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The aim of this study was to assess the characteristics, treatment patterns, and clinical outcomes among metastatic castration-resistant prostate cancer (mCRPC) patients in the United States (US) who were treated with lutetium-177 vipivotide tetraxetan (177Lu-PSMA-617) in the real-world setting.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Overall 177Lu-PSMA-617 Cohort | All patients treated with 177Lu-PSMA-617. | ||
| Prior Treatment Use Cohort: ≥1 Androgen Receptor Pathway Inhibitor (ARPI) and ≥1 Taxane | Patients treated with 177Lu-PSMA-617 after at least 1 ARPI and at least 1 taxane treatment. ARPIs include abiraterone, enzalutamide, darolutamide, and apalutamide. Taxanes include cabazitaxel and docetaxel. | ||
| Prior Treatment Use Cohort: 1 ARPI and 1 Taxane | Patients treated with 177Lu-PSMA-617 after 1 ARPI and 1 taxane treatment. ARPIs include abiraterone, enzalutamide, darolutamide, and apalutamide. Taxanes include cabazitaxel and docetaxel. | ||
| Prior Treatment Use Cohort: Delayed | Patients with evidence of 1 ARPI and 1 taxane treatment plus at least 1 additional ARPI or taxane before 177Lu-PSMA-617 initiation. ARPIs include abiraterone, enzalutamide, darolutamide, and apalutamide. Taxanes include cabazitaxel and docetaxel. | ||
| Subsequent Treatment Use Cohort: Any Guideline-Recommended Treatment | Patients treated with any guideline-recommended treatment for mCRPC after 177Lu-PSMA-617 discontinuation. Guideline-recommended treatments include abiraterone, enzalutamide, darolutamide, apalutamide, cabazitaxel, docetaxel, pembrolizumab, sipuleucel-T, niraparib, olaparib, talazoparib, rucaparib, radium-223; carboplatin, cisplatin, etoposide, and mitoxantrone. |
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| Measure | Description | Time Frame |
|---|---|---|
| Number of Patients by Patient Characteristic | Patient characteristics included:
| Baseline |
| Mean PSA Level | Baseline | |
| Number of Patients by Number of ARPIs and Taxanes Received Before 177Lu-PSMA-617 Treatment Initiation | Baseline | |
| Number of Patients by Number of Doses of 177Lu-PSMA-617 Treatment From Initiation Until Discontinuation | Up to approximately 2 years | |
| Duration of 177Lu-PSMA-617 Treatment | Up to approximately 2 years | |
| Number and Percentage of Patients Initiating ARPIs, Taxanes, and Other Guideline-recommended Therapies for mCRPC After 177Lu-PSMA-617 Discontinuation | Up to approximately 2 years |
| Measure | Description | Time Frame |
|---|---|---|
| Number and Percentage of Patients With a Reduction in PSA Level | Reduction in PSA level was categorized as follows:
| Baseline up to approximately 2 years |
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Inclusion criteria:
Exclusion criteria:
• None
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All adult patients with evidence of treatment with 177Lu-PSMA-617.
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| Name | Affiliation | Role |
|---|---|---|
| Novartis Pharmaceuticals | Novartis Pharmaceuticals | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Novartis | East Hanover | New Jersey | 07936 | United States |
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| Label | URL |
|---|---|
| Link to study results | View source |
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| ID | Term |
|---|---|
| D011471 | Prostatic Neoplasms |
| ID | Term |
|---|---|
| D005834 | Genital Neoplasms, Male |
| D014565 | Urogenital Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
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| Subsequent Treatment Use Cohort: ARPI/Taxane | Patients treated with any ARPI or taxane after 177Lu-PSMA-617 discontinuation (i.e., abiraterone, enzalutamide, darolutamide, apalutamide, cabazitaxel, docetaxel). |
| Subsequent Treatment Use Cohort: ARPI | Patients treated with any ARPI after 177Lu-PSMA-617 discontinuation (i.e., abiraterone, enzalutamide, darolutamide, apalutamide). |
| Subsequent Treatment Use Cohort: Taxane | Patients treated with any taxane after 177Lu-PSMA-617 discontinuation (i.e., cabazitaxel, docetaxel). |
| D005832 |
| Genital Diseases, Male |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D011469 | Prostatic Diseases |
| D052801 | Male Urogenital Diseases |