Health TrialsbyHealthPanel

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

ConditionMetastatic Prostate Cancer
Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexMale
AgeNot listed
SponsorNovartis Pharmaceuticals

About this trial

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

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Diagnosis of mPC

PSMA positive

Received at least one dose of lutetium (177Lu) vipivotide tetraxetan on or after mPC diagnosis date

Disqualifiers

None

Trial population

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

Trial design

Design model

Cohort

Time perspective

Retrospective

Treatments tested in this trial

Not listed

Trial groups

753 Participants
are grouped into 1 trial group
Group A: lutetium (177Lu) vipivotide tetraxetan

Trial outcomes

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

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

Secondary outcomes

1

Patient demographics

Profile of patient demographics (e.g., age, race)

Time frame
Baseline
2

Number of participants by clinical characteristics

e.g., symptoms/physical signs of PC and metastasis, metastasis location)

Time frame
Baseline
3

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
4

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

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Novartis Pharmaceuticals

Lead sponsor

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: