05 Apr Prostate Cancer: 15 Year Follow Up Compares Treatment with Surgery, Radiation and Active Surveillance
MedicalResearch.com Interview with:
Prof. Hamdy
Freddie C. Hamdy FRCS, FMedSci
Nuffield Professor of Surgery, University of Oxford
Prof. Donovan
Jenny L. Donovan PhD, FMedSci
Professor of Social Medicine, University of Bristol
MedicalResearch.com: What is the background for this study?
Response: Prostate cancer is a common malignancy in men. Prostate cancer diagnosis is made largely through opportunistic screening with a PSA (Prostate Specific Antigen) blood test, followed by prostate biopsies. The ProtecT study, funded by the National Institute for Health and Care Research in the UK, is the largest randomised trial of treatment in screen-detected localised prostate cancer. The study began by testing 82,429 men between the ages of 50 and 69 years, across nine UK centres with a PSA blood test, followed by biopsies of the prostate if the PSA level was elevated. 2,664 men with clinically localised prostate cancer were found. From these, 1,643 (62%) agreed to be randomised to Surgery (radical prostatectomy to remove the prostate gland), Radiotherapy (external beam with a period of hormone treatment beforehand), or Active Monitoring (where men received regular checks and further investigations, with change to radical treatment as necessary). The men were carefully followed up for an average of 15 years. In parallel, the side-effects of treatments and quality of life of these men was investigated using patient-reported outcomes included in an annual study questionnaire completed for at least 12 years.
MedicalResearch.com: What are the main findings?
Response: Survival rates were very high (97%) [Hamdy et al, 2023]. Only 3% died from prostate cancer, and there were no differences between men allocated to surgery, radiotherapy, or active monitoring. Metastases developed in twice as many men under active monitoring compared with those who had radical treatment. The incidence of metastases was 9.4% compared with 4.8% and their development did not necessarily mean that men would die of prostate cancer. Many men developing metastases, particularly in the active monitoring group, survived over 15 years after the diagnosis. In addition, at the 15-year follow-up point a quarter of men allocated to active monitoring had not received any treatment and remained alive and well. This is remarkable and reassuring, even more so because a comprehensive re-evaluation of the baseline risk-stratification of the cohort indicated that two-thirds had low-risk prostate cancer and one third had intermediate-risk disease at diagnosis. The situation is very different for those who present with advanced disease which has grown outside the prostate or high-risk cancers – these need urgent treatment.
The ProtecT patient-reported outcomes showed that, while overall health-related quality of life was similar in all treatment groups, each caused a different profile of functional side-effects (Donovan et al]. Among men allocated to surgery, side-effects included leakage of urine and difficulties with sexual function (having an erection for intercourse). These side-effects were worse in the surgery group compared with those in the active monitoring or radiotherapy groups. Side-effects continued to affect some men 12 years after treatment, with some additional urinary and bowel problems emerging in the radiotherapy group in the longer term.
MedicalResearch.com: What should readers take away from your report?
Response: This is very good news. Most men with localised prostate cancer are likely to live for a long time, whether or not they receive invasive treatment and whether or not their disease has spread. Our study shows that men newly diagnosed with low- or intermediate- risk prostate cancer need to be given time to consider the trade-offs between the reduction of metastases and local progression with radical treatments against their short-, medium-, and long-term impacts on sexual, urinary, and bowel function. Rushing into decisions where there is no urgency and no known impact on outcomes can cause unnecessary harm and later regret. Discussion of active surveillance as a treatment option with clinicians is highly important for men with low-risk prostate cancer, and also men with intermediate-risk, clinically localised prostate cancer. Men with clinically localised prostate cancer should be made aware of the findings from ProtecT, so that they can better weigh up the benefits and harms of treatments. We hope clinicians will share the findings in the ProtecT study papers with patients to help with these difficult decisions.
Although our study is not about screening, we think the results showing how long men live with localized disease, irrespective of which treatment they have, should lead men to carefully consider all the potential consequences of having a PSA test before deciding to have one. A PSA test can be followed by further testing including biopsies of the prostate, and then, if a man is diagnosed with low- or intermediate-risk cancer, he will then face difficult decisions about treatment that may or may not be needed.
MedicalResearch.com: What recommendations do you have for future research as a results of this study?
Response: It is important to continue to follow up these men for at least 20 years after the diagnosis. We need to conduct more research to try to understand the biological and genetic features which characterise lethal prostate cancer. This will enable treatment to be targeted to individual patients at risk of dying from this widespread malignancy. The long-term nature of treatment side-effects also needs to be understood in more detail, particularly as some effects persist or worsen over 12 years.
References
Fifteen-Year Outcomes after Monitoring, Surgery, or Radiotherapy for Prostate Cancer
FC Hamdy, JL Donovan et al.
The New England Journal of Medicine (NEJM), published online March 2023.
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Patient-Reported Outcomes 12 Years after Localized Prostate Cancer Treatment
JL Donovan, FC Hamdy et al.
NEJM Evidence, published online March 2023.
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Disclosures: The ProtecT study was funded by the National Institute for Health and Care Research in the UK.
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