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)

Study identification

• EU PAS number:
  EUPAS1000000935
• Study ID:
  1000000935
• Official title and acronym:
  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)
• DARWIN EU® study:
  No
• Study countries:
  Canada

  Germany

  Italy

  Portugal

  Switzerland
• Study description:
  This study is planned as a multicountry, non-interventional, longitudinal registry using language processing technology, to periodically extract and structure clinical data documented in electronic health records (EHR) of patients with mPC who are treated with lutetium (177Lu) vipivotide tetraxetan as part of routine clinical care.;
• Study status:
  Planned

Research institutions and networks

Institutions

Novartis Pharmaceuticals

Study timelines

Date when funding contract was signed

Actual:26/03/2025

Study start date

Planned:01/08/2026

Data analysis start date

Planned:31/07/2031

Date of final study report

Planned:28/11/2031

Sources of funding

Pharmaceutical company and other private sector 

More details on funding

Novartis Pharma AG

Regulatory

• Was the study required by a regulatory body?:
  No
• Is the study required by a Risk Management Plan (RMP)?:
  Not applicable

Other study registration identification numbers and links

CAAA617A02001