A non-interventional, real-world study of HRRm testing, treatment patterns, and overall survival among patients with metastatic castration-resistant prostate cancer initiating treatment with talazoparib plus enzaluatime in the US.

Study identification

• EU PAS number:
  EUPAS1000000963
• Study ID:
  1000000963
• Official title and acronym:
  A non-interventional, real-world study of HRRm testing, treatment patterns, and overall survival among patients with metastatic castration-resistant prostate cancer initiating treatment with talazoparib plus enzaluatime in the US.
• DARWIN EU® study:
  No
• Study countries:
  United States
• Study description:
  On the basis of the positive results from the TALAPRO-2 clinical trial, talazoparib in combination with enzalutamide was approved for treating adults with HRR gene mutated mCRPC. Current National Comprehensive Cancer Network (NCCN) clinical practice guidelines recommend germline and somatic tumor testing for HRR gene alterations in all patients with metastatic, regional, or high-risk localized prostate cancer to identify eligibility for ARPIs. However, studies have shown that HRRm testing rates in mCRPC have been suboptimal. Additionally, as this is a newly approved therapy, the real-world treatment patterns are not well understood. The current study aims to assess the patient demographics, clinical characteristics, HRRm testing, treatment patterns, rwTTNT, rwTTD, duration of treatment, and rwOS among patients with mCRPC treated with talazoparib plus enzalutamide.
• Study status:
  Ongoing

Research institutions and networks

Institutions

Genesis Research Group

Study timelines

Date when funding contract was signed

Planned:11/03/2025

Actual:11/03/2025

Study start date

Planned:02/06/2025

Actual:02/06/2025

Data analysis start date

Planned:01/12/2026

Date of final study report

Planned:30/03/2027

Sources of funding

Pharmaceutical company and other private sector 

More details on funding

Pfizer Inc

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

C3441072