Ignite Creation Date:
2026-03-26 @ 3:17 PM
Ignite Modification Date:
2026-04-03 @ 3:02 PM
Study NCT ID:
NCT07484269
Status:
NOT_YET_RECRUITING
Last Update Posted:
2026-03-20
First Post:
2026-03-16
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
PULSE Registry: for Patients Receiving Lutetium (177Lu) Vipivotide Tetraxetan
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2026-03-25'}, 'conditionBrowseModule': {'meshes': [{'id': 'D011471', 'term': 'Prostatic Neoplasms'}], 'ancestors': [{'id': 'D005834', 'term': 'Genital Neoplasms, Male'}, {'id': 'D014565', 'term': 'Urogenital Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D005832', 'term': 'Genital Diseases, Male'}, {'id': 'D000091662', 'term': 'Genital Diseases'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D011469', 'term': 'Prostatic Diseases'}, {'id': 'D052801', 'term': 'Male Urogenital Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 753}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2026-08-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2026-03', 'completionDateStruct': {'date': '2031-07-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2026-03-16', 'studyFirstSubmitDate': '2026-03-16', 'studyFirstSubmitQcDate': '2026-03-16', 'lastUpdatePostDateStruct': {'date': '2026-03-20', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2026-03-20', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2031-07-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Proportion and number of patients who receive any given number of lutetium (177Lu) vipivotide tetraxetan cycles', 'timeFrame': 'From the date of the first administration of lutetium (177Lu) vipivotide tetraxetan (index date) until the end of follow-up, up to 5 years', 'description': 'To describe real-world drug utilisation of lutetium (177Lu) vipivotide tetraxetan among mPC patients'}], 'secondaryOutcomes': [{'measure': 'Patient demographics', 'timeFrame': 'Baseline', 'description': 'Profile of patient demographics (e.g., age, race)'}, {'measure': 'Number of participants by clinical characteristics', 'timeFrame': 'Baseline', 'description': 'e.g., symptoms/physical signs of PC and metastasis, metastasis location)'}, {'measure': 'real-world overall survival (rwOS)', 'timeFrame': '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'}, {'measure': 'median rwOS', 'timeFrame': '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'}, {'measure': 'Five-year rwOS', 'timeFrame': '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'}, {'measure': 'Real-world progression-free survival (rwPFS)', 'timeFrame': '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'}, {'measure': 'Median rwPFS', 'timeFrame': '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'}, {'measure': 'Five-year rwPFS', 'timeFrame': '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'}, {'measure': 'PSA 30 response rate', 'timeFrame': 'From the date of the first administration of lutetium (177Lu) vipivotide tetraxetan (index date) until the end of follow-up, up to 5 years', 'description': '≥ 30% decrease in PSA from date of lutetium (177Lu) vipivotide tetraxetan initiation \\[index date\\]'}, {'measure': 'PSA 50 response rate', 'timeFrame': 'From the date of the first administration of lutetium (177Lu) vipivotide tetraxetan (index date) until the end of follow-up, up to 5 years', 'description': '≥ 50% decrease in PSA from index date'}, {'measure': 'PSA 90 response rate', 'timeFrame': 'From the date of the first administration of lutetium (177Lu) vipivotide tetraxetan (index date) until the end of follow-up, up to 5 years', 'description': '≥ 90% decrease in PSA from index date'}, {'measure': 'Time to treatment response', 'timeFrame': 'From the date of the first administration of lutetium (177Lu) vipivotide tetraxetan (index date) until the end of follow-up, up to 5 years', 'description': 'Time to treatment response for PSA 30, PSA 50, and PSA 90'}, {'measure': 'Best overall response (BOR)', 'timeFrame': 'From the date of the first administration of lutetium (177Lu) vipivotide tetraxetan (index date) until the end of follow-up, up to 5 years'}, {'measure': 'Overall response rate (ORR)', 'timeFrame': 'From the date of the first administration of lutetium (177Lu) vipivotide tetraxetan (index date) until the end of follow-up, up to 5 years'}, {'measure': 'Duration of response (DOR)', 'timeFrame': 'From the date of the first administration of lutetium (177Lu) vipivotide tetraxetan (index date) until the end of follow-up, up to 5 years'}, {'measure': 'Patients with evidence of adverse event of special interest (AESIs)', 'timeFrame': 'From the date of the first administration of lutetium (177Lu) vipivotide tetraxetan (index date) until the end of follow-up, up to 5 years', 'description': 'Patients with evidence of AESIs, including, but not limited to, renal events, myelosuppression, dry eye, dry mouth, and second primary malignancies'}, {'measure': 'Time interval between two consecutive cycles of lutetium (177Lu) vipivotide tetraxetan', 'timeFrame': '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', 'description': 'i.e., between first and second, second and third, third and fourth, fourth and fifth, and fifth and sixth cycles'}, {'measure': 'Number and proportion of patients with a change in lutetium (177Lu)', 'timeFrame': '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'}, {'measure': 'Number and proportion of patients with a change in frequency of lutetium (177Lu) vipivotide