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The aim of this study is to assess treatment patterns, characteristics, and clinical outcomes among adults with metastatic castration-resistant prostate cancer (mCRPC) who have previously received ≥1 androgen receptor pathway inhibitor (ARPI), ≥1 taxane, and 177Lu-PSMA-617 in the United States (US) real-world clinical practice. This study will be conducted using data extracted from the PRECISION (PRostatE Cancer dISease observatION) data platform.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Overall mCRPC Cohort | Adult patients with a diagnosis of mCRPC and evidence of prior treatment with ≥1 ARPI, ≥1 taxane, and 177Lu-PSMA-617 in PRECISION. | ||
| mCRPC Progression Subgroup | A subgroup of the Overall mCRPC Cohort. Patients with evidence of progression on or after 177Lu-PSMA-617 treatment. | ||
| ≥1 Subsequent Systemic Therapy Subgroup | A subgroup of the Overall mCRPC Cohort. Patients who initiate ≥1 post-index systemic therapy. |
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| Measure | Description | Time Frame |
|---|---|---|
| Number of Patients by Number of Lines of Therapy (LOTs) Between mCRPC Diagnosis and Index Date | The index date is the date of the last treatment administration of the latest of an ARPI, taxane, and 177Lu-PSMA-617. | Baseline |
| Number of Patients by Number and Type of Prior Therapies Indicated for Advanced Prostate Cancer (PC) | Number of patients by number and type of prior ARPI, taxane, 177Lu-PSMA-617, and other therapies indicated for advanced PC. | Baseline |
| Number of Patients by Number of Prostate-specific Membrane Antigen (PSMA) Scans | Baseline up to approximately 5 years | |
| Number of Patients by Timing of PSMA Scans | Timing of scans is categorized as pre-mCRPC diagnosis, post-mCRPC diagnosis but pre-index date, and post-index date. The index date is the date of the last treatment administration of the latest of an ARPI, taxane, and 177Lu-PSMA-617. | Baseline up to approximately 5 years |
| Number of Patients by Number of Post-index LOTs | Up to approximately 5 years | |
| Number of Patients by Type of Therapy at Each Post-index LOT | Up to approximately 5 years | |
| Time From Index Date to Next Therapy Initiation | The index date is the date of the last treatment administration of the latest of an ARPI, taxane, and 177Lu-PSMA-617. | Up to approximately 5 years |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Patients by Patient Characteristics | Patient characteristics include race, geographical region, insurance status, marital status, type of treatment center, comorbidities, Gleason score, disease stage at diagnosis, and prostate-specific antigen (PSA) level. | Baseline |
| Age |
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Inclusion criteria:
Exclusion criteria:
• None.
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Adult male patients with a diagnosis of mCRPC and evidence of prior treatment with ≥1 ARPI, ≥1 taxane, and 177Lu-PSMA-617 in the PRECISION data platform.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Novartis Pharmaceuticals | Contact | +41613241111 | novartis.email@novartis.com | |
| Novartis Pharmaceuticals | Contact |
| Name | Affiliation | Role |
|---|---|---|
| Novartis Pharmaceuticals | Novartis Pharmaceuticals | Study Director |
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| Baseline |
| Progression-free Survival (PFS) From Index Date | Time from the applicable index date until progression or death from any cause. The index date is the date of the last treatment administration of the latest of an ARPI, taxane, and 177Lu-PSMA-617. | Up to approximately 5 years |
| PFS From Initiation of First Post-index Therapy, in Patients With ≥1 Post-index Therapy | Time from the initiation of first post-index therapy until progression or death from any cause. | Up to approximately 5 years |
| Overall Survival (OS) From Index Date | Time from the applicable index date until death from any cause. The index date is the date of the last treatment administration of the latest of an ARPI, taxane, and 177Lu-PSMA-617. | Up to approximately 5 years |
| OS From Initiation of First Post-index Therapy, in Those With ≥1 Post-index Therapy | Time from initiation of first post-index therapy until death from any cause. | Up to approximately 5 years |
| Among Patients With ≥1 Post-index Therapy, Number of Patients With a Reduction in PSA Level | Reduction in PSA level categorized as follows:
| Up to approximately 5 years |
| Among Patients With ≥1 Post-index Therapy, Number of Patients With PSA <0.2 ng/mL on First Post-index Therapy | Up to approximately 5 years |
| ID | Term |
|---|---|
| D064129 | Prostatic Neoplasms, Castration-Resistant |
| ID | Term |
|---|---|
| D011471 | Prostatic Neoplasms |
| D005834 | Genital Neoplasms, Male |
| D014565 | Urogenital Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D005832 | Genital Diseases, Male |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D011469 | Prostatic Diseases |
| D052801 | Male Urogenital Diseases |
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