PRE-POET: a qualitative interview-based study to explore patient-relevant factors in the context of prostate biopsy.

[INTRODUCTION] Prostate biopsy is a key diagnostic tool for prostate cancer and is often associated with physical, emotional, and social challenges. To enhance future multicenter trial designs for diagnostic precision, understanding patient-relevant outcomes is essential. Current evidence on patient-reported outcomes (PROMs) and patient-reported experience measures (PREMs) in the context of prostate biopsies remains limited, particularly regarding perioperative biopsychosocial impacts. This study aimed to explore patient-relevant factors, including concerns, side effect tolerance, and preferences, to inform future trials through patient and public involvement (PPI).

[METHODOLOGY] A prospective monocentric qualitative study was conducted with 12 male patients (mean age: 69.8 years) who underwent prostate biopsy. Preprocedure semistructured telephone-based interviews were conducted from May to August 2024 in Freiburg, Germany, transcribed verbatim, and analyzed via deductive-inductive content analysis. Intercoder reliability reached a kappa of 0.73. A short questionnaire was used to collect background data. The interviews addressed themes such as study motivation, fears, diagnostic precision, side effects, communication preferences, and other outcomes relevant to patients.

[RESULTS] The participants expressed fears about physical side effects (e.g., pain, incontinence, and erectile dysfunction) and potential cancer diagnoses. While most patients tolerate temporary side effects for the sake of diagnostic accuracy, potential long-term effects raise concerns. Trust in the medical team's expertise, the reputation of the medical center, and transparent communication were identified as crucial for patient satisfaction. Many participants showed altruistic motivation to contribute to research but emphasized the importance of shorter waiting times and clear communication regarding biopsy risks and benefits. The biopsychosocial model was evident, as patients reported interconnected physical, psychological, and social burdens. Preferences for open, empathetic communication and reduced procedural invasiveness were recurrent themes.

[CONCLUSIONS] This study highlights the multidimensional nature of patient experiences with prostate biopsy, emphasizing the importance of patient-centered research. Transparent communication, trust, and minimizing invasiveness while ensuring diagnostic accuracy are essential for improving patient satisfaction and reducing anxiety. The findings provide valuable insights for designing future studies and underline the importance of incorporating patient-relevant outcomes in clinical research and decision-making.

[TRIAL REGISTRATION] This study was registered at the University Medical Center of Freiburg Clinical Trial Register (FRKS005027).