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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

References:

  1. Palumbo, Carlotta, Alessio Bruni, Alessandro Antonelli, Walter Artibani, Pier Francesco Bassi, Filippo Bertoni, Paolo Borghetti et al. "Health-related quality of life 24-month after prostate cancer diagnosis: an update from the Pros-IT CNR prospective observational study." Minerva Urologica e Nefrologica= The Italian Journal of Urology and Nephrology (2021).
  2. Noale, Marianna, Stefania Maggi, Walter Artibani, Pier Francesco Bassi, Filippo Bertoni, Sergio Bracarda, Giario Natale Conti et al. "Pros-IT CNR: an Italian prostate cancer monitoring project." Aging clinical and experimental research 29, no. 2 (2017): 165-172.
  3. Porreca, Angelo, Marianna Noale, Walter Artibani, Pier Francesco Bassi, Filippo Bertoni, Sergio Bracarda, Giario Natale Conti et al. "Disease-specific and general health-related quality of life in newly diagnosed prostate cancer patients: the Pros-IT CNR study." Health and quality of life outcomes 16, no. 1 (2018): 1-11.
  4. Buglione, Michela, Marianna Noale, Alessio Bruni, Alessandro Antonelli, Filippo Bertoni, Renzo Corvo’, Umberto Ricardi et al. "Treatment paths for localised prostate cancer in Italy: The results of a multidisciplinary, observational, prospective study (Pros-IT CNR)." PloS one 14, no. 11 (2019): e0224151.
  5. Antonelli, Alessandro, Carlotta Palumbo, Marianna Noale, Angelo Porreca, Stefania Maggi, Claudio Simeone, Pierfrancesco Bassi et al. "Impact of surgical approach on patient-reported outcomes after radical prostatectomy: a propensity score-weighted analysis from a multicenter, prospective, observational study (The Pros-IT CNR Study)." Urologia internationalis 103, no. 1 (2019): 8-18.
  6. Antonelli, Alessandro, Carlotta Palumbo, Marianna Noale, Walter Artibani, Pierfrancesco Bassi, Filippo Bertoni, Sergio Bracarda et al. "Overview of potential determinants of radical prostatectomy versus radiation therapy in management of clinically localized prostate cancer: results from an Italian, prospective, observational study (the Pros-IT CNR study)." Minerva urologica e nefrologica= The Italian journal of urology and nephrology (2020).
  7. Gacci, Mauro, Walter Artibani, Pierfrancesco Bassi, Filippo Bertoni, Sergio Bracarda, Alberto Briganti, Giorgio Carmignani et al. "How radical prostatectomy procedures have changed over the last 10 years in Italy: a comparative analysis based on more than 1500 patients participating in the MIRROR-SIU/LUNA and the Pros-IT CNR study." World Journal of Urology (2020): 1-8.
  8. Gacci, Mauro, Isabella Greco, Walter Artibani, Pierfrancesco Bassi, Filippo Bertoni, Sergio Bracarda, Alberto Briganti et al. "The waiting time for prostate cancer treatment in Italy: analysis from the Pros-IT CNR study." Minerva Urologica e Nefrologica= The Italian Journal of Urology and Nephrology (2020).
  9. Barocas, Daniel A., JoAnn Alvarez, Matthew J. Resnick, Tatsuki Koyama, Karen E. Hoffman, Mark D. Tyson, Ralph Conwill et al. "Association between radiation therapy, surgery, or observation for localized prostate cancer and patient-reported outcomes after 3 years." Jama 317, no. 11 (2017): 1126-1140.
  10. Donovan, Jenny L., Freddie C. Hamdy, J. Lane, Malcolm Mason, Chris Metcalfe, Eleanor Walsh, Jane M. Blazeby et al. "Patient-reported outcomes after monitoring, surgery, or radiotherapy for prostate cancer." N Engl J Med 375 (2016): 1425-1437.
  11. Nguyen-Nielsen, Mary, Henrik Møller, Anne Tjønneland, and Michael Borre. "Patient-reported outcome measures after treatment for prostate cancer: Results from the Danish Prostate Cancer Registry (DAPROCAdata)." Cancer epidemiology 64 (2020): 101623.
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