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This study aims to evaluate the various aspects of treatment effectiveness of [177Lu]Lu-PSMA-617 (Pluvicto) in mCRPC patients in both pre- and post-taxane settings. The study will be conducted using real-world data sources from the United States (US) and Germany.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Overall mCRPC Cohort | Adult male mCRPC patients who have received at least one dose of [177Lu]Lu-PSMA-617. | ||
| Chemo-naive mCRPC Cohort | A sub-group of the Overall mCRPC Cohort. Adult male mCRPC patients who have received at least one dose of [177Lu]Lu-PSMA-617 and have not received chemotherapy in the mCRPC stage. | ||
| Post-taxane mCRPC Cohort | A sub-group of the Overall mCRPC Cohort. Adult male mCRPC patients who have received at least one dose of [177Lu]Lu-PSMA-617 after taxane-based chemotherapy in the mCRPC stage. |
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| Measure | Description | Time Frame |
|---|---|---|
| Real-World Overall Survival (rwOS) | rwOS, defined as the time from index date, i.e., date of [177Lu]Lu-PSMA-617 administration, until death due to any cause. | Up to approximately 3 years |
| Median rwOS | Median rwOS, defined as the time from the index date, i.e., date of [177Lu]Lu-PSMA-617 administration, to when half of the patients in the cohort are still alive. | Up to approximately 3 years |
| Measure | Description | Time Frame |
|---|---|---|
| Baseline Demographics | Baseline | |
| Proportion of Patients by Clinical Characteristic | Clinical characteristics (based on data availability):
|
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Inclusion criteria:
Exclusion criteria:
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Adult male patients with mCRPC in the US and Germany, who received [177Lu]Lu-PSMA-617.
| 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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| ID | Term |
|---|---|
| D064129 | Prostatic Neoplasms, Castration-Resistant |
| D009362 | Neoplasm Metastasis |
| ID | Term |
|---|---|
| D011471 | Prostatic Neoplasms |
| D005834 | Genital Neoplasms, Male |
| D014565 | Urogenital Neoplasms |
| D009371 | Neoplasms by Site |
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| Baseline |
| Proportion of Patients by Clinical Characteristic: Eastern Cooperative Oncology Group (ECOG) Performance Status | ECOG performance status is a scale used to measure a patient's level of functioning in terms of self-care, daily activity, and physical ability. Scores range from 0 (fully active, able to carry out all pre-disease performance without restriction) to 5 (deceased). | Baseline |
| Proportion of Patients by Clinical Characteristic: Karnofsky Performance Status | The Karnofsky performance status scale is an assessment scale used to measure an individual's functional status and ability to perform daily activities. The Karnofsky performance scale uses an 11-point scale in 10-point increments ranging from 100 (normal functioning) to 0 (deceased). | Baseline |
| Duration Between Metastatic PC Diagnosis and mCRPC Diagnosis | Baseline |
| Prostate Specific Antigen (PSA) Level | Baseline |
| Testosterone Level | Baseline |
| Lactate Dehydrogenase (LDH) Level | Baseline |
| Alkaline Phosphatase (ALP) Level | Baseline |
| Real-World Progression Free Survival (rwPFS) | rwPFS, defined as the time from the index date to the date of first documented progression, or next treatment initiation, or death from any cause, whichever occurs first. | Up to approximately 3 years |
| Median rwPFS | Median rwPFS, defined as the time from the index date to when half of the patients in the cohort have disease progression or death. | Up to approximately 3 years |
| Duration Between mCRPC Diagnosis and [177Lu]Lu-PSMA-617 Treatment Initiation | Baseline |
| Number of Patients by Number of [177Lu]Lu-PSMA-617 Cycles Received | Up to approximately 3 years |
| Time Interval Between Two Consecutive [177Lu]Lu-PSMA-617 Cycles | Up to approximately 3 years |
| Proportion of Patients With a Dose Modification | Dose modification is defined as any change (reduction/escalation) in dose or frequency relative to the recommended dose in label. | Up to approximately 3 years |
| Time-to-First Dose Modification | Dose modification is defined as any change (reduction/escalation) in dose or frequency relative to the recommended dose in label. | Up to approximately 3 years |
| Proportion of Patients who Discontinue Treatment | Up to approximately 3 years |
| Proportion of Patients who Switch Treatment | Proportion of patients who discontinue [177Lu]Lu-PSMA-617 treatment and initiate new drug(s). | Up to approximately 3 years |
| Time-to-Treatment Discontinuation (TTD1L) | Up to approximately 3 years |
| Time-to-Next Treatment (TTNT) | Time from initiation of [177Lu]Lu-PSMA-617 until the start date of the next treatment or death, whichever occurs first. | Up to approximately 3 years |
| Proportion of Patients With Adverse Events | Up to 42 days after the last dose of [177Lu]Lu-PSMA-617 |
| Proportion of Patients With Safety Topics of Interest (STIs) | STIs: renal events, myelosuppression (cytopenias, bone marrow failure), dry mouth, second primary malignancies (other malignancies than the primary prostate cancer, including hematological and solid malignancies), dry eye. | Up to approximately 3 years |
| Proportion of Prescriptions by Type of Specialty | Baseline, up to approximately 3 years |
| Proportion of Prescriptions by Type of Practice Setting | Baseline, up to approximately 3 years |
| Proportion of Patients by Type of Other Metastatic Prostate Cancer (mPC) Treatments Prior to [177Lu]Lu-PSMA-617 Treatment | Baseline |
| Proportion of Patients by Type of Other mPC Treatments After [177Lu]Lu-PSMA-617 Treatment | Up to approximately 3 years |
| D009369 |
| Neoplasms |
| D005832 | Genital Diseases, Male |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D011469 | Prostatic Diseases |
| D052801 | Male Urogenital Diseases |
| D009385 | Neoplastic Processes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |