Trial · NCT06462014
Description of Relugolix Use in Patients With Prostate Cancer Within the VHA
NCT06462014, Completed, Pfizer; results first posted 2025-12-11
3 sourcestrials-2026-11-12-0.5.0
Download JSON
Cite this record
ConductScience Library. Description of Relugolix Use in Patients With Prostate Cancer Within the VHA. Trials, record NCT06462014. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT06462014
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Description of Relugolix Use in Patients With Prostate Cancer Within the VHA
- NCT number
- NCT06462014
- Status
- Completed
- Enrollment
- 507 participants, actual
- Lead sponsor
- Pfizer
- Conditions
- Prostate Cancer
- Interventions
- Relugolix
- First posted
- 2024-06-17
- Last updated
- 2025-12-11
- Results first posted
- 2025-12-11
Source ClinicalTrials.gov
Registered outcomes11
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Number of Participants According to Geographic Region | Baseline period = Up to 1 year prior to index date; available data observed retrospectively over 178 days in this 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. |
| Primary | Number of Participants According to Index Year | At Index date (anytime between 18-Dec-2020 to 31-Dec- 2023 [approximately 3 years]; available data observed retrospectively over 178 days in this 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. |
| Primary | Time From First Observed Prostate Cancer Diagnosis Date to the Index Date | From prostate cancer diagnosis to index date (approximately maximum up to 18 years); available data observed retrospectively over 178 days in this 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. |
| Primary | Number of Participants According to Type of Previous Treatments Received | Baseline period = Up to 1 year prior to index date; available data observed retrospectively over 178 days in this study | 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. |
| Primary | Number of Participants According to Metastasis Status | 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 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. |
| Primary | Number of Participants According to Site of Metastasis | 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 study | 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. |
| Primary | Number of Participants According to Androgen Deprivation Therapy (ADT) Status | Any time prior to index date including baseline period (approximately maximum up to 18 years); available data observed retrospectively over 178 days in this study | 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. |
| Primary | Prostate-Specific Antigen (PSA) Value at 180 Days Prior to Index Date | 180 days prior to Index date; data observed retrospectively over 178 days in this study | 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. |
| Primary | Testosterone Value at 180 Days Prior to Index Date | 180 days prior to Index date; data observed retrospectively over 178 days in this study | 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. |
| Primary | Mean National Cancer Institute (NCI) Charlson Comorbidity Index (CCI) Score | 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 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. |
1 to 10 of 11Source ClinicalTrials.gov
See all 11 registered outcomesOutcomes11
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Number of Participants According to Geographic Region | Baseline period = Up to 1 year prior to index date; available data observed retrospectively over 178 days in this study | Analysis population included all eligible participants whose data was retrieved and observed in this retrospective observational study. | Participants | COUNT_OF_PARTICIPANTS |
| PRIMARY | Number of Participants According to Index Year | At Index date (anytime between 18-Dec-2020 to 31-Dec- 2023 [approximately 3 years]; available data observed retrospectively over 178 days in this study | Analysis population included all eligible participants whose data was retrieved and observed in this retrospective observational study. | Participants | COUNT_OF_PARTICIPANTS |
| PRIMARY | Time From First Observed Prostate Cancer Diagnosis Date to the Index Date | From prostate cancer diagnosis to index date (approximately maximum up to 18 years); available data observed retrospectively over 178 days in this study | Analysis population included all eligible participants whose data was retrieved and observed in this retrospective observational study. | Months | MEAN |
| PRIMARY | Number of Participants According to Type of Previous Treatments Received | Baseline period = Up to 1 year prior to index date; available data observed retrospectively over 178 days in this study | 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. | Participants | COUNT_OF_PARTICIPANTS |
| PRIMARY | Number of Participants According to Metastasis Status | 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 study | Analysis population included all eligible participants whose data was retrieved and observed in this retrospective observational study. | Participants | COUNT_OF_PARTICIPANTS |
| PRIMARY | Number of Participants According to Site of Metastasis | 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 study | 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. | Participants | COUNT_OF_PARTICIPANTS |
| PRIMARY | Number of Participants According to Androgen Deprivation Therapy (ADT) Status | Any time prior to index date including baseline period (approximately maximum up to 18 years); available data observed retrospectively over 178 days in this study | 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. | Participants | COUNT_OF_PARTICIPANTS |
| PRIMARY | Prostate-Specific Antigen (PSA) Value at 180 Days Prior to Index Date | 180 days prior to Index date; data observed retrospectively over 178 days in this study | 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. | Nanograms per milliliter | MEAN |
| PRIMARY | Testosterone Value at 180 Days Prior to Index Date | 180 days prior to Index date; data observed retrospectively over 178 days in this study | 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. | Nanograms per deciliter | MEAN |
| PRIMARY | Mean National Cancer Institute (NCI) Charlson Comorbidity Index (CCI) Score | 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 study | Analysis population included all eligible participants whose data was retrieved and observed in this retrospective observational study. | Units on a scale | MEAN |
1 to 10 of 11Source ClinicalTrials.gov
See all 11 outcomesResults by group50
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Number of Participants According to Geographic Region | Relugolix | South | 240 | Participants | |
| Number of Participants According to Geographic Region | Relugolix | West | 94 | Participants | |
| Number of Participants According to Geographic Region | Relugolix | Northeast | 93 | Participants | |
| Number of Participants According to Geographic Region | Relugolix | Midwest | 80 | Participants | |
| Number of Participants According to Index Year | Relugolix | 2020 | 0 | Participants | |
| Number of Participants According to Index Year | Relugolix | 2021 | 81 | Participants | |
| Number of Participants According to Index Year | Relugolix | 2022 | 203 | Participants | |
| Number of Participants According to Index Year | Relugolix | 2023 | 223 | Participants | |
| Time From First Observed Prostate Cancer Diagnosis Date to the Index Date | Relugolix | 55.8 | Standard Deviation 61.7 | Months | |
| Number of Participants According to Type of Previous Treatments Received | Relugolix | Pain medication | 103 | Participants |
1 to 10 of 50Source ClinicalTrials.gov
See all 50 results by groupParticipant flow3
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Relugolix | 507 | |
| Overall Study | COMPLETED | Relugolix | 507 | |
| Overall Study | NOT COMPLETED | Relugolix | 0 |
Source ClinicalTrials.gov
Adverse events0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
None in this release.
Adverse event totals3
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Relugolix | 38 | 507 |
| Total, other adverse events | Relugolix | 0 | 0 |
| Total, serious adverse events | Relugolix | 0 | 0 |
Source ClinicalTrials.gov
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 41174189 | DERIVED |
Source PubMed
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT06462014
GET https://conductscience.org/api/trials/v1/NCT06462014/results?page=2