Trial Outcomes & Findings for Description of Relugolix Use in Patients With Prostate Cancer Within the VHA (NCT NCT06462014)
NCT ID: NCT06462014
Last Updated: 2025-12-11
Results Overview
The number of participants according to geographic regions of the United States (South, West, Northeast and Midwest) as documented during baseline period were reported in this outcome measure. Baseline period was 1 year prior to index date; index date was the initiation date of relugolix (anytime between 18-Dec-2020 to 31-Dec-2023) on or after the first observed prostate cancer diagnosis.
COMPLETED
507 participants
Baseline period = Up to 1 year prior to index date; available data observed retrospectively over 178 days in this study
2025-12-11
Participant Flow
Data from participants with a diagnosis of prostate cancer between 01-Jan-2006 to 31-Dec-2023 and who had initiated relugolix anytime between 18-Dec-2020 (approval date for relugolix in the United States) to 31-Dec-2023 was included. Data was collected from the National Veterans Affairs (VA) Health Care Network database. Available retrospective data was evaluated over 178 days (from 19-Jun-2024 to 13-Dec-2024) in this observational study per its objective.
Participant milestones
| Measure |
Relugolix
Participants who were diagnosed with prostate cancer and had initiated relugolix between 18-Dec-2020 to 31-Dec-2023 were observed. No intervention was administered in this study.
|
|---|---|
|
Overall Study
STARTED
|
507
|
|
Overall Study
COMPLETED
|
507
|
|
Overall Study
NOT COMPLETED
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Description of Relugolix Use in Patients With Prostate Cancer Within the VHA
Baseline characteristics by cohort
| Measure |
Relugolix
n=507 Participants
Participants who were diagnosed with prostate cancer and had initiated relugolix between 18-Dec-2020 to 31-Dec-2023 were observed. No intervention was administered in this study.
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|---|---|
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Age, Continuous
|
74.2 Years
STANDARD_DEVIATION 7.9 • n=237 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=237 Participants
|
|
Sex: Female, Male
Male
|
507 Participants
n=237 Participants
|
|
Race/Ethnicity, Customized
White, non-Hispanic
|
313 Participants
n=237 Participants
|
|
Race/Ethnicity, Customized
Black
|
141 Participants
n=237 Participants
|
|
Race/Ethnicity, Customized
Hispanic
|
16 Participants
n=237 Participants
|
|
Race/Ethnicity, Customized
Other
|
6 Participants
n=237 Participants
|
|
Race/Ethnicity, Customized
Unknown
|
31 Participants
n=237 Participants
|
PRIMARY outcome
Timeframe: Baseline period = Up to 1 year prior to index date; available data observed retrospectively over 178 days in this studyPopulation: Analysis population included all eligible participants whose data was retrieved and observed in this retrospective observational study.
The number of participants according to geographic regions of the United States (South, West, Northeast and Midwest) as documented during baseline period were reported in this outcome measure. Baseline period was 1 year prior to index date; index date was the initiation date of relugolix (anytime between 18-Dec-2020 to 31-Dec-2023) on or after the first observed prostate cancer diagnosis.
Outcome measures
| Measure |
Relugolix
n=507 Participants
Participants who were diagnosed with prostate cancer and had initiated relugolix between 18-Dec-2020 to 31-Dec-2023 were observed. No intervention was administered in this study.
|
|---|---|
|
Number of Participants According to Geographic Region
South
|
240 Participants
|
|
Number of Participants According to Geographic Region
West
|
94 Participants
|
|
Number of Participants According to Geographic Region
Northeast
|
93 Participants
|
|
Number of Participants According to Geographic Region
Midwest
|
80 Participants
|
PRIMARY outcome
Timeframe: At Index date (anytime between 18-Dec-2020 to 31-Dec- 2023 [approximately 3 years]; available data observed retrospectively over 178 days in this studyPopulation: Analysis population included all eligible participants whose data was retrieved and observed in this retrospective observational study.
Number of participants according to index year (2020, 2021, 2022 and 2023) were reported in this outcome measure. The index date was defined as the initiation date of relugolix (anytime between 18-Dec-2020 to 31-Dec-2023) on or after the first observed prostate cancer diagnosis.
Outcome measures
| Measure |
Relugolix
n=507 Participants
Participants who were diagnosed with prostate cancer and had initiated relugolix between 18-Dec-2020 to 31-Dec-2023 were observed. No intervention was administered in this study.
|
|---|---|
|
Number of Participants According to Index Year
2020
|
0 Participants
|
|
Number of Participants According to Index Year
2021
|
81 Participants
|
|
Number of Participants According to Index Year
2022
|
203 Participants
|
|
Number of Participants According to Index Year
2023
|
223 Participants
|
PRIMARY outcome
Timeframe: From prostate cancer diagnosis to index date (approximately maximum up to 18 years); available data observed retrospectively over 178 days in this studyPopulation: Analysis population included all eligible participants whose data was retrieved and observed in this retrospective observational study.
