OBJECTIVES: To inform the content of a novel patient-reported outcome (PRO) measure to assess symptoms and impacts associated with hormonal-based treatments, specifically androgen deprivation therapy (ADT), on men with prostate cancer. While several prostate cancer-specific PRO measures exist, these do not adequately cover the spectrum of patient-relevant symptoms and impacts of hormonal-based treatments.

METHODS: Twelve men with prostate cancer who were receiving ADT participated in an audio‑recorded, semi‑structured concept elicitation (CE) interview over the telephone. Interviews explored participants’ experiences with ADT, focusing on ADT-related symptoms and their impacts. Interviews were transcribed verbatim and analyzed thematically to identify key symptoms and impacts through saturation analysis.

RESULTS: Findings are reported for 11 participants, after which saturation was reached. The mean (standard deviation [SD]) age of participants was 57.9 (6.6) years, 36.4% were African‑American, and the mean (SD) time on their most recent ADT was 15.5 (11.5) months. Key ADT‑related symptoms included fatigue or lack of energy (n=10), reduced sexual interest or desire (n=9), pain or tenderness at the injection site (n=9), hot flashes or night sweats (n=7), and difficulty maintaining an erection (n=7). Other symptoms, including loss of muscle mass, weight gain, sleep problems, dry mouth, cognitive difficulties, and joint pain or muscle stiffness, were mentioned by at least 4 participants. Impacts of ADT experienced by men included emotional aspects (eg, depression, anxiety, and self-image) and effects on physical activity, relationships, work, and social life. The results from these interviews led to a draft conceptual model for ADT‑specific symptoms and impacts.

CONCLUSION: The CE interviews provided rich qualitative data on symptom and impact experiences with ADT for men with prostate cancer. The findings were used to draft a de novo PRO tool focused on the patient-relevant symptoms and impacts of hormonal-based treatments for prostate cancer, which will be debriefed in further interviews.