow-up, up to 1 year
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
2.7%
5/187 • From screening until end of follow-up, up to 1 year
|
1.6%
3/191 • From screening until end of follow-up, up to 1 year
|
|
Infections and infestations
Pneumonia
|
3.2%
6/187 • From screening until end of follow-up, up to 1 year
|
1.6%
3/191 • From screening until end of follow-up, up to 1 year
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
2.1%
4/187 • From screening until end of follow-up, up to 1 year
|
1.0%
2/191 • From screening until end of follow-up, up to 1 year
|
|
Blood and lymphatic system disorders
Leukocytosis
|
2.1%
4/187 • From screening until end of follow-up, up to 1 year
|
0.00%
0/191 • From screening until end of follow-up, up to 1 year
|
|
Renal and urinary disorders
Urinary incontinence
|
2.1%
4/187 • From screening until end of follow-up, up to 1 year
|
0.00%
0/191 • From screening until end of follow-up, up to 1 year
|
|
Infections and infestations
Sepsis
|
2.1%
4/187 • From screening until end of follow-up, up to 1 year
|
1.6%
3/191 • From screening until end of follow-up, up to 1 year
|
|
Cardiac disorders
Atrial fibrillation
|
1.6%
3/187 • From screening until end of follow-up, up to 1 year
|
2.6%
5/191 • From screening until end of follow-up, up to 1 year
|
|
General disorders
Chest pain
|
3.7%
7/187 • From screening until end of follow-up, up to 1 year
|
2.6%
5/191 • From screening until end of follow-up, up to 1 year
|
|
Gastrointestinal disorders
Constipation
|
3.7%
7/187 • From screening until end of follow-up, up to 1 year
|
2.6%
5/191 • From screening until end of follow-up, up to 1 year
|
|
Injury, poisoning and procedural complications
Fall
|
3.2%
6/187 • From screening until end of follow-up, up to 1 year
|
2.6%
5/191 • From screening until end of follow-up, up to 1 year
|
|
Vascular disorders
Hot flush
|
8.0%
15/187 • From screening until end of follow-up, up to 1 year
|
11.5%
22/191 • From screening until end of follow-up, up to 1 year
|
|
Blood and lymphatic system disorders
Anaemia
|
4.8%
9/187 • From screening until end of follow-up, up to 1 year
|
7.9%
15/191 • From screening until end of follow-up, up to 1 year
|
|
General disorders
Fatigue
|
4.8%
9/187 • From screening until end of follow-up, up to 1 year
|
7.3%
14/191 • From screening until end of follow-up, up to 1 year
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.53%
1/187 • From screening until end of follow-up, up to 1 year
|
4.2%
8/191 • From screening until end of follow-up, up to 1 year
|
|
Nervous system disorders
Dizziness
|
2.1%
4/187 • From screening until end of follow-up, up to 1 year
|
4.2%
8/191 • From screening until end of follow-up, up to 1 year
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
2.7%
5/187 • From screening until end of follow-up, up to 1 year
|
4.2%
8/191 • From screening until end of follow-up, up to 1 year
|
|
Gastrointestinal disorders
Diarrhoea
|
1.6%
3/187 • From screening until end of follow-up, up to 1 year
|
3.7%
7/191 • From screening until end of follow-up, up to 1 year
|
|
Investigations
Weight increased
|
3.2%
6/187 • From screening until end of follow-up, up to 1 year
|
3.7%
7/191 • From screening until end of follow-up, up to 1 year
|
|
Respiratory, thoracic and mediastinal disorders
Acute respiratory failure
|
2.1%
4/187 • From screening until end of follow-up, up to 1 year
|
3.1%
6/191 • From screening until end of follow-up, up to 1 year
|
|
Infections and infestations
COVID-19
|
1.1%
2/187 • From screening until end of follow-up, up to 1 year
|
3.1%
6/191 • From screening until end of follow-up, up to 1 year
|
|
Nervous system disorders
Headache
|
1.1%
2/187 • From screening until end of follow-up, up to 1 year
|
3.1%
6/191 • From screening until end of follow-up, up to 1 year
|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/187 • From screening until end of follow-up, up to 1 year
|
2.6%
5/191 • From screening until end of follow-up, up to 1 year
|
|
General disorders
Asthenia
|
4.3%
8/187 • From screening until end of follow-up, up to 1 year
|
2.6%
5/191 • From screening until end of follow-up, up to 1 year
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee The results of this study may be published or presented at scientific meetings. If this is foreseen, the investigator agrees to submit all manuscripts or abstracts to the sponsor before submission. This allows the sponsor to protect proprietary information and to provide comments.
- Publication restrictions are in place
Restriction type: OTHER