An International, Multicenter, Prospective Non-Interventional Study of Real-World Treatment Outcomes in Patients with Metastatic Castrate Resistant Prostate Cancer (mCRPC) treated with Talazoparib and Enzalutamide (TALENZA)

Study identification

• PURI:
  https://redirect.ema.europa.eu/resource/106720
• EU PAS number:
  EUPAS106719
• Study ID:
  106720
• Official title and acronym:
  An International, Multicenter, Prospective Non-Interventional Study of Real-World Treatment Outcomes in Patients with Metastatic Castrate Resistant Prostate Cancer (mCRPC) treated with Talazoparib and Enzalutamide (TALENZA)
• DARWIN EU® study:
  No
• Study countries:
  Canada

  Germany

  United States
• Study description:
  This prospective, longitudinal non-interventional cohort study will evaluate the safety and effectiveness of talazoparib and enzalutatmide in patients ages 18 years and older who are treated for mCRPC with a follow-up period of ≤ 3 years. Approximately 150 patients will be recruited from primary care centers, oncology clinics, and academic centers from the US, Germany, and Canada with the potential to include additional countries from the IDM region. Study enrollment will begin once the combination of talazoparib and enzalutamide is approved by local Health Authorities in the respective study countries. The study will be open for enrollment for a period of 2 years after the first patient has been enrolled. Follow-up for overall survival beyond the prespecified study monitoring period may be taken into consideration on an individual basis. Each patient’s treatment will be consistent with routine practice, corresponding with the recommendations in the local Health Authority approved product label and at the discretion of the treating physician. Tumor or germline genotyping to identify alterations in HRR genes is not a required study procedure, however screening may be conducted as part of clinical care and will be captured for this study. Patients aged 18 and older with a confirmed diagnosis of mCRPC who are initiating treatment with talazoparib and enzalutamide according to routine clinical practice will be followed for up to 3 years, or until loss to follow up, death, or study termination, whichever occurs the earliest. Follow-up eCRFs will be completed when a patient returns for clinic visits per routine clinical practice with data collection permissible at the time of enrollment into the study (baseline) and during months 1, 3, 6, 12, 18, 24, 30, and 36. Reporting of adverse events will begin after informed consent is collected and will continue through 28 days after the last dose of talazoparib and enzalutamide.
• Study status:
  Planned

Research institutions and networks

Institutions

Pfizer

Syneos Health

United Kingdom

Multiple centres: 70 centres involved in the study

Study timelines

Date when funding contract was signed

Planned: 22/09/2023

Study start date

Planned: 31/12/2023

Data analysis start date

Planned: 30/04/2029

Date of interim report, if expected

Planned: 01/04/2026

Date of final study report

Planned: 31/07/2029

Sources of funding

Pharmaceutical company and other private sector 

More details on funding

Pfizer

Regulatory

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