Time from the first observed prostate cancer date to the index date was evaluated. All data available prior to the index date were used. The index date was defined as the initiation date of relugolix (anytime between 18-Dec-2020 to 31-Dec-2023) on or after the first observed prostate cancer diagnosis. Participants with a diagnosis of prostate cancer between 01-Jan-2006 to 31-Dec-2023 were considered.
Outcome measures
| Measure |
Relugolix
n=507 Participants
Participants who were diagnosed with prostate cancer and had initiated relugolix between 18-Dec-2020 to 31-Dec-2023 were observed. No intervention was administered in this study.
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|---|---|
|
Time From First Observed Prostate Cancer Diagnosis Date to the Index Date
|
55.8 Months
Standard Deviation 61.7
|
PRIMARY outcome
Timeframe: Baseline period = Up to 1 year prior to index date; available data observed retrospectively over 178 days in this studyPopulation: Analysis population included all eligible participants whose data was retrieved and observed in this retrospective observational study. All the participants of the study were analyzed but not all participants might have contributed to the data reported.
Number of participants according to treatments received previously such as pain medication, androgen receptor pathway inhibitor, androgen deprivation therapy, chronic oral corticosteroid use, non-steroidal anti-androgen, radiotherapy, olaparib, prostatectomy and chemotherapy in the baseline period were reported in this outcome measure. Baseline period was 1 year prior to index date; index date was the initiation date of relugolix (anytime between 18-Dec-2020 to 31-Dec-2023) on or after the first observed prostate cancer diagnosis. One participant could have received more than 1 treatment.
Outcome measures
| Measure |
Relugolix
n=507 Participants
Participants who were diagnosed with prostate cancer and had initiated relugolix between 18-Dec-2020 to 31-Dec-2023 were observed. No intervention was administered in this study.
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|---|---|
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Number of Participants According to Type of Previous Treatments Received
Pain medication
|
103 Participants
|
|
Number of Participants According to Type of Previous Treatments Received
Androgen receptor pathway inhibitor
|
86 Participants
|
|
Number of Participants According to Type of Previous Treatments Received
Androgen deprivation therapy
|
77 Participants
|
|
Number of Participants According to Type of Previous Treatments Received
Chronic oral corticosteroid use
|
48 Participants
|
|
Number of Participants According to Type of Previous Treatments Received
Non-steroidal anti-androgen
|
46 Participants
|
|
Number of Participants According to Type of Previous Treatments Received
Radiotherapy
|
7 Participants
|
|
Number of Participants According to Type of Previous Treatments Received
Olaparib
|
3 Participants
|
|
Number of Participants According to Type of Previous Treatments Received
Prostatectomy
|
3 Participants
|
|
Number of Participants According to Type of Previous Treatments Received
Chemotherapy
|
2 Participants
|
PRIMARY outcome
Timeframe: Baseline period = Up to 1 year prior to index date or within 90 days after the index date; available data observed retrospectively over 178 days in this studyPopulation: Analysis population included all eligible participants whose data was retrieved and observed in this retrospective observational study.
Number of participants according to metastasis status (metastatic prostate cancer and non-metastatic prostate cancer) were reported in this outcome measure. Metastatic prostate cancer was defined as having evidence of during the baseline period or within 90 days after the index date. Baseline period was 1 year prior to index date; index date was the initiation date of relugolix (anytime between 18-Dec-2020 to 31-Dec-2023) on or after the first observed prostate cancer diagnosis.
Outcome measures
| Measure |
Relugolix
n=507 Participants
Participants who were diagnosed with prostate cancer and had initiated relugolix between 18-Dec-2020 to 31-Dec-2023 were observed. No intervention was administered in this study.
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|---|---|
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Number of Participants According to Metastasis Status
Metastatic prostate cancer
|
169 Participants
|
|
Number of Participants According to Metastasis Status
Non-metastatic prostate cancer
|
338 Participants
|
PRIMARY outcome
Timeframe: Baseline period = Up to 1 year prior to index date or within 90 days after the index date; available data observed retrospectively over 178 days in this studyPopulation: Analysis population included all eligible participants whose data was retrieved and observed in this retrospective observational study. Here, "Overall Number of Participants Analyzed" signifies number of participants evaluable for this outcome measure.
