On 12th March 2023, the latest findings from the ProtecT trial were presented at the European Association of Urology (EAU) Congress in Milan. After 15 years of follow-up, the results of this trial show that patients undergoing active monitoring of localised prostate cancer (PCa) display similarly high survival rates as patients treated with radiotherapy or surgery. These findings indicate that treatment decisions following diagnosis of PCa do not need to be rushed, as delaying treatment for localised prostate cancer does not increase mortality risk.
In the last years, the widespread use of prostate-specific antigen (PSA) testing has resulted in a dramatic increase in the diagnosis and treatment of prostate cancer (PCa) by surgery, radiotherapy, or just monitoring. However, PCa often progresses slowly, and many men do not benefit from intervention and die of competing causes. In addition, interventions for PCa can have adverse effects on sexual, urinary, or bowel function. In this setting, the Prostate Testing for Cancer and Treatment (ProtecT) trial, supported by the National Institute for Health Research in the United Kingdom, compared the long-term effectiveness of surgery, radiotherapy, and monitoring for the treatment of clinically localised PCa. After 10 years of follow-up, no significant differences could be found in the survival rates among the treatments.1 The 15-year updated outcomes of this trial were recently presented, solidifying these earlier findings.
Between 1999 and 2009, the ProtecT trial enrolled 1,643 men aged 50-69 across the UK, who were diagnosed with localised PCa after a PSA blood test. These patients were assigned to active monitoring (n=545), radical prostatectomy (n=553) or radical radiotherapy (n=545). The research team followed the men over an average of 15 years to measure mortality rates, cancer progression and spread, and the impact of treatments on quality of life.2,3
This study found that around 97% of the men diagnosed with PCa survived 15 years after diagnosis, irrespective of which treatment they received. Death from PCa occurred in 45 men, with similar death rates among the groups (3.1% in the active-monitoring group, 2.2% in the prostatectomy group, and 2.9% in the radiotherapy group; p=0.53). Additionally, around a quarter of the patients on active monitoring did not receive any invasive treatment for their cancer after 15 years. Patients from all three groups reported similar overall quality of life, in terms of their general mental and physical health. However, the negative impacts of radiotherapy and surgery on urinary and sexual function persist for up to 12 years. This is much longer than previously thought.2,3
These findings show that, unlike many other cancers, delaying treatment initiation following diagnosis for low and intermediate-risk localised PCa will not adversely affect the survival of the patients. This gives more time to clinicians and patients to choose the most appropriate treatment option for each individual case. Additionally, it is an important message for patients and clinicians that delaying treatment is safe, especially as that means delaying side effects as well.2
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