Prostate Cancer
Conditions
Keywords
Metastatic castrate-resistant prostate cancer, Treatment patterns, Treatment response, Overall survival
Brief summary
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.
Interventions
None listed
Sponsors
Novartis Pharmaceuticals
Study design
Observational model
COHORT
Time perspective
RETROSPECTIVE
Eligibility
Sex/Gender
MALE
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Phase I inclusion criteria: 1. Patients with ≥1 claim in the open-source medical claims data with a Healthcare Common Procedure Coding System (HCPCS) code of A9607 or ≥1 claim in the open-source medical or pharmacy claims data with a National Drug Code (NDC) code for 177Lu-PSMA-617 during the patient selection window. The date of the first such claim is the index date. 2. For patients identified via NDC code, ≥1 claim with one of the following procedure codes on the same date as the 177Lu-PSMA-617 NDC claim: HCPCS - A9699, J3590; CPT 79191; or ≥1 claim with HCPCS code A9595 or A9597 occurring within 14 days before or after the index date. 3. At least 18 years of age at index date. 4. Patients with ≥2 medical claims ≥180 days prior to the index date. For the treatment response analysis, the following additional criteria were applied: 5. Patients with linkage to lab data. 6. Patients with ≥1 PSA result available on or within 6 months prior to the index date. The PSA result closest to the index date was defined as the baseline PSA level. 7. Patients with ≥1 PSA result available after the index date. Phase II inclusion criteria: 1. ≥2 medical claims (≥30 days apart) with a diagnosis of prostate cancer observed during the patient selection period. 2. ≥1 medical claim with a diagnosis code for metastatic disease occurring on or after the first observed prostate cancer diagnosis. The date of the first such claim was defined as the date of metastasis. 3. Evidence of castration resistance observed during the study period. The date of mCRPC diagnosis was defined as the latest of the date of metastasis and the date of castration resistance and must have occurred during the index window. 4. ≥12 months of continuous data availability prior to the mCRPC diagnosis date. 5. ≥1 claim for 177Lu-PSMA-617 after mCRPC diagnosis and continuous data availability between diagnosis and the date of 177Lu-PSMA-617 initiation.
Exclusion criteria
1\. Standard data cleaning processes were applied to remove patients with data quality issues. Specific data quality issues included missing or invalid age or sex.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Patients by Demographic Category | Baseline | Demographics included: * Age group * Geographical region * Payer type * Physician specialty * Race/ethnicity * Education level * Occupation |
| Number of Patients by Clinical Characteristic Category | Baseline | 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) |
| Clinical Characteristic: Baseline PSA Level | Baseline | — |
| Overall Survival (OS) | Up to approximately 10 years | OS was defined as the time from mCRPC diagnosis until death. |
| Number of Patients who Died Within 6, 12, 24, and 36 Months From the mCRPC Diagnosis Date | 6, 12, 24, and 36 months | — |
| Survival Time After the Last Administration of 177Lu-PSMA-617 | Up to approximately 10 years | — |
| Number of Patients who Died After the Last Administration of 177Lu-PSMA-617 | Up to approximately 10 years | — |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Patients by Treatments Received From mCRPC Diagnosis to Initiation of 177Lu-PSMA-617 | Up to approximately 10 years | — |
| Percentage of Patients by Line of 177Lu-PSMA-617 Initiation | Up to approximately 10 years | — |
| Percentage of Patients by Sequence of Treatments Prior to 177Lu-PSMA-617 Treatment | Baseline | — |
| Duration of Each Line of Treatment (LOT) by Treatment Received | Up to approximately 10 years | — |
| Time From mCRPC Diagnosis to Initiation of 177Lu-PSMA-617 | Up to approximately 10 years | — |
| 177Lu-PSMA-617 Treatment Duration | 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 | 3, 6, 9, and 12 Months | — |
| Percentage of Patients by Number of 177Lu-PSMA-617 Cycles | Up to approximately 10 years | — |
| Time to Next Treatment (TTNT) | Up to approximately 10 years | TTNT was defined as time from the start of 177Lu-PSMA-617 therapy to the initiation of a new LOT. |
| Number of Patients With a Change in PSA Levels While on 177Lu-PSMA-617 by Percent Reduction in PSA | Up to approximately 2 years | Reduction in PSA was categorized as ≥50%, ≥80%, and ≥90%. |
Countries
United States
Contacts
STUDY_DIRECTORNovartis Pharmaceuticals
Novartis Pharmaceuticals
Outcome results
None listed