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

Last updated: January 12, 2025
Sponsor: Novartis Pharmaceuticals
Overall Status: Active - Recruiting

Phase

N/A

Condition

Prostate Cancer

Prostate Disorders

Urologic Cancer

Treatment

lutetium (177Lu) vipivotide tetraxetan

Clinical Study ID

NCT06517719
CAAA617A1DE04
  • Ages 18-99
  • Male

Study Summary

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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

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

  • Adult male patients diagnosed with mCRPC and initiating lutetium (177Lu) vipivotidetetraxetan by treating physician as per local label. After treatment decisionenrollment is allowed before date of cycle 1 or within 2 weeks after the date ofCycle 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

Exclusion Criteria:

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

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

Study Design

Total Participants: 500
Treatment Group(s): 1
Primary Treatment: lutetium (177Lu) vipivotide tetraxetan
Phase:
Study Start date:
September 04, 2024
Estimated Completion Date:
February 01, 2028

Study 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.

Connect with a study center

  • Novartis Investigative Site

    Konstanz, Baden Wuerttemberg 78464
    Germany

    Active - Recruiting

  • Novartis Investigative Site

    Regensburg, Bavaria 93053
    Germany

    Active - Recruiting

  • Novartis Investigative Site

    Aachen, 52074
    Germany

    Active - Recruiting

  • Novartis Investigative Site

    Augsburg, 86179
    Germany

    Active - Recruiting

  • Novartis Investigative Site

    Berlin, 13125
    Germany

    Active - Recruiting

  • Novartis Investigative Site

    Bielefeld, 33611
    Germany

    Active - Recruiting

  • Novartis Investigative Site

    Bonn, 53105
    Germany

    Active - Recruiting

  • Novartis Investigative Site

    Chemnitz, 09113
    Germany

    Active - Recruiting

  • Novartis Investigative Site

    Essen, 45147
    Germany

    Active - Recruiting

  • Novartis Investigative Site

    Halle S, 06120
    Germany

    Active - Recruiting

  • Novartis Investigative Site

    Jena, 07740
    Germany

    Active - Recruiting

  • Novartis Investigative Site

    Magdeburg, 39120
    Germany

    Active - Recruiting

  • Novartis Investigative Site

    Trier, 54290
    Germany

    Active - Recruiting

  • Novartis Investigative Site

    Tuebingen, 72076
    Germany

    Active - Recruiting

  • Novartis Investigative Site

    Ulm, 89081
    Germany

    Active - Recruiting

  • Novartis Investigative Site

    Wuerzburg, 97080
    Germany

    Active - Recruiting

Not the study for you?

Let us help you find the best match. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.