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Real-world Use of Lutetium (177Lu) Vipivotide Tetraxetan in China(PSMAreal CN)

NCT ID: NCT07290270

Last Updated: 2025-12-18

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Total Enrollment

170 participants

Study Classification

OBSERVATIONAL

Study Start Date

2025-12-22

Study Completion Date

2029-08-31

Brief Summary

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This non-interventional, observational, multicenter, prospective cohort study is designed to investigate the treatment patterns of mPC patients treated with lutetium (177Lu) vipivotide tetraxetan, as well as their clinical outcomes, real-world characteristics, and quality of life during the treatment period and up to one year after treatment completion.

Detailed Description

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The study population will be divided into two cohorts, enrolling patients with mCRPC and mHSPC, respectively. Patients planned to receive lutetium (177Lu) vipivotide tetraxetan treatment according to treating physician's assessment will be enrolled in the study upon signing an informed consent form. Patients must meet all inclusion criteria defined in the protocol and not meet any exclusion criteria. The patients' medical history, prostate cancer disease characteristics, demographics, and baseline data will be collected through medical records and examination reports. Treatment patterns, treatment outcomes, and HRQoL data will be collected during study follow-up visits through patient records, examination reports, and self-reported data. This study does not have a control group; instead, a self-control method will be used, with the patients' baseline data before the start of treatment serving as the control for efficacy, safety, and HRQoL assessments. The index date for this study is defined as the date of the first administration of lutetium (177Lu) vipivotide tetraxetan

Conditions

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Metastatic Prostate Cancer

Keywords

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Metastatic Prostate Cancer Metastatic Castration-Resistant Prostate Cancer Metastatic Hormone-Sensitive Prostate Cancer Lutetium (177Lu) vipivotide tetraxetan Injection Non-interventional Study China

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Cohort 1

Patients diagnosed with Metastatic Castration-Resistant Prostate Cancer (mCRPC) previously treated with at least one ARPI with or without taxane regimens.

No interventions assigned to this group

Cohort 2

Patients diagnosed with Metastatic Hormone-Sensitive Prostate Cancer (mHSPC).

No interventions assigned to this group

Eligibility Criteria

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Inclusion Criteria

Adult male patients diagnosed with mCRPC or mHSPC Initiating lutetium (177Lu) vipivotide tetraxetan treatment by treating physician as per local label. After treatment decision enrollment is allowed before date of cycle 1 or within 2 weeks after the date of cycle 1 Written ICF must be obtained prior to any data collection Participants must have adequate organ function following Society of Nuclear Medicine and Molecular Imaging (SNMMI) consensus (Hope et al., 2023)

Exclusion Criteria

Simultaneous participation in any investigational trial or simultaneous participation in another Novartis-sponsored non-interventional study with lutetium (177Lu) vipivotide tetraxetan during the study period
Minimum Eligible Age

18 Years

Maximum Eligible Age

99 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

No

Sponsors

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Novartis Pharmaceuticals

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Novartis Pjharmaceuticals

Role: STUDY_DIRECTOR

Novartis Pjharmaceuticals

Central Contacts

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Novartis Pharmaceuticals

Role: CONTACT

Phone: +41613241111

Email: [email protected]

Novartis Pharmaceuticals

Role: CONTACT

Other Identifiers

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CAAA617A1CN01

Identifier Type: -

Identifier Source: org_study_id