Development and Validation of the PREVES-HOR Questionnaire: A Patient-Reported Measure of Hormone Therapy-Related Quality of Life in Prostate Cancer Patients Undergoing Androgen Deprivation Therapy

Introduction: The burden of androgen deprivation therapy (ADT) is only partially captured by legacy prostate cancer questionnaires, which devote few items to hormonal sequelae. Patient-Reported Evaluation of the Effects of Hormone Therapy (PREVES-HOR) is a 29-item, distress-anchored instrument developed to quantify ADT-specific physical, emotional, cognitive, sexual, and body image morbidity from a patient-centered, subjective perspective. We report the prespecified phase 1 psychometric evaluation. Methods: Italian-speaking men receiving ADT were consecutively enrolled. Participants completed PREVES-HOR plus external comparators for fatigue (REST), mood (HEAL-BDLC), sleep (PEACE), and well-being (WHO-5). Internal consistency was estimated with Cronbach's α and McDonald's ω; convergent validity with Spearman correlations; dimensionality with exploratory factor analysis (polychoric matrix, principal axis factoring, oblimin rotation, parallel analysis). Results: One hundred and forty-five patients were analyzed. PREVES-HOR showed excellent reliability (α = 0.95; McDonald's ω = 0.97; domain α/ω 0.80-0.95). Six factors - physical fatigue and pain, emotional well-being, mental clarity, quality of life, relationships and stress, sexual health and body image - accounted for 79% of variance, with a dominant general distress factor (∼50%). All but four items had communalities ≥0.40 and cross-loadings <0.30. Total PREVES-HOR correlated strongly with fatigue (REST ρ = 0.69) and depression/anxiety (HEAL-BDLC ρ = 0.78) and inversely with well-being (WHO-5 ρ = -0.49) and sleep quality (PEACE ρ = -0.37), confirming convergent but nonredundant validity. Conclusion: Phase 1 findings support PREVES-HOR's content validity, internal coherence, and ability to detect clinically meaningful distress overlooked by broader instruments such as EPIC or FACT-P. Its forced-choice format eliminated missing data but will be reconsidered, along with responsiveness, test-retest stability, and cross-cultural adaptation, in the ongoing 1,000 patient phase 2/3 program. Pending confirmation, PREVES-HOR, may become a complementary tool for individualizing supportive care and evaluating ADT-modifying interventions.