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

March 16, 2026 updated by: Novartis Pharmaceuticals

Understanding Drug Utilisation, Treatment Patterns, Clinical Outcomes, and Profile of the Patients Receiving Lutetium (177Lu) Vipivotide Tetraxetan for the Treatment of Metastatic Prostate Cancer: a Multicountry, AI-powered Registry (PULSE)

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

Study Overview

Status

Not yet recruiting

Conditions

Detailed Description

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.

Study Type

Observational

Enrollment (Estimated)

753

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

  • Name: Novartis Pharmaceuticals

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

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

Description

Inclusion criteria:

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

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)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Proportion and number of patients who receive any given number of lutetium (177Lu) vipivotide tetraxetan cycles
Time Frame: From the date of the first administration of lutetium (177Lu) vipivotide tetraxetan (index date) until the end of follow-up, up to 5 years
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Patient demographics
Time Frame: Baseline
Profile of patient demographics (e.g., age, race)
Baseline
Number of participants by clinical characteristics
Time Frame: Baseline
e.g., symptoms/physical signs of PC and metastasis, metastasis location)
Baseline
real-world overall survival (rwOS)
Time Frame: 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
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
Time Frame: 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
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
Time Frame: 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
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)
Time Frame: 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
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
Time Frame: 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
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
Time Frame: 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
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
Time Frame: From the date of the first administration of lutetium (177Lu) vipivotide tetraxetan (index date) until the end of follow-up, up to 5 years
≥ 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
Time Frame: From the date of the first administration of lutetium (177Lu) vipivotide tetraxetan (index date) until the end of follow-up, up to 5 years
≥ 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
Time Frame: From the date of the first administration of lutetium (177Lu) vipivotide tetraxetan (index date) until the end of follow-up, up to 5 years
≥ 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 Frame: 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 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)
Time Frame: From the date of the first administration of lutetium (177Lu) vipivotide tetraxetan (index date) until the end of follow-up, up to 5 years
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)
Time Frame: From the date of the first administration of lutetium (177Lu) vipivotide tetraxetan (index date) until the end of follow-up, up to 5 years
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)
Time Frame: From the date of the first administration of lutetium (177Lu) vipivotide tetraxetan (index date) until the end of follow-up, up to 5 years
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)
Time Frame: 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 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
Time Frame: 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
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)
Time Frame: 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
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
Time Frame: 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 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
Time Frame: 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
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
Time Frame: 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
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
Time Frame: 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
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+
Time Frame: 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
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 Frame: 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 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 Frame: 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 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)
Time Frame: 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
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
Time Frame: 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
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.
Time Frame: 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
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
Time Frame: 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, 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
Time Frame: 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
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
Time Frame: 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
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Novartis Pharmaceuticals

Investigators

  • Study Director: Novartis Pharmaceuticals, Novartis Pharmaceuticals

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

August 1, 2026

Primary Completion (Estimated)

July 31, 2031

Study Completion (Estimated)

July 31, 2031

Study Registration Dates

First Submitted

March 16, 2026

First Submitted That Met QC Criteria

March 16, 2026

First Posted (Actual)

March 20, 2026

Study Record Updates

Last Update Posted (Actual)

March 20, 2026

Last Update Submitted That Met QC Criteria

March 16, 2026

Last Verified

March 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CAAA617A02001

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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