Quality of life in low-risk prostate cancer under active surveillance or following radical treatments: the START cohort study

Background: Real-world evidence on quality of life (QoL) changes associated with treatment decisions is crucial for informed choices by patients with low-risk prostate cancer (LRPC). Methods: A prospective cohort study was conducted in the Piemonte and Valle d’Aosta Regional Oncology Network, NW Italy (4.5 million population), including nearly all urology (N = 22) and radiation oncology (N = 6) centres. Patients newly diagnosed with LRPC, eligible for radical treatments, received balanced information on risks and benefits of available options and could choose among active surveillance (AS), radical prostatectomy (RP), or radiotherapy (RT). Longitudinal changes in QoL were assessed via patient-reported outcomes in four domains: general QoL, mental health, sexual function and urinary/bowel symptoms. The main comparison was between AS and RP. A secondary comparison was between AS and all radical treatments (RP or RT). Data were analysed by multivariable generalised linear or logistic models, following the intention-to-treat principle and accounting for correlation within centres and subjects. Results: A total of 651 patients (76.4% of those enrolled, 559 in AS, 76 in RP and 16 in RT) with baseline questionnaires were included (median [IQR] age, 70 [64–74] years). During a median follow-up of 37 months, no differences in general QoL or mental health were observed between AS and RP. Men in AS had better scores for sexual function (β = 8.27, 95% CI: 5.57–10.96) and activity (β = 6.70, 95% CI: 4.19–9.20). Use of incontinence aids was significantly lower in the AS group (OR = 0.14; 95% CI: 0.09–0.23). Prostatic obstructive symptoms remained stable in AS but decreased in the RP group (OR = 2.77; 95% CI: 1.52–5.06). Results were similar comparing AS to RP or RT. Conclusions: Compared to radical prostatectomy, AS preserved urinary continence and sexual function but was associated with persistent obstructive symptoms, without differences in general QoL or mental health. This real-world study supports existing evidence, aiding LRPC patients in making informed decisions.