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The primary objective of the study is to describe real-world drug utilisation of lutetium (177Lu) vipivotide tetraxetan among patients with metastatic prostate cancer
This study is planned as a multicountry, non-interventional, longitudinal AI-enhanced digital registry that will leverage advanced data extraction technologies to efficiently generate RWD.
The primary objective of the study is to describe real-world drug utilisation of lutetium (177Lu) vipivotide tetraxetan among patients with metastatic prostate cancer.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| lutetium (177Lu) vipivotide tetraxetan | Patients with metastatic prostate cancer who are treated with lutetium (177Lu) vipivotide tetraxetan over a five-year followup period |
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| Measure | Description | Time Frame |
|---|---|---|
| Proportion and number of patients who receive any given number of lutetium (177Lu) vipivotide tetraxetan cycles | To describe real-world drug utilisation of lutetium (177Lu) vipivotide tetraxetan among mPC patients | From the date of the first administration of lutetium (177Lu) vipivotide tetraxetan (index date) until the end of follow-up, up to 5 years |
| Measure | Description | Time Frame |
|---|---|---|
| Patient demographics | Profile of patient demographics (e.g., age, race) | Baseline |
| Number of participants by clinical characteristics | e.g., symptoms/physical signs of PC and metastasis, metastasis location) |
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Inclusion criteria:
Age ≥ 18 years at index date
Exclusion criterion:
• Current or prior participation in an investigational study within the 30-day period immediately prior to and including the index date, or within five half-lives of the investigational product (whichever is longer)
As recorded in the EHR
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All patients with confirmed diagnosis of metastatic prostate cancer and treatment with at least one dose of lutetium (177Lu) vipivotide tetraxetan
| 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 |
|---|---|
| D011471 | Prostatic Neoplasms |
| ID | Term |
|---|---|
| D005834 | Genital Neoplasms, Male |
| D014565 | Urogenital Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
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| Baseline |
| real-world overall survival (rwOS) | Date of the first administration of lutetium (177Lu) vipivotide tetraxetan (index date) until the earliest of end of follow-up or last available EHR record, or the event date, up to 5 years |
| median rwOS | Date of the first administration of lutetium (177Lu) vipivotide tetraxetan (index date) until the earliest of end of follow-up or last available EHR record, or the event date, up to 5 years |
| Five-year rwOS | Date of the first administration of lutetium (177Lu) vipivotide tetraxetan (index date) until the earliest of end of follow-up or last available EHR record, or the event date, up to 5 years |
| Real-world progression-free survival (rwPFS) | Date of the first administration of lutetium (177Lu) vipivotide tetraxetan (index date) until the earliest of end of follow-up or last available EHR record, or the event date, up to 5 years |
| Median rwPFS | Date of the first administration of lutetium (177Lu) vipivotide tetraxetan (index date) until the earliest of end of follow-up or last available EHR record, or the event date, up to 5 years |
| Five-year rwPFS | Date of the first administration of lutetium (177Lu) vipivotide tetraxetan (index date) until the earliest of end of follow-up or last available EHR record, or the event date, up to 5 years |
| PSA 30 response rate | ≥ 30% decrease in PSA from date of lutetium (177Lu) vipivotide tetraxetan initiation [index date] | From the date of the first administration of lutetium (177Lu) vipivotide tetraxetan (index date) until the end of follow-up, up to 5 years |
| PSA 50 response rate | ≥ 50% decrease in PSA from index date | From the date of the first administration of lutetium (177Lu) vipivotide tetraxetan (index date) until the end of follow-up, up to 5 years |
| PSA 90 response rate | ≥ 90% decrease in PSA from index date | From the date of the first administration of lutetium (177Lu) vipivotide tetraxetan (index date) until the end of follow-up, up to 5 years |
| Time to treatment response | Time to treatment response for PSA 30, PSA 50, and PSA 90 | From the date of the first administration of lutetium (177Lu) vipivotide tetraxetan (index date) until the end of follow-up, up to 5 years |
| Best overall response (BOR) | From the date of the first administration of lutetium (177Lu) vipivotide tetraxetan (index date) until the end of follow-up, up to 5 years |
| Overall response rate (ORR) | From the date of the first administration of lutetium (177Lu) vipivotide tetraxetan (index date) until the end of follow-up, up to 5 years |
| Duration of response (DOR) | From the date of the first administration of lutetium (177Lu) vipivotide tetraxetan (index date) until the end of follow-up, up to 5 years |
| Patients with evidence of adverse event of special interest (AESIs) | Patients with evidence of AESIs, including, but not limited to, renal events, myelosuppression, dry eye, dry mouth, and second primary malignancies | From the date of the first administration of lutetium (177Lu) vipivotide tetraxetan (index date) until the end of follow-up, up to 5 years |
