Treatment and Clinical Characteristics in Patients with Metastatic Castration-Resistant Prostate Cancer (mCRPC) using Talazoparib and Enzalutamide (tala+enza) Combination Therapy

Study identification

• EU PAS number:
  EUPAS1000000580
• Study ID:
  1000000580
• Official title and acronym:
  Treatment and Clinical Characteristics in Patients with Metastatic Castration-Resistant Prostate Cancer (mCRPC) using Talazoparib and Enzalutamide (tala+enza) Combination Therapy
• DARWIN EU® study:
  No
• Study countries:
  United States
• Study description:
  This non-interventional study will be conducted using secondary data collection with human review of unstructured data (clinical notes) from the Mass General Brigham (MGB) Research Patient Data Registry (RPDR) to describe the patient demographic, clinical (including HRRm status), treatment (including dose management, treatment persistence, and reasons for treatment discontinuation), and AEs characteristics in patients with mCRPC treated under real-world routine clinical care with tala+enza.
• Study status:
  Ongoing

Research institutions and networks

Institutions

Pfizer

Study timelines

Date when funding contract was signed

Planned:01/11/2024

Actual:01/11/2024

Study start date

Planned:01/08/2025

Actual:12/08/2025

Date of final study report

Planned:31/12/2025

Regulatory

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