tetraxetan cycles', 'timeFrame': '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', 'description': 'Number and proportion of patients with a change in frequency of lutetium (177Lu) vipivotide tetraxetan cycles relative to the recommended frequency in the label'}, {'measure': 'Time to first change in dose or frequency of lutetium (177Lu) vipivotide tetraxetan relative to the recommendations in the label', 'timeFrame': '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'}, {'measure': 'Time to discontinuation', 'timeFrame': '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', 'description': 'Persistence (time to discontinuation): time from the index date until the date of last dose of lutetium (177Lu) vipivotide tetraxetan administration'}, {'measure': 'Number and proportion of newly diagnosed mPC patients treated with lutetium (177Lu) vipivotide tetraxetan as 1L', 'timeFrame': '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', 'description': '1L: first line'}, {'measure': 'Number and proportion of mPC patients treated with lutetium (177Lu) vipivotide tetraxetan as 2L or 2L+', 'timeFrame': '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', 'description': '2L: second line'}, {'measure': 'Time to treatment initiation (TTI)', 'timeFrame': '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', 'description': 'time from diagnosis of mPC to the index date'}, {'measure': 'Time to next treatment (TTNT)', 'timeFrame': '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', 'description': 'time from index date until the start date of the next treatment'}, {'measure': 'Treatment free interval (TFI)', 'timeFrame': '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', 'description': 'aggregate time between the end date of one regimen/treatment and the start date of the next regimen/treatment for all treatments'}, {'measure': 'Duration of treatment', 'timeFrame': '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', 'description': 'aggregate time of all treatment patterns from treatment/line initiation to discontinuation within each treatment (mean time on a given treatment for all patients)'}, {'measure': 'Number and proportion of patients discontinuing lutetium (177Lu) vipivotide tetraxetan documented by physician in the medical charts as discontinued.', 'timeFrame': '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'}, {'measure': 'Number and proportion of patients switching treatment', 'timeFrame': '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', 'description': 'Number and proportion of patients switching treatment, defined as discontinuation of lutetium (177Lu) vipivotide tetraxetan and initiation of new drug(s)'}, {'measure': 'Number and proportion of patients who received each treatment prior to lutetium (177Lu) vipivotide tetraxetan administration since diagnosis of mPC', 'timeFrame': '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'}, {'measure': 'Number and proportion of patients who received each treatment following initiation of lutetium (177Lu) vipivotide tetraxetan', 'timeFrame': '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'}]}, 'conditionsModule': {'keywords': ['Prostate cancer', 'metastatic prostate cancer'], 'conditions': ['Metastatic Prostate Cancer']}, 'descriptionModule': {'briefSummary': 'The primary objective of the study is to describe real-world drug utilisation of lutetium (177Lu) vipivotide tetraxetan among patients with metastatic prostate cancer', 'detailedDescription': '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.\n\nThe primary objective of the study is to describe real-world drug utilisation of lutetium (177Lu) vipivotide tetraxetan among patients with metastatic prostate cancer.'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'genderBased': True, 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'All patients with confirmed diagnosis of metastatic prostate cancer and treatment with at least one dose of lutetium (177Lu) vipivotide tetraxetan', 'genderDescription': 'As recorded in the EHR', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion criteria:\n\nAge ≥ 18 years at index date\n\n* Diagnosis of mPC\n* PSMA positive\n* Received at least one dose of lutetium (177Lu) vipivotide tetraxetan on or after mPC diagnosis date\n\nExclusion criterion:\n\n• 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)'}, 'identificationModule': {'nctId': 'NCT07484269', 'acronym': 'PULSE', 'briefTitle': 'PULSE Registry: for Patients Receiving Lutetium (177Lu) Vipivotide Tetraxetan', 'organization': {'class': 'INDUSTRY', 'fullName': 'Novartis'}, 'officialTitle': '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)', 'orgStudyIdInfo': {'id': 'CAAA617A02001'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'lutetium (177Lu) vipivotide tetraxetan', 'description': 'Patients with metastatic prostate cancer who are treated with lutetium (177Lu) vipivotide tetraxetan over a five-year followup period'}]}, 'contactsLocationsModule': {'centralContacts': [{'name': 'Novartis Pharmaceuticals', 'role': 'CONTACT', 'email': 'novartis.email@novartis.com', 'phone': '+41613241111'}, {'name': 'Novartis Pharmaceuticals', 'role': 'CONTACT'}], 'overallOfficials': [{'name': 'Novartis Pharmaceuticals', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Novartis Pharmaceuticals'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Novartis Pharmaceuticals', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}