The aim of this study was to evaluate patient characteristics, treatment patterns, prostate-specific antigen (PSA) reduction, and overall survival (OS) of prostate cancer patients treated with 177-Lutetium-Prostate-Specific Membrane Antigen-617 (177Lu-PSMA-617). Patient data from multiple electronic health record databases, including claims (open-source medical and pharmacy claims), consumer attributes, mortality, and laboratory data linked to claims databases was used. The study analysis was conducted in two phases. Phase I provided an early view of patients treated with 177Lu-PSMA-617 shortly after launch. Phase II refreshed the data, added mortality and extracted additional years of historical data to allow for the identification of the initial metastatic castrate-resistant prostate cancer (mCRPC) diagnosis and follow-up from that date through the start of 177Lu-PSMA-617.
Study Type
OBSERVATIONAL
Enrollment
6,448
Novartis
East Hanover, New Jersey, United States
Number of Patients by Demographic Category
Demographics included: * Age group * Geographical region * Payer type * Physician specialty * Race/ethnicity * Education level * Occupation
Time frame: Baseline
Number of Patients by Clinical Characteristic Category
Clinical characteristics included: * National Cancer Institute (NCI) comorbidity index * NCI category * Comorbidities * Metastasis sites * Number of distinct metastatic sites * PSA level category (≤ 4 ng/ml, \> 4 ng/ml)
Time frame: Baseline
Clinical Characteristic: Baseline PSA Level
Time frame: Baseline
Overall Survival (OS)
OS was defined as the time from mCRPC diagnosis until death.
Time frame: Up to approximately 10 years
Number of Patients who Died Within 6, 12, 24, and 36 Months From the mCRPC Diagnosis Date
Time frame: 6, 12, 24, and 36 months
Survival Time After the Last Administration of 177Lu-PSMA-617
Time frame: Up to approximately 10 years
Number of Patients who Died After the Last Administration of 177Lu-PSMA-617
Time frame: Up to approximately 10 years
Percentage of Patients by Treatments Received From mCRPC Diagnosis to Initiation of 177Lu-PSMA-617
Time frame: Up to approximately 10 years
Percentage of Patients by Line of 177Lu-PSMA-617 Initiation
Time frame: Up to approximately 10 years
Percentage of Patients by Sequence of Treatments Prior to 177Lu-PSMA-617 Treatment
Time frame: Baseline
Duration of Each Line of Treatment (LOT) by Treatment Received
Time frame: Up to approximately 10 years
Time From mCRPC Diagnosis to Initiation of 177Lu-PSMA-617
Time frame: Up to approximately 10 years
177Lu-PSMA-617 Treatment Duration
Time frame: Up to approximately 10 years
Percentage of Patients Still on 177Lu-PSMA-617 Therapy at 3, 6, 9, and 12 Months After Initiation of 177Lu-PSMA-617
Time frame: 3, 6, 9, and 12 Months
Percentage of Patients by Number of 177Lu-PSMA-617 Cycles
Time frame: Up to approximately 10 years
Time to Next Treatment (TTNT)
TTNT was defined as time from the start of 177Lu-PSMA-617 therapy to the initiation of a new LOT.
Time frame: Up to approximately 10 years
Number of Patients With a Change in PSA Levels While on 177Lu-PSMA-617 by Percent Reduction in PSA
Reduction in PSA was categorized as ≥50%, ≥80%, and ≥90%.
Time frame: Up to approximately 2 years
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