Lutetium (177Lu) vipivotide tetraxetan treatment for men with metastatic prostate cancer in China
Real-world Use of Lutetium (177Lu) Vipivotide Tetraxetan Injection in Metastatic Prostate Cancer: an Observational, Multicenter, Prospective Cohort Study in China (PSMAreal CN)
This study will try lutetium (177Lu) vipivotide tetraxetan in men in China with metastatic prostate cancer (both castration-resistant and hormone-sensitive) to see how it is used, how patients do, and how their quality of life changes.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 170 (estimated) |
| Ages | 18 Years to 99 Years |
| Sex | Male |
| Sponsor | Novartis Industry-sponsored |
| Locations | 1 site (Shanghai, Shanghai Municipality) |
| Trial ID | NCT07290270 on ClinicalTrials.gov |
What this trial studies
This is a non-interventional, prospective, multicenter cohort study enrolling men with metastatic castration-resistant or hormone-sensitive prostate cancer who are planned to receive lutetium (177Lu) vipivotide tetraxetan per their treating physician. Patients will be enrolled around the time of their first treatment dose and followed during therapy and for up to one year after treatment completion. Data collected will include medical history, disease characteristics, treatment patterns, clinical outcomes, safety, and patient-reported health-related quality of life drawn from medical records and self-reports. There is no randomized control group; each patient’s baseline data before treatment will serve as the comparator for outcome and safety analyses.
Who should consider this trial
Good fit: Adult men in China with metastatic prostate cancer (mCRPC or mHSPC) whom their physician plans to treat with lutetium (177Lu) vipivotide tetraxetan and who meet required organ function and consent criteria are eligible.
Not a fit: Patients already participating in other investigational trials or Novartis-sponsored non-interventional studies with the same drug, or those who do not meet organ function or follow-up requirements, may not receive benefit from participation.
Why it matters
Potential benefit: If successful, this study could clarify real-world safety, outcomes, and quality-of-life effects of lutetium (177Lu) vipivotide tetraxetan in Chinese patients and help inform treatment decisions locally.
How similar studies have performed: Randomized trials and real-world reports outside China have shown clinical benefit for 177Lu-PSMA therapies in mCRPC, but real-world data specific to Chinese populations remain limited.
Eligibility criteria
Show full inclusion / exclusion criteria
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 Other protocol-defined inclusion / exclusion criteria may apply
Where this trial is running
Shanghai, Shanghai Municipality
- Novartis Investigative Site — Shanghai, Shanghai Municipality, China (Recruiting)
Study contacts
- Study coordinator: Novartis Pharmaceuticals
- Email: novartis.email@novartis.com
- Phone: +41613241111
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.