The ADAPP trial: a two-year longitudinal multidisciplinary intervention study for prostate cancer frail patients on androgen deprivation associated to curative radiotherapy

Abstract

Background: Androgen deprivation (AD) therapy combined to radiotherapy (RT) is a curative therapeutic option for patients with non-metastatic locally advanced or aggressive intermediate prostate cancer (PC), though with a range of nutritional, physical, and psychological side effects. A multidisciplinary care program was created to help frail patients to prevent and manage those side effects. Material and methods: We conducted a longitudinal interventional study in frail patients, presenting either cardiovascular/pulmonary comorbidities, old age (≥75 years), vulnerability ratings, or balance impairment. Patients were treated by AD and RT and, benefited from nutritional coaching, supervised biweekly 45 minute physical training, and psychological counseling for two years. Treatment outcomes included PC-related quality of life (QoL), body mass index, fat mass index, and fat-free mass index derived from bioelectrical impedance analysis, Six-Minute Walk Test, Timed Up&Go, handgrip strength, Hospital Anxiety and Depression scale, Mini Mental State Examination. Measures were repeated after zero, three, six, nine, 12, 18, 24 months, and 12-months post-study follow-up. A prospective mixed-model design was used to assess longitudinal outcome. Results: Regression analyses revealed no significant change over the two years, including post-study follow-up. Means of QoL, nutritional, physical, as well as psychological variables remained stable over more than two years in the 35 men aged 74 (range 68–76) years. Conclusion: The expected side effects of AD and RT were not observed in frail PC patients who followed this multidisciplinary care program.