EAU 2023: 15-year Update ProtecT trial - Part II: Quality of Life

(UroToday.com) The 2023 European Association of Urology (EAU) annual congress held in Milan, Italy between March 10th and 13th, 2023 was host to a plenary session addressing the “right management” of prostate cancer patients in the early detection and active surveillance settings. Professor Jenny Donovan presented the updated 15-year quality of life (QoL) outcomes of the PROstate TEsting for Cancer and Treatment (ProtecT) trial, which were concurrently published at midnight in the open-access New England Journal of Medicine: Evidence.1

In this updated 15-year report from the ProtecT trial, the investigators evaluated patient-reported outcomes (PROMs) using validated measure of:

  • Urinary function and impact on quality of life: ICIQ, ICSmaleSF, EPIC-50
  • Sexual and bowel function and impact on quality of life: EPIC-50
  • Health-related quality of life: SF-12, EQ-5D, HADS, EORTC QLQ-C30 

Patients were assessed annually for 12 complete years, and response rates were over 80% for most measures and timepoints across all arms. Professor Donovan addressed potential concerns regarding the applicability of these results to modern practice, particularly with the emergence of robotic approaches to radical prostatectomy. However, numerous reports over the past 5 years have demonstrated no significant differences in PROMs across the various surgical and radiotherapy techniques, reassuring us that results from the ProtecT trial may be reliably applied to contemporary practice.

There were no differences with regards to health-related quality of life as demonstrated below:

quality of life.jpg

At 12-year follow-up, urinary leakage, defined as 1 or more pads per day, continued to be significantly worse in the prostatectomy arm:

  • Radical prostatectomy: 24%
  • Active monitoring: 11%
  • Radiotherapy: 8%

urinary leakage.jpg

With regards to sexual function, as previously reported, we observe a sharp decline in sexual function in the immediate post-radical therapy setting. However, at 12 years, there were no significant differences between the three arms:

  • Radical prostatectomy: 13%
  • Active monitoring: 17%
  • Radiotherapy: 15% 

sexual function.jpgBowel function at 12 years was significantly worse in the radiotherapy arm at 12%, compared to 6% in the radical prostatectomy and active monitoring arms.

bowel function.jpg

Professor Donovan concluded her presentation with the following key messages:

  • Side effects of radical treatments (including new techniques) can continue to affect some men’s lives 12 years after treatment
  • Each treatment approach has a particular profile of effects long term
  • Men newly diagnosed with localized prostate cancer can now carefully assess the trade-offs between the benefits and harms of treatment options
    • In the short, medium, and long-term
    • Using their own values and priorities
    • To make prudent and well-informed treatment decisions

Presented by: Jenny L Donovan, Liverpool, PhD, FMedSci, FFPH, NIHR SI, AcSS, OBE, Professor of Social Medicine, Bristol Medical Scool, Bristol, England

Written by: Rashid K. Sayyid, MD, MSc – Society of Urologic Oncology (SUO) Clinical Fellow at The University of Toronto, @rksayyid on Twitter during the 2023 European Association of Urology (EAU) Annual Meeting, Milan, IT, Fri, Mar 10 – Mon, Mar 13, 2023.


  1. Donovan, et al. Patient-Reported Outcomes 12 Years after Localized Prostate Cancer Treatment. NEJM Evidence, 2023. DOI:10.1056/EVIDoa2300018
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EAU 2023: 15-year Update ProtecT Trial - Part I: Oncology