Number of participants with a metastatic diagnosis at the sites: bone only, node only, bone and node, viscera and other (urinary organs, genital organs, skin, kidney, adrenal, brain, spinal, and other nervous system), were reported among participants with metastatic prostate cancer. Metastatic prostate cancer was defined as having evidence of metastasis any time prior to the index date or within 90 days after the index date. Baseline period was 1 year prior to index date; index date was the initiation date of relugolix (anytime between 18-Dec-2020 to 31-Dec-2023) on or after the first observed prostate cancer diagnosis.
Outcome measures
| Measure |
Relugolix
n=169 Participants
Participants who were diagnosed with prostate cancer and had initiated relugolix between 18-Dec-2020 to 31-Dec-2023 were observed. No intervention was administered in this study.
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|---|---|
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Number of Participants According to Site of Metastasis
Bone only
|
59 Participants
|
|
Number of Participants According to Site of Metastasis
Node only
|
34 Participants
|
|
Number of Participants According to Site of Metastasis
Bone and Node
|
20 Participants
|
|
Number of Participants According to Site of Metastasis
Viscera
|
20 Participants
|
|
Number of Participants According to Site of Metastasis
Other
|
36 Participants
|
PRIMARY outcome
Timeframe: Any time prior to index date including baseline period (approximately maximum up to 18 years); available data observed retrospectively over 178 days in this studyPopulation: Analysis population included all eligible participants whose data was retrieved and observed in this retrospective observational study. Here, "Number Analyzed" signifies number of participants evaluable for the specified rows.
ADT naïve was defined as having no records of any systemic ADT ever based on all available data prior to the index date (i.e., including baseline period data and any available data prior to the baseline period). Systemic ADT included luteinizing hormone-releasing hormone (LHRH) agonists and gonadotropin-releasing hormone (GnRH) antagonists (i.e., degarelix, relugolix, goserelin, histrelin, leuprolide, triptorelin). ADT experienced was defined as having any records of systemic ADT based on all available data prior to the index date (i.e., including baseline period data and any available data prior to the baseline period). Baseline period was 1 year prior to index date; index date was the initiation date of relugolix (anytime between 18-Dec-2020 to 31-Dec-2023) on or after the first observed prostate cancer diagnosis.
Outcome measures
| Measure |
Relugolix
n=507 Participants
Participants who were diagnosed with prostate cancer and had initiated relugolix between 18-Dec-2020 to 31-Dec-2023 were observed. No intervention was administered in this study.
|
|---|---|
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Number of Participants According to Androgen Deprivation Therapy (ADT) Status
Metastatic PC · ADT naïve
|
80 Participants
|
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Number of Participants According to Androgen Deprivation Therapy (ADT) Status
Metastatic PC · ADT experienced
|
89 Participants
|
|
Number of Participants According to Androgen Deprivation Therapy (ADT) Status
No known metastases · ADT naïve
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286 Participants
|
|
Number of Participants According to Androgen Deprivation Therapy (ADT) Status
No known metastases · ADT experienced
|
52 Participants
|
PRIMARY outcome
Timeframe: 180 days prior to Index date; data observed retrospectively over 178 days in this studyPopulation: Analysis population included all eligible participants whose data was retrieved and observed in this retrospective observational study. Here, 'Overall Number of Participants Analyzed' signifies number of participants evaluable for this outcome measure.
The index date was defined as the initiation date of relugolix (anytime between 18-Dec-2020 to 31-Dec-2023) on or after the first observed PC diagnosis.
Outcome measures
| Measure |
Relugolix
n=313 Participants
Participants who were diagnosed with prostate cancer and had initiated relugolix between 18-Dec-2020 to 31-Dec-2023 were observed. No intervention was administered in this study.
|
|---|---|
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Prostate-Specific Antigen (PSA) Value at 180 Days Prior to Index Date
|
118.8 Nanograms per milliliter
Standard Deviation 1080.6
|
PRIMARY outcome
Timeframe: 180 days prior to Index date; data observed retrospectively over 178 days in this studyPopulation: Analysis population included all eligible participants whose data was retrieved and observed in this retrospective observational study. Here, 'Overall Number of Participants Analyzed' signifies number of participants evaluable for this outcome measure.
The index date was defined as the initiation date of relugolix (anytime between 18-Dec-2020 to 31-Dec-2023) on or after the first observed PC diagnosis.
Outcome measures
| Measure |
Relugolix
n=109 Participants
Participants who were diagnosed with prostate cancer and had initiated relugolix between 18-Dec-2020 to 31-Dec-2023 were observed. No intervention was administered in this study.
|
|---|---|
|
Testosterone Value at 180 Days Prior to Index Date
|
200.9 Nanograms per deciliter
Standard Deviation 213.1
|
PRIMARY outcome
Timeframe: Baseline period = Up to 1 year prior to index date or within 90 days after the index date; available data observed retrospectively over 178 days in this studyPopulation: Analysis population included all eligible participants whose data was retrieved and observed in this retrospective observational study.
