PULSE Registry: for Patients Receiving Lutetium (177Lu) Vipivotide Tetraxetan

NCT07484269 | Not Yet Recruiting

• 1 other identifier: CAAA617A02001
• Study Type: observational
• Target: 753
• Locations: 0 countries
• Sites: N/A

Brief Summary

The primary objective of the study is to describe real-world drug utilisation of lutetium (177Lu) vipivotide tetraxetan among patients with metastatic prostate cancer

Conditions

Metastatic Prostate Cancer

Keywords

Prostate cancer; metastatic prostate cancer

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (31)

• Patient demographics

  Baseline

• Number of participants by clinical characteristics

  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

Study Arms (1)

lutetium (177Lu) vipivotide tetraxetan

Patients with metastatic prostate cancer who are treated with lutetium (177Lu) vipivotide tetraxetan over a five-year followup period

Eligibility Criteria

• Gender Eligibility Details: As recorded in the EHR
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

All patients with confirmed diagnosis of metastatic prostate cancer and treatment with at least one dose of lutetium (177Lu) vipivotide tetraxetan

You may qualify if:

• Age ≥ 18 years at index date
• Diagnosis of mPC
• PSMA positive
• Received at least one dose of lutetium (177Lu) vipivotide tetraxetan on or after mPC diagnosis date
• 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)

Sponsors & Collaborators

• Novartis Pharmaceuticals: lead

MeSH Terms

Conditions

Prostatic Neoplasms

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases

Study Officials

• Novartis Pharmaceuticals

  Novartis Pharmaceuticals

  STUDY DIRECTOR

Central Study Contacts

Novartis Pharmaceuticals

CONTACT

+41613241111; novartis.email@novartis.com

Novartis Pharmaceuticals

CONTACT

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 16, 2026
• First Posted: March 20, 2026
• Study Start (Estimated): August 1, 2026
• Primary Completion (Estimated): July 31, 2031
• Study Completion (Estimated): July 31, 2031
• Last Updated: March 20, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share