KEY TAKEAWAYS
- The ARNEO phase 2 trial aimed to assess 2-year QoL outcomes in high-risk patients with prostate cancer receiving neoadjuvant degarelix +/- apalutamide before radical prostatectomy.
- The primary endpoint was MRD.
- The study found no significant QoL differences between degarelix + apalutamide versus degarelix + placebo over 2 years.
Gaëtan Devos and the team conducted a study that aimed to present the two-year quality of life (QoL) outcomes from the ARNEO trial, a randomized phase II study.
This double-blind, placebo-controlled trial assessed the impact of neoadjuvant degarelix with or without apalutamide for 12 weeks before radical prostatectomy in patients with high-risk prostate cancer (n=99).
The surgical specimen’s primary endpoint was minimal residual disease (MRD). Initial findings, published in European Urology in 2023, revealed that patients receiving degarelix + apalutamide intervention achieved a notably higher minimal residual disease rate compared to the control arm (38% versus 9%; RR: 4.2, 95% CI: 1.5 – 11, P= 0.002).
The study aimed to compare QoL outcomes between intensified treatment and androgen deprivation therapy (ADT) in the neoadjuvant setting before surgery. Patients underwent serial assessments using the International Consultation on Incontinence Questionnaire-Urinary Incontinence (ICIQ-UI), International Index of Erectile Function-5 (IIEF-5), and EORTC Core Quality of Life Questionnaire (QLQ-C30).
Assessments occurred before neoadjuvant treatment initiation, after twelve weeks of treatment, post-surgery, and annually up to three years postoperatively.
Patients with ≥2 years of follow-up completed questionnaires at predetermined intervals. Regarding ICIQ-UI questionnaire (score range: 0 – 21 points; lower scores indicating better outcomes), no significant differences were observed at any evaluated study time points.
The comparison across different time points revealed distinct patterns. Initially, there were no differences between the groups at study inclusion or before radical prostatectomy.
However, following the procedure, Group A scored a higher score of 10.5 compared to Group B’s 9. Subsequently, at the 1-year mark post-radical prostatectomy, both groups experienced reductions, with Group A declining to 4 and Group B to 3. After 2 years, Group A’s score decreased to 5, while Group B’s remained steady at 3.
The study found no significant differences in various scores between the two groups at different time points
Throughout the study, both groups had similar scores on the designated scale. Before radical prostatectomy, neither group showed a notable difference in scores, with both reporting minimal disparity.
Post-radical prostatectomy, the scores were marginally different but not statistically significant. At 1 and 2 years post-radical prostatectomy, both groups demonstrated comparable outcomes.
Similarly, the IIEF-5 scores remained consistent across time points, with no significant differences observed. The scores for global health (QLQ-C30) did not show substantial distinctions between the two arms throughout the study period.
The study indicated that over the 2-year follow-up period, patients treated with degarelix + apalutamide exhibited comparable quality-of-life outcomes to those receiving degarelix + placebo, based on assessments using the ICIQ-UI, IIEF-5, and QLQ-C30 questionnaires.
The trial was sponsored by the Universitaire Ziekenhuizen KU Leuven.
Source: https://scientific-programme.uroweb.org/EAU24/programme
Clinical Trial: https://clinicaltrials.gov/study/NCT03080116
Devos G, Tosco L, Baldewijns M, et al. (2024) “Two-year quality of life (QoL) outcomes of the randomized phase II trial ARNEO: neoadjuvant degarelix with or without apalutamide prior to radical prostatectomy for high-risk prostate cancer.” Presented at EAU 2024.
