Prostate Cancer
Conditions
Keywords
ORGOVYX, relugolix, prostate cancer, leuprolide acetate
Brief summary
This was a randomized study to evaluate the risk of major adverse cardiovascular events (MACE) for relugolix compared with leuprolide acetate. Enrollment in this study was discontinued by the Sponsor on 01 Dec 2023. In an effort to mitigate any treatment interruptions, actively enrolled patients will be allowed to remain on study drug up to a period of 12 months ending Dec 2024 if they choose to remain in the discontinuation phase of the study.
Detailed description
Eligible patients were randomized (1:1) to receive either relugolix or leuprolide acetate for prostate cancer or as an adjunct to primary or salvage radiation therapy. The study was intended to collect clinical and cardiovascular risk factor data on patients ages 18 and older who were receiving relugolix or leuprolide acetate for their prostate cancer or as adjunct to radiation therapy with a treatment plan to be on at least 12 months of continuous ADT. Enrollment in this study was discontinued by the Sponsor on 04 Dec 2023. In an effort to mitigate any treatment interruptions, actively enrolled patients will be allowed to remain on study drug up to a period of 12 months ending Dec 2024. During this discontinuation phase, all active investigative sites will be expected to formulate a transition plan for their study patients from this clinical study to SOC as soon as practicable. The primary endpoint in this study was the time to first adjudicated MACE (nonfatal myocardial infarction, nonfatal stroke, and cardiovascular death). However, with the discontinuation of enrollment in the study on 04 DEC 2023 by the sponsor, the primary endpoint will be to describe the safety of relugolix in the study population while actively enrolled patients remain on study drug.
Interventions
DRUGRelugolix
Relugolix tablet
DRUGLeuprolide Acetate
Leuprolide acetate injection
Sponsors
Sumitomo Pharma America, Inc.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
MALE
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
A patient will be eligible for inclusion in the discontinuation phase of the study if the following applies: 1. Was previously enrolled under the original version and amendment 1 of this study 2. Has voluntarily resigned and dated the informed consent form prior to transition to the discontinuation phase of this study
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Patients With Adverse Events and Serious Adverse Events | Screening; Day 1; 3, 6, 9, and 12 months; and every 3 months thereafter, up to 1 year | Number of patients with adverse events and serious adverse events |
Countries
United States
Participant flow
Pre-assignment details
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.
Baseline characteristics
| Characteristic | — |
|---|---|
| Age, Customized Age 65 years and younger | 80 Participants |
| Age, Customized Age Above 65 years | 150 Participants |
| History of MACE No | 134 Participants |
| History of MACE Yes | 53 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 4 Participants |
| Race (NIH/OMB) Black or African American | 45 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 | 13 Participants |
| Race (NIH/OMB) White | 148 Participants |
| Sex: Female, Male Female | 0 Participants |
| Sex: Female, Male Male | 187 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 8 / 191 | 7 / 187 |
| other Total, other adverse events | 93 / 191 | 91 / 187 |
| serious Total, serious adverse events | 13 / 191 | 5 / 187 |
Outcome results
None listed