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

NCT07290270 | Recruiting

• 1 other identifier: CAAA617A1CN01
• Study Type: observational
• Target: 170
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Metastatic Prostate Cancer

Keywords

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

Outcome Measures

Primary Outcomes (2)

• prostate-specific antigen (PSA) 50 response rate

  Defined as the proportion of patients with a confirmed decrease in PSA levels by ≥50% from baseline

  from 1 month before the index date through to 1 year after the end-of-treatment (EOT) visit

• prostate-specific antigen (PSA) 90 response rate

  Defined as the proportion of patients with confirmed decreases in PSA level by ≥90% from baseline

  from 1 month before the index date through to 1 year after the end-of-treatment (EOT) visit

Secondary Outcomes (33)

• Progression-Free Survival (PFS)

  Data collection for radiographic assessment outcomes: from 3 months before the index date to 1 year after the EOT visit / Data collection for non-radiographic assessment outcomes: from 1 month before the index date to 1 year after the EOT visit

• Radiographic progression-free survival (rPFS)

  Data collection for radiographic assessment outcomes: from 3 months before the index date to 1 year after the EOT visit / Data collection for non-radiographic assessment outcomes: from 1 month before the index date to 1 year after the EOT visit

• Clinical PFS

  Data collection for radiographic assessment outcomes: from 3 months before the index date to 1 year after the EOT visit / Data collection for non-radiographic assessment outcomes: from 1 month before the index date to 1 year after the EOT visit

• Time to PSA progression

  Data collection for radiographic assessment outcomes: from 3 months before the index date to 1 year after the EOT visit / Data collection for non-radiographic assessment outcomes: from 1 month before the index date to 1 year after the EOT visit

• Second Progression-Free Survival (PFS2)

  Data collection for radiographic assessment outcomes: from 3 months before the index date to 1 year after the EOT visit / Data collection for non-radiographic assessment outcomes: from 1 month before the index date to 1 year after the EOT visit

Study Arms (2)

Cohort 1

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

Cohort 2

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

Eligibility Criteria

• Age: 18 Years - 99 Years
• Gender Eligibility Details: male patients
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

The study population will be recruited from approximately 25 research centers in China

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• Novartis Pharmaceuticals: lead

Study Sites (1)

Novartis Investigative Site

Shanghai, Shanghai Municipality, China, China

RECRUITING

MeSH Terms

Conditions

Prostatic Neoplasms

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases

Study Officials

• Novartis Pharmaceuticals

  Novartis Pharmaceuticals

  STUDY DIRECTOR

Central Study Contacts

Novartis Pharmaceuticals

CONTACT

+41613241111; novartis.email@novartis.com

Novartis Pharmaceuticals

CONTACT

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 17, 2025
• First Posted: December 18, 2025
• Study Start: February 4, 2026
• Primary Completion (Estimated): August 31, 2029
• Study Completion (Estimated): August 31, 2029
• Last Updated: March 30, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)