The purpose of this real-world study is the learn about the demographics and clinical characteristics of patients with prostate cancer who initiated relugolix
Prostate cancer (PC) is the most common cancer and the second leading cause of cancer death among men in the United States. Androgen deprivation therapy (ADT) such as injectable luteinizing hormone-releasing hormone (LHRH) agonists (e.g., leuprolide) is the standard of care for PC patients. ADT treatment can suppress testosterone level to castrate level and delay the progression of the disease. Relugolix is a recently approved oral GnRH antagonist. While the introduction of relugolix has offered a unique opportunity for patients with PC, it's vital to understand how it is being used in real-world.
Study Type
OBSERVATIONAL
Enrollment
507
relugolix
Pfizer
New York, New York, United States
Number of Participants According to Geographic Region
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.
Time frame: 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 Index Year
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.
Time frame: 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
Time From First Observed Prostate Cancer Diagnosis Date to the Index Date
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.
Time frame: From prostate cancer diagnosis to index date (approximately maximum up to 18 years); available data observed retrospectively over 178 days in this study
Number of Participants According to Type of Previous Treatments Received
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.
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Time frame: 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 Metastasis Status
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.
Time frame: 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 Site of Metastasis
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.
Time frame: 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 Androgen Deprivation Therapy (ADT) Status
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.
Time frame: 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
Prostate-Specific Antigen (PSA) Value at 180 Days Prior to Index Date
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.
Time frame: 180 days prior to Index date; data observed retrospectively over 178 days in this study
Testosterone Value at 180 Days Prior to Index Date
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.
Time frame: 180 days prior to Index date; data observed retrospectively over 178 days in this study
Mean National Cancer Institute (NCI) Charlson Comorbidity Index (CCI) Score
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.
Time frame: 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 Comorbidities
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.
Time frame: 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