Metastatic Prostate CancerPULSENCT07484269
PULSE Registry: for Patients Receiving Lutetium (177Lu) Vipivotide Tetraxetan
An observational study of Metastatic Prostate Cancer, run by Novartis Pharmaceuticals at 1 site in Switzerland.
Trial 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 Read more about this study
- Who is it for?
- Any age, men only
- Conditions the study is for
- Metastatic Prostate Cancer
- How many people
- 753 participants
- Where
- 1 siteSwitzerland
- Study dates
- 30 Sep 2026to 31 Jul 2031
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- Men only
- No healthy volunteers
- Child, Adult, Older adult
Study population: All patients with confirmed diagnosis of metastatic prostate cancer and treatment with at least one dose of lutetium (177Lu) vipivotide tetraxetan
Who may be able to join
- 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
Who cannot join
- 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)
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Novartis Pharmaceuticals contact
Switzerland1 site, 1 recruiting
- Recruiting
Novartis Investigative SIte
Basel, 4056
About this study
Official title: 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
Read the 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.
- Conditions
- Metastatic Prostate Cancer
- Keywords
- Prostate cancer, metastatic prostate cancer
- Medical subject headings
- Prostatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
Profile of patient demographics (e.g., age, race)
Measured: Baseline
Number of participants by clinical characteristics
e.g., symptoms/physical signs of PC and metastasis, metastasis location)
Measured: Baseline
real-world overall survival (rwOS)
Measured: 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
Measured: 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
Measured: 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)
Measured: 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
Measured: 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
Measured: 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
≥ 30% decrease in PSA from date of lutetium (177Lu) vipivotide tetraxetan initiation [index date]
Measured: 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
≥ 50% decrease in PSA from index date
Measured: 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
≥ 90% decrease in PSA from index date
Measured: 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 to treatment response for PSA 30, PSA 50, and PSA 90
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 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)
Patients with evidence of AESIs, including, but not limited to, renal events, myelosuppression, dry eye, dry mouth, and second primary malignancies
Measured: 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
i.e., between first and second, second and third, third and fourth, fourth and fifth, and fifth and sixth cycles
Measured: 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)
Measured: 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
Number and proportion of patients with a change in frequency of lutetium (177Lu) vipivotide tetraxetan cycles relative to the recommended frequency in the label
Measured: 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
Measured: 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
Persistence (time to discontinuation): time from the index date until the date of last dose of lutetium (177Lu) vipivotide tetraxetan administration
Measured: 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
1L: first line
Measured: 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+
2L: second line
Measured: 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 from diagnosis of mPC to the index date
Measured: 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 from index date until the start date of the next treatment
Measured: 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)
aggregate time between the end date of one regimen/treatment and the start date of the next regimen/treatment for all treatments
Measured: 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
aggregate time of all treatment patterns from treatment/line initiation to discontinuation within each treatment (mean time on a given treatment for all patients)
Measured: 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.
Measured: 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
Number and proportion of patients switching treatment, defined as discontinuation of lutetium (177Lu) vipivotide tetraxetan and initiation of new drug(s)
Measured: 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
Measured: 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
Measured: 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
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Mar 2026
- Study start30 Sep 2026
- Primary completion31 Jul 2031 (estimated)
- Study completion31 Jul 2031 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Metastatic Prostate CancerStudies of the same condition, open and under way.
- More trials run by Novartis PharmaceuticalsThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 753 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Novartis Pharmaceuticals
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Novartis Pharmaceuticals, Study director, Novartis Pharmaceuticals
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07484269
- Sponsor's protocol ID
- CAAA617A02001
- Acronym
- PULSE
- Status last verified
- Oct 2026
- First submitted
- 16 Mar 2026
- Last updated
- 30 Oct 2026
- Results posted
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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)
- ClinicalTrials.gov ID
- NCT07484269
- Acronym / sponsor ID
- PULSE / CAAA617A02001
- Conditions
- Metastatic Prostate Cancer
- Keywords
- Prostate cancer, metastatic prostate cancer
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 753 participants (estimated)
- Lead sponsor
- Novartis PharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- 30 Sep 2026 (actual)
- Primary completion
- 31 Jul 2031 (estimated)
- Study completion
- 31 Jul 2031 (estimated)
- First posted
- 20 Mar 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The primary objective of the study is to describe real-world drug utilisation of lutetium (177Lu) vipivotide tetraxetan among patients with metastatic prostate cancer
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 design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| lutetium (177Lu) vipivotide tetraxetan | – | –Patients with metastatic prostate cancer who are treated with lutetium (177Lu) vipivotide tetraxetan over a five-year followup period |
Who may qualify
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- All patients with confirmed diagnosis of metastatic prostate cancer and treatment with at least one dose of lutetium (177Lu) vipivotide tetraxetan
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (1 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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
31 secondary outcomes
Patient demographics
Time frame: Baseline
Number of participants by clinical characteristics
Time frame: 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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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 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
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
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
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
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 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
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Oct 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Novartis Pharmaceuticals contact
Novartis Pharmaceuticals study director
Novartis Pharmaceuticals
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Metastatic Prostate Cancer, run by Novartis Pharmaceuticals at 1 site in Switzerland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 30 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Novartis Pharmaceuticals (+41613241111, novartis.email@novartis.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Oct 2026.