Real-world Experience With Lutetium Vipivotide Tetraxetan in Metastatic Castration Resistant Prostate Cancer

Официальное название

Real-world Experience With Lutetium (177Lu) Vipivotide Tetraxetan in Metastatic Castration Resistant Prostate Cancer, an Observational, Multicenter, Prospective Cohort Study

Обзор

The purpose of this study is to describe routine clinical practice with lutetium (177Lu) vipivotide tetraxetan on Health related quality of life (HRQoL) at baseline, on treatment, and post progression.

Подробное описание

This non-interventional observational, prospective cohort study is using primary data collection to describe the routine clinical practice and HRQoL of patients with Metastatic castration-resistant prostate cancer (mCRPC) initiating lutetium (177Lu) vipivotide tetraxetan using patient questionnaires.

Data will be collected at the following time points: pre-index (if patient is eligible), index date (first application of lutetium (177Lu) vipivotide tetraxetan), during treatment, at EoT, and during follow-up.

The duration of a treatment cycle is 6 weeks (± 1 week). Patients will be treated for up to 6 cycles (as per local label).

EoT visit / assessments will be performed after the last lutetium (177Lu) vipivotide tetraxetan application.

Follow-up period: patient data will be collected if available up to 1 year after EoT.

Вмешательства

• Другое lutetium (177Lu) vipivotide tetraxetan
  This is an observational study. There is no treatment allocation. The decision to initiate lutetium vipivotide tetraxetan will be based solely on clinical judgement.

Первичные конечные точки

• Functional Assessment of Cancer Therapy - Prostate (FACT-P) [Срок оценки: Baseline, up to 1 year after end of treatment]
• Change from baseline in FACT-P [Срок оценки: Baseline, up to 1 year after end of treatment]
• Functional Assessment of Cancer Therapy-Radionuclid Therapy (FACT-RNT) [Срок оценки: Baseline, up to 1 year after end of treatment]
• Change from baseline in FACT-RNT [Срок оценки: Baseline, up to 1 year after end of treatment]
• Brief Pain Inventory-Short Form (BPI-SF) [Срок оценки: Baseline, up to 1 year after end of treatment]
• Change from baseline in BPI-SF [Срок оценки: Baseline, up to 1 year after end of treatment]
• Radiographic progression [Срок оценки: Up to 1 year after end of treatment]
• Clinical progression [Срок оценки: Up to 1 year after end of treatment]
• Time to prostate-specific antigen (PSA) progression [Срок оценки: Up to 1 year after end of treatment]
• Prostate-specific antigen (PSA) 30/50/90 [Срок оценки: Up to 1 year after end of treatment]

Критерии участия

Критерии включения

All patients must meet the following inclusion criteria during the identification period:

• Adult male patients diagnosed with mCRPC and initiating lutetium (177Lu) vipivotide tetraxetan by treating physician as per local label. After treatment decision enrollment is allowed before date of cycle 1 or within 2 weeks after the date of Cycle 1.
• ≥ 18 years old at the time of enrollment
• Written informed consent must be obtained prior to any data collection
• Willing to participate in Quality of Life post treatment date collection for 1 year

Критерии исключения

Patients must not meet the following exclusion criterion during the identification period:

\- Simultaneous participation in any investigational trial or simultaneous participation in another Novartis-sponsored non-interventional study with lutetium (177Lu) vipivotide tetraxetan

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Модель наблюдения

Когортное

Центры проведения

Германия · 38 центров

• Novartis Investigative Site — Konstanz
• Novartis Investigative Site — Stuttgart
• Novartis Investigative Site — Munich
• Novartis Investigative Site — Regensburg
• Novartis Investigative Site — Würzburg
• Novartis Investigative Site — Cottbus
• Novartis Investigative Site — Frankfurt (Oder)
• Novartis Investigative Site — Ludwigshafen
• … и ещё 30 центров

Идентификаторы

NCT: NCT06517719 · CAAA617A1DE04

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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