Observing Quality of Life and Cognitive Changes in Men With Metastatic Hormone-Sensitive Prostate Cancer Taking Androgen Receptor Pathway Inhibitors

What this Trial Is About

This research aims to evaluate quality of life, functional status, and cognitive outcomes in men with metastatic hormone-sensitive prostate cancer mHSPC who are receiving androgen receptor pathway inhibitors ARPIs alongside standard androgen deprivation therapy. The study focuses on ARPIs such as abiraterone acetate, apalutamide, enzalutamide, and darolutamide, depending on availability, to understand their effects in real-world settings on patients cognitive health and daily functioning. Participants will be observed without assigned treatment as this is a prospective, multicenter observational study involving 102 men newly diagnosed with mHSPC. They will receive ARPIs in combination with androgen deprivation therapy as part of routine care. Assessments will be conducted at baseline, 3 months, and 6 months to measure changes in cognitive function, fatigue, depression, sleep quality, clinical parameters, and treatment-related adverse events using validated Turkish questionnaires and clinical evaluations. During the study, participants will complete several patient-reported outcome measures including the Functional Assessment of Cancer Therapy-Cognitive Function FACT-Cog, Functional Assessment of Cancer Therapy-Fatigue FACT-F, Patient Health Questionnaire-9 PHQ-9, and Pittsburgh Sleep Quality Index PSQI. Researchers will also record clinical data, performance status, lab results, and adverse events over time. The main outcomes measured are changes in cognitive function and fatigue, with secondary outcomes covering depression, sleep quality, ECOG performance status, laboratory tests, and safety profiles. The study will last at least 6 months from treatment initiation.

Quality of Life, Functional and Cognitive Outcomes in Patients With Metastatic Hormone-Sensitive Prostate Cancer