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NCT Number: NCT07484269

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

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

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Key information

Conditions

Metastatic Prostate Cancer Genital Diseases Genital Diseases, Male Genital Neoplasms, Male Male Urogenital Diseases Neoplasms Neoplasms by Site Prostatic Diseases Prostatic Neoplasms Urogenital Diseases Urogenital Neoplasms

Sex eligibility

Male

Study type

Observational

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Primary outcomes

  1. 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

Secondary outcomes

  1. Patient demographics

    Time frame: Baseline

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

  2. Number of participants by clinical characteristics

    Time frame: Baseline

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

  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

  5. 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

  6. 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

  7. 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

  8. 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

  9. 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]

  10. 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

  11. 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

  12. 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

  13. 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

  14. 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

  15. 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

  16. 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

  17. 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

  18. 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

  19. 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

  20. 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

  21. 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

  22. 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

  23. 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

  24. 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

  25. 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

  26. 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

  27. 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)

  28. 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

  29. 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)

  30. 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

  31. 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

Study contacts

Contact information is provided by the study sponsor or research team.

Novartis Pharmaceuticals

CONTACT

[email protected]

+41613241111

Novartis Pharmaceuticals

CONTACT

Sponsors and collaborators

Lead sponsor

Novartis Pharmaceuticals

Industry

Registry information

Official study 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)

Acronym: PULSE

Important dates

Study start
2026
Primary completion
2031
Study completion
2031
First posted
Mar 20, 2026
Registry last updated
Mar 20, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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