Cognitive status of prostate cancer (PCa) patients aged 60 years and older after a six-month gonadotropin-releasing hormone agonist (GnRHa) therapy, according to age groups: Secondary analysis of PRISME study.

Abstract

56 Background: Age is a risk factor for both PCa and cognitive impairment. Moreover, androgen deprivation therapy (ADT) is suspected to alter cognition, but little is known about the cognitive status of men starting ADT. Our purpose was to analyze cognitive status in 3 groups of age ([60-70[, [70-75[ and ≥ 75 years), before and after a 6-month GnRHa therapy. Methods: Between March 2018 and February 2020, a prospective, multicenter, longitudinal, non-interventional study was conducted in France (PRISME, NCT03516110). Urologists, radiation oncologists and medical oncologists recruited patients aged 60 years and older, with PCa, initiating a GnRHa therapy. 1000 patients were planned to be included 1:2:1 in prespecified age groups ([60-70[, [70-75[, ≥ 75 years). Cognitive status was evaluated through Mini Mental State Evaluation (MMSE) questionnaire (scores 0-30). Significant differences between groups were concluded in case of non-overlapping of the means 95% CIs, and significant changes in case of means 95% CIs not including 0. An analysis of covariance (ANCOVA) was performed to compare evolution of MMSE global score in subgroups of ages, adjusted on baseline scores (secondary effectiveness analysis). Post-hoc analyses of subgroups of level of education were also provided. Results: The final analysis included 652 patients (full analysis set population). Mean (±SD) age was 72.5±6.2 years. There were 193, 269 and 190 patients, in the [60-70[, [70-75[ and ≥75y age groups, respectively. 95.5% of patients had a Karnofsky score ≥ 80%; 71.6% had at least one comorbidity at baseline,65.0% were receiving at least one concomitant systemic treatment. Main reasons for GnRHa initiation were high risk PCa (65.3%), metastatic stage (18.4%), biochemical recurrence (13.3%). Mean [95% CI] baseline MMSE score was significantly lower in the ≥75y age group (26.2 [25.6-26.8]) than in the [60-70[ (27.9 [27.5-28.3]) and [70-75[ (27.6 [27.3-28.0]) age groups, with significantly more patients with cognitive impairment (MMSE < 26) in the ≥75y (30.9%) than in the [60-70[ (15.3%) and [70-75[ (14.7%) age groups. Baseline MMSE scores were significantly different between all level of education groups: 28.4 [28.0-28.7] in high, 27.2 [26.8-27.7] in middle and 24.7 [23.5-25.9] in low level groups. No significant changes in MMSE scores were observed after a 6-month GnRHa therapy inside age groups or inside level of education groups. Planned ANCOVA analyses found no statistically significant changes of MMSE global score from baseline between age groups. Conclusions: In this large observational cohort of PCa patients aged 60 years and older with prespecified age groups, cognitive status did not change after a 6-month GnRHa therapy, whatever the age group. Clinical trial information: NCT03516110.