A core outcome set for localised prostate cancer effectiveness trials

Area of Science:

• Oncology
• Clinical Trials Methodology
• Health Outcomes Research

Background:

• Localized prostate cancer has numerous treatments, but inconsistent outcome reporting in trials hinders optimal therapeutic ratio determination.
• Variability in outcome selection, definition, measurement, and reporting complicates effectiveness comparisons.

Purpose of the Study:

• To develop a universally applicable core outcome set (COS) for effectiveness trials of localized prostate cancer interventions.
• To standardize outcome measurement across diverse treatment modalities for localized prostate cancer.

Main Methods:

• Systematic review of 79 outcomes from effectiveness studies and patient interviews.
• Two-stage consensus process: three-round Delphi survey followed by a consensus panel meeting.
• Involved 118 patients and 56 international healthcare professionals (HCPs).

Main Results:

• A final core outcome set (COS) of 19 outcomes was established.
• 12 outcomes are applicable to all interventions (e.g., survival, recurrence, quality of life, function).
• 7 outcomes are intervention-specific (e.g., surgical margins, treatment failure, side effects).

Conclusions:

• A comprehensive COS for localized prostate cancer effectiveness trials has been established.
• This COS ensures consistent measurement across all interventions, enhancing trial comparability.
• While developed with UK participants, the COS is intended for broad applicability, requiring justification for non-use elsewhere.