CCI based on various comorbid conditions such as myocardial infarction, congestive heart failure, peripheral vascular disease, cerebrovascular disease, dementia, chronic obstructive pulmonary disease, rheumatologic disease, peptic ulcer disease, mild liver disease, diabetes (mild to moderate), diabetes + complications, hemiplegia or paraplegia, renal disease, any malignancy (lymphoma and leukemia), moderate/severe liver disease, metastatic solid tumor, and acquired immune deficiency syndrome (AIDS) were reported. CCI score range was from 0 to 14, where "0"= low comorbid condition and "14"= high comorbid condition, higher scores indicated more comorbidity. Baseline period was 1 year prior to index date; index date was the initiation date of relugolix (anytime between 18-Dec-2020 to 31-Dec-2023) on or after the first observed prostate cancer diagnosis.
Outcome measures
| Measure |
Relugolix
n=507 Participants
Participants who were diagnosed with prostate cancer and had initiated relugolix between 18-Dec-2020 to 31-Dec-2023 were observed. No intervention was administered in this study.
|
|---|---|
|
Mean National Cancer Institute (NCI) Charlson Comorbidity Index (CCI) Score
|
1.8 Units on a scale
Standard Deviation 2.1
|
PRIMARY outcome
Timeframe: Baseline period = Up to 1 year prior to index date or within 90 days after the index date; available data observed retrospectively over 178 days in this studyPopulation: Analysis population included all eligible participants whose data was retrieved and observed in this retrospective observational study.
Number of participants according to comorbidities (hypertension, hyperlipidemia, diabetes, major adverse cardiovascular event, depression, congestive heart failure, sexual dysfunction, chronic obstructive pulmonary disease, anxiety, cognitive impairment, urinary tract infection, myocardial infarction, arrhythmia, stroke, acute coronary syndrome, angina pectoris, inflammatory bowel disease, hot flashes) were reported in this outcome measure. Baseline period was 1 year prior to index date; index date was the initiation date of relugolix (anytime between 18-Dec-2020 to 31-Dec-2023) on or after the first observed prostate cancer diagnosis. One participant could have more than one comorbidity.
Outcome measures
| Measure |
Relugolix
n=507 Participants
Participants who were diagnosed with prostate cancer and had initiated relugolix between 18-Dec-2020 to 31-Dec-2023 were observed. No intervention was administered in this study.
|
|---|---|
|
Number of Participants According to Comorbidities
Hypertension
|
357 Participants
|
|
Number of Participants According to Comorbidities
Hyperlipidemia
|
319 Participants
|
|
Number of Participants According to Comorbidities
Diabetes
|
168 Participants
|
|
Number of Participants According to Comorbidities
Major adverse cardiovascular event
|
114 Participants
|
|
Number of Participants According to Comorbidities
Depression
|
90 Participants
|
|
Number of Participants According to Comorbidities
Congestive heart failure
|
74 Participants
|
|
Number of Participants According to Comorbidities
Sexual dysfunction
|
74 Participants
|
|
Number of Participants According to Comorbidities
Chronic obstructive pulmonary disease
|
68 Participants
|
|
Number of Participants According to Comorbidities
Anxiety
|
57 Participants
|
|
Number of Participants According to Comorbidities
Cognitive impairment
|
57 Participants
|
|
Number of Participants According to Comorbidities
Urinary tract infection
|
52 Participants
|
|
Number of Participants According to Comorbidities
Myocardial infarction
|
31 Participants
|
|
Number of Participants According to Comorbidities
Arrhythmia
|
28 Participants
|
|
Number of Participants According to Comorbidities
Stroke
|
26 Participants
|
|
Number of Participants According to Comorbidities
Acute coronary syndrome
|
15 Participants
|
|
Number of Participants According to Comorbidities
Angina pectoris
|
11 Participants
|
|
Number of Participants According to Comorbidities
Inflammatory bowel disease
|
6 Participants
|
|
Number of Participants According to Comorbidities
Hot flashes
|
2 Participants
|
Adverse Events
Relugolix
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee Pfizer has the right to review disclosures, requesting a delay of less than 60 days. Investigator will postpone single center publications until after disclosure of pooled data (all sites), less than 12 months from study completion/termination at all participating sites. Investigator may not disclose previously undisclosed confidential information other than study results.
- Publication restrictions are in place
Restriction type: OTHER