Health-Related Quality of Life 24-Month after Prostate Cancer Diagnosis: An Update from the Pros-IT CNR Prospective Observational Study - Beyond the Abstract

Different therapeutic options for localized prostate cancer (PCa) are able to achieve similar results in terms of overall survival and local control. Each treatment may be associated with specific side effects associated with each and can influence patients’ quality of life (QoL). The evaluation of patient-reported outcomes measures is playing a growing role in the judgment of treatment quality and therefore, in patients’ counseling and decision-making process. In the current study,1 our group investigated the potential impact that radiation therapy, radical prostatectomy, and active surveillance may have on QoL outcomes measured at diagnosis, at 6-, 12- and 24-months from PCa diagnosis using real-world data from the PROState cancer monitoring in Italy (Pros-IT CNR) study. Briefly, the Pros-IT CNR study is a longitudinal, observational study that enrolled 1,705 treatment-naïve patients with histologically confirmed PCa from September 2014 to September 2015.2 The aim of the Pros-IT CNR study is to monitor QoL in PCa patients through validated questionnaires (SF-12 and UCLA-PCI questionnaires) that are administered at baseline and scheduled follow-ups from the diagnosis.3-8

Patients were grouped according to the treatment received: nerve-sparing radical prostatectomy (NSRP), non-nerve sparing radical prostatectomy (NNSRP), radiotherapy (RT), radiotherapy plus androgen deprivation (RT plus ADT), and active surveillance (AS). Mixed-effect models tested for changes in QoL scores related to each treatment group. Differences in QoL scores were interpreted as clinically significant if they were greater than the minimal clinically important differences (MCID), which was defined as half a standard deviation of each baseline domain from the Pros-IT CNR data.

Baseline urinary and bowel function scores were high across all treatment groups and ranged from 92 to 97 points. Sexual function scores at the baseline were higher in patients treated with NSRP (67), AS (61), and NNSRP (56), with respect to patients treated with RP or with RP plus ADT (38).

Our analyses confirmed that each treatment was relatively well-tolerated, albeit showing a different impact on QoL. The decline in urinary function was clinically significant, i.e. exceeded the MCID (10 points), at each time point (6-, 12- and 24-months) only in patients treated with radical prostatectomy. The decline in bowel function exceeded the MCID (7 points) only in patients treated with radiation therapy (RT and RT plus ADT groups) at 12 months. Nonetheless, at the 24-month follow-up, most patients recovered their bowel complaints. The decline in sexual function exceeded the MCID (14 points) at each time point in the NNSRP, NSRP, and RT plus ADT groups. The decrease in general physical status evaluated through SF-12 was generally small within each treatment with no variations larger than the MCID over time; on the contrary, mental status evaluated through SF-12 significantly increases at 12-months within each treatment group, even if the increases exceed the MCID (4 points) only among patients treated with either NSRP or NNSRP.

estimated means over time 1estimated means over time 2

Figures 1a-1d. Estimated means (error bands are 95% confidence interval [CI]) for UCLA-PCI and SF-12 (Physical Component Score, PCS; Mental Component Score, MCS) over time, by prostate cancer treatments (red: nerve-sparing radical prostatectomy; purple: non-nerve-sparing radical prostatectomy; blue: radiotherapy; yellow: radiotherapy plus androgen deprivation therapy; green: active surveillance)

Although a direct comparison with previous studies9-11 cannot be made due to different questionnaires and methodologies, consistent with previous reports, we showed that the most pronounced impact on QoL occurred within the first year from diagnosis and among patients with the highest scores at baseline.

Our findings may be helpful in counseling the patients on possible QoL impairment after each treatment. Indeed, these results underline that patient-reported outcome measures should be used to inform the patients after a prostate cancer diagnosis, alongside survival data. From this perspective, an appropriate discussion with a multidisciplinary team should be encouraged, in order to clearly explain the advantages and disadvantages of each treatment option. A patient-centered approach to treatment and shared decision-making may promote better compliance of treatment adherence and a reduction of negative feelings about QoL by patients.

Written by: Carlotta Palumbo, MD, Twitter: @CPalumbo87, Department of Urology, Maggiore della Carità Hospital, Novara, Italy; Marianna Noale, MSc, National Research Council, Neuroscience Institute, Padua, Italy; Stefania Maggi, MD, National Research Council, Neuroscience Institute, Padua, Italy; Alessandro Antonelli, MD, Twitter: @aleantonellibs1, Department of Urology, University of Verona, Verona, Italy


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