| Time interval between two consecutive cycles of lutetium (177Lu) vipivotide tetraxetan | i.e., between first and second, second and third, third and fourth, fourth and fifth, and fifth and sixth cycles | From the date of the first administration of lutetium (177Lu) vipivotide tetraxetan (index date) until the end of follow-up or when applicable measured from mPC diagnosis to the index date, up to 5 years |
| Number and proportion of patients with a change in lutetium (177Lu) | From the date of the first administration of lutetium (177Lu) vipivotide tetraxetan (index date) until the end of follow-up or when applicable measured from mPC diagnosis to the index date, up to 5 years |
| Number and proportion of patients with a change in frequency of lutetium (177Lu) vipivotide tetraxetan cycles | Number and proportion of patients with a change in frequency of lutetium (177Lu) vipivotide tetraxetan cycles relative to the recommended frequency in the label | From the date of the first administration of lutetium (177Lu) vipivotide tetraxetan (index date) until the end of follow-up or when applicable measured from mPC diagnosis to the index date, up to 5 years |
| Time to first change in dose or frequency of lutetium (177Lu) vipivotide tetraxetan relative to the recommendations in the label | From the date of the first administration of lutetium (177Lu) vipivotide tetraxetan (index date) until the end of follow-up or when applicable measured from mPC diagnosis to the index date, up to 5 years |
| Time to discontinuation | Persistence (time to discontinuation): time from the index date until the date of last dose of lutetium (177Lu) vipivotide tetraxetan administration | From the date of the first administration of lutetium (177Lu) vipivotide tetraxetan (index date) until the end of follow-up or when applicable measured from mPC diagnosis to the index date, up to 5 years |
| Number and proportion of newly diagnosed mPC patients treated with lutetium (177Lu) vipivotide tetraxetan as 1L | 1L: first line | From the date of the first administration of lutetium (177Lu) vipivotide tetraxetan (index date) until the end of follow-up or when applicable measured from mPC diagnosis to the index date, up to 5 years |
| Number and proportion of mPC patients treated with lutetium (177Lu) vipivotide tetraxetan as 2L or 2L+ | 2L: second line | From the date of the first administration of lutetium (177Lu) vipivotide tetraxetan (index date) until the end of follow-up or when applicable measured from mPC diagnosis to the index date, up to 5 years |
| Time to treatment initiation (TTI) | time from diagnosis of mPC to the index date | From the date of the first administration of lutetium (177Lu) vipivotide tetraxetan (index date) until the end of follow-up or when applicable measured from mPC diagnosis to the index date, up to 5 years |
| Time to next treatment (TTNT) | time from index date until the start date of the next treatment | From the date of the first administration of lutetium (177Lu) vipivotide tetraxetan (index date) until the end of follow-up or when applicable measured from mPC diagnosis to the index date, up to 5 years |
| Treatment free interval (TFI) | aggregate time between the end date of one regimen/treatment and the start date of the next regimen/treatment for all treatments | From the date of the first administration of lutetium (177Lu) vipivotide tetraxetan (index date) until the end of follow-up or when applicable measured from mPC diagnosis to the index date, up to 5 years |
| Duration of treatment | aggregate time of all treatment patterns from treatment/line initiation to discontinuation within each treatment (mean time on a given treatment for all patients) | From the date of the first administration of lutetium (177Lu) vipivotide tetraxetan (index date) until the end of follow-up or when applicable measured from mPC diagnosis to the index date, up to 5 years |
| Number and proportion of patients discontinuing lutetium (177Lu) vipivotide tetraxetan documented by physician in the medical charts as discontinued. | From the date of the first administration of lutetium (177Lu) vipivotide tetraxetan (index date) until the end of follow-up or when applicable measured from mPC diagnosis to the index date, up to 5 years |
| Number and proportion of patients switching treatment | Number and proportion of patients switching treatment, defined as discontinuation of lutetium (177Lu) vipivotide tetraxetan and initiation of new drug(s) | From the date of the first administration of lutetium (177Lu) vipivotide tetraxetan (index date) until the end of follow-up or when applicable measured from mPC diagnosis to the index date, up to 5 years |
| Number and proportion of patients who received each treatment prior to lutetium (177Lu) vipivotide tetraxetan administration since diagnosis of mPC | From the date of the first administration of lutetium (177Lu) vipivotide tetraxetan (index date) until the end of follow-up or when applicable measured from mPC diagnosis to the index date, up to 5 years |
| Number and proportion of patients who received each treatment following initiation of lutetium (177Lu) vipivotide tetraxetan | From the date of the first administration of lutetium (177Lu) vipivotide tetraxetan (index date) until the end of follow-up or when applicable measured from mPC diagnosis to the index date, up to 5 years |
| D005832 |
| Genital Diseases, Male |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D011469 | Prostatic Diseases |
| D052801 | Male Urogenital Diseases |