Background/Objectives: There is scarce comparative effectiveness research assessing Patient-Reported Outcome Measures (PROMs) comparing the most established new modalities of treatment for patients with localized prostate cancer, and no randomized clinical trial has been published. This study aimed to compare, over a period of 5yr, the impact of active surveillance, robot-assisted radical prostatectomy (RARP), Intensity-Modulated Radiotherapy (IMRT), and real-time brachytherapy (BT) on patients with localized prostate cancer using PROMs.

Methods: Prospective observational study (ClinicalTrials.gov, NCT05523856) of 566 male patients diagnosed (2014-2021) with clinically localized prostate cancer (50-75 years old; stage cT1 or cT2, N0/Nx and M0/Mx; Gleason ≤ 6 or 7 [if 3 + 4 with T1c]; and PSA ≤ 10 ng/ml) and followed up to 5 years after primary treatment. The Expanded Prostate Cancer Index Composite (EPIC-26) was centrally administered via telephone interviews before treatment and annually thereafter. EPIC-26 measures urinary incontinence, urinary irritative/obstructive symptoms, sexual, bowel and hormonal domains. For evaluating the impact on the different domains, generalized estimating equation (GEE) models were constructed with propensity score-based weights.

Results: Weighted results of adjusted GEE models showed significant declines on sexual health along the 5yr, in all treatment groups (ranging from -22 to -27.6), but this worsening appeared earlier in the active treatment groups (RARP, IMRT and BT) than in active surveillance. The RARP group presented the greatest deterioration in urinary incontinence (-23.7 vs. -13.3 in active surveillance), while the greatest impairment in bowel symptoms was observed in both radiotherapy groups (-4.1 vs. +0.7 in active surveillance).

Conclusions/Recommendations: Our findings provide detailed novel evidence on the long-term impact of disease and treatment on patients with localized prostate cancer. While all treatment groups showed large sexual deterioration overtime, important differences in urinary incontinence (highest after RARP) and bowel symptoms (after IMRT and BT) persisted along 5 yr after. These findings are crucial for allowing patients diagnosed with localized prostate cancer to performed informed shared decision-making.

Funding: ISCIII PI21/00023, AECC PRYES223070FERR.