Introduction: The BIOCaPPE clinical study (Biomarkers and Prostate Cancer/Prevention and Environment) aims to identify biomarkers of prostate cancer (PCa) risk that are modifiable by lifestyle. Enrolled participants filled out many questionnaires, including their clinical situation. However, the accuracy of patient-reported outcomes (PROs) related to PCa is unclear. Our aim was to assess the reliability of self-reported PCa medical data in comparison to validated data. Our objective is to refine PCa assessment tools and determine the usefulness of PCa-related PROs.

Methods: Targeted data on clinical events related to prostate biopsies, prostate-specific antigen (PSA) tests, and medical imaging were extracted from self-reported questionnaires of the BIOCaPPE participants, and from their respective medical charts. Data were analyzed on three aspects: declaration of a clinical event, reported date, and reported result. Non-identical information was flagged and categorized according to the corresponding type of inconsistency. A portrait of sensitivity and specificity was drawn up.

Results: Following the analysis of the 1934 questionnaires available, magnetic resonance imaging (MRI)-related PRO obtained a specificity of 84.2% and a sensitivity of 99.1% with regard to the statement of having had an MRI, its date, and its result. Of these, 1698 questionnaires were perfectly consistent for the three aspects, 23 were almost entirely consistent, 147 were consistent but incomplete, 21 were inconsistent and incomplete, and 45 were inconsistent (erroneous information, declared non-existent event, or undeclared events).

Conclusions: Self-reported PCa-related MRI data by patients of the BIOCaPPE project was consistent and reliable, with almost 90% of the questionnaires being consistent or almost entirely consistent. Similar work is needed for PSA and prostate biopsies in order to generalize the usefulness of self-reported PCa data, and use such a tool in a general clinical context.