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

Novartis

Status

Enrolling

Conditions

Metastatic Castration Resistant Prostate Cancer

Treatments

Other: lutetium (177Lu) vipivotide tetraxetan

Study type

Observational

Funder types

Industry

Identifiers

NCT06517719

CAAA617A1DE04

Details and patient eligibility

About

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.

Full description

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.

Enrollment

500 estimated patients

Sex

Male

Ages

18 to 99 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

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

Exclusion criteria

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