Comparative effectiveness of new treatment modalities for localized prostate cancer through patient-reported outcome measures

Abstract

Active surveillance; Comparative effectiveness; Localized prostate cancer

Vigilància activa; Eficàcia comparativa; Càncer de pròstata localitzat

Vigilancia activa; Eficacia comparativa; Cáncer de próstata localizado

Purpose There is scarce comparative effectiveness research on the new treatment modalities for localized prostate cancer. We aim to compare through Patient-Reported Outcome Measures (PROMs) the impact of active surveillance, robot-assisted radical prostatectomy (RARP), intensity-modulated radiotherapy (IMRT), and real-time brachytherapy, considering side effects (incontinence, irritative/obstructive urinary symptoms, sexual dysfunction and bowel symptoms) and physical and mental health. Materials and Methods Prospective cohort of men diagnosed with clinically localized prostate cancer (age 50-75y, T1-T2, and low risk including Gleason 3 + 4 in T1c) from 18 Spanish hospitals, followed up to 24 months. Treatment decisions were jointly made by patients and physicians (n = 572). The Expanded Prostate cancer Index Composite (EPIC-26) and Short-Form 36 (SF-36v2) were administered through telephone interviews before and three, six, 12, and 24 months after treatment. To account for correlation among repeated measures, generalized estimating equation models were constructed. All analyses were performed with propensity score weights to solve treatment selection bias. Results The PROMs completion rate at 24 months was 95.0 %. Active surveillance entails the fewest side effects, but with significant sexual (0.4 standard deviations [SD], p < 0.001) and physical health deterioration (0.5 SD, p < 0.001); and moderate mental health improvement (0.4 SD, p = 0.001) at 24 months. Compared with active surveillance, RARP presented greater urinary incontinence (p = 0.030), and IMRT and real-time brachytherapy worse bowel symptoms (p = 0.027 and p = 0.007) at 24 months. Conclusions Most side effects of the new treatment modalities seem to be limited to short-term deteriorations, except for moderate-large urinary incontinence in patients who had undergone RARP and moderate bowel deterioration in patients treated with IMRT or with real-time brachytherapy. Furthermore, patients under active surveillance, IMRT, and real-time brachytherapy showed a moderate improvement in mental health.

The study was funded by the Instituto de Salud Carlos III and co-funded by the European Union (grant numbers PI21/00023, PI11/01191, and FI19/00229); Fundación Pública Andaluza Progreso y Salud de la Junta de Andalucía (grant number PI-0102–2011); Proyectos Estratégicos of the Fundación Científica Asociación Española Contra el Cáncer (PRYES223070FERR); Generalitat de Catalunya, Spain (grant numbers 2021 SGR 00624 and 2017 SGR 452); and the Movember Foundation’s TrueNTH Global Registry. The funders of the study had no role in the study concept and design, acquisition of data, support, analysis, or interpretation; they also had no role in the preparation, writing, reviewing, and submission of this manuscript.