A decades-long British study has found that more men with prostate cancer could afford to delay their treatment, and that active monitoring by healthcare professionals is an equally valid – and less harsh – option.
The study, published in the New England Journal of Medicine, followed more than 1 600 men newly diagnosed with localised prostate cancer in the UK. Up to 21 years after diagnosis, the researchers found that patients’ risk of dying from the disease was low regardless of whether they were actively monitored or treated with radiation or surgery, reports The Washington Post.
The latest findings from the ProtecT trial were presented at the recent European Association of Urology (EAU) Congress in Milan, and showed that more aggressive treatment helped slow progression of the disease, but did not lower their overall risk of dying of the disease.
The authors say this finding suggests that “more aggressive therapy can result in more harm than good” because the side effects of those treatments can be debilitating to patients, and may not pay off in the end.
Lead author of the study Professor Freddie Hamdy, from the Nuffield Department of Surgical Sciences at the University of Oxford, described this as very good news. “It means more men can afford to delay aggressive treatments that might leave them with lasting side effects, as long as they are carefully monitored for changes in their condition.”
It’s also clear, he added, “that, unlike many other cancers, a diagnosis of prostate cancer should not be a cause for panic or rushed decision making”.
That kind of monitoring is already offered to low-risk prostate cancer patients in the UK and US, but this study suggests that it “can be extended safely to intermediate-risk disease”, he added. It could provide some hope to people affected by prostate cancer – the fourth-most prevalent type of cancer worldwide.
As part of the study, more than 80 000 men aged 50 to 69 were screened for prostate cancer between 1999 and 2009. More than 2 600 were diagnosed with the disease, and 1 643 were enrolled in the trial.
They were at low or intermediate risk from their disease, and the authors stressed that their findings do not apply to men at high risk. “High-risk patients need quick and aggressive treatments,” Hamdy said.
The researchers split the men in the cohort into three groups that were monitored over time or treated with radiotherapy or prostatectomy, a surgical procedure to remove all or parts of a patient’s prostate. The goal was to measure and compare the effectiveness of each treatment.
At a median of 15 years post-diagnosis, they had a follow-up. Fewer than 3% had died of prostate cancer, and the odds were similar for each treatment group. For example, 3.1% of the deaths came among men in the active-monitoring group, while 2.9% were among men who received radiotherapy.
Without treatment, men in the active-monitoring group were nearly twice as likely to see their prostate cancer progress and spread – or form what’s known as metastases – than the men in the aggressive treatment groups. But that progression didn’t lead to a higher likelihood of death.
This surprised the researchers, said Hamdy, and suggests that “if men develop metastases, that doesn’t necessarily mean they will die of prostate cancer” – though they may die of other causes.
Because prostate cancers typically progress slowly, even if the cancer evolves more quickly under active monitoring, the study’s finding suggests that the long-term deleterious effects of harsh treatment may not be worth it.
Active monitoring, also known as active surveillance, is already used for many low-risk men. It doesn’t mean “doing nothing,” Hamdy said.
Patients under active monitoring are tested regularly by a clinician for “any hint that the disease is progressing.” If the cancer is progressing, then the patient may need surgery, radiation or hormone therapy. In the study, most men in the active-monitoring group eventually received some form of more aggressive treatment”.
In a separate paper, published in the same journal, the researchers revealed that many men who undergo aggressive treatments report negative side effects that can last up to 12 years. These include urinary leakage and erectile dysfunction, which is why it’s important for patients to consider these effects against the likely benefits of the treatments.
Study details
Fifteen-Year Outcomes after Monitoring, Surgery, or Radiotherapy for Prostate Cancer
Freddie Hamdy, Jenny Donovan, Athene Lane, Andrew Doble et al., for the ProtecT Study Group
Published in the NEJM on 11 March 2023
Abstract
Background
Between 1999 and 2009 in the United Kingdom, 82,429 men between 50 and 69 years of age received a prostate-specific antigen (PSA) test. Localised prostate cancer was diagnosed in 2664 men. Of these men, 1643 were enrolled in a trial to evaluate the effectiveness of treatments, with 545 randomly assigned to receive active monitoring, 553 to undergo prostatectomy, and 545 to undergo radiotherapy.
Methods
At a median follow-up of 15 years (range, 11 to 21), we compared the results in this population with respect to death from prostate cancer (the primary outcome) and death from any cause, metastases, disease progression, and initiation of long-term androgen-deprivation therapy (secondary outcomes).
Results
Follow-up was complete for 1610 patients (98%). A risk-stratification analysis showed that more than one third of the men had intermediate or high-risk disease at diagnosis. Death from prostate cancer occurred in 45 men (2.7%): 17 (3.1%) in the active-monitoring group, 12 (2.2%) in the prostatectomy group, and 16 (2.9%) in the radiotherapy group (P=0.53 for the overall comparison). Death from any cause occurred in 356 men (21.7%), with similar numbers in all three groups. Metastases developed in 51 men (9.4%) in the active-monitoring group, in 26 (4.7%) in the prostatectomy group, and in 27 (5.0%) in the radiotherapy group. Long-term androgen-deprivation therapy was initiated in 69 men (12.7%), 40 (7.2%), and 42 (7.7%), respectively; clinical progression occurred in 141 men (25.9%), 58 (10.5%), and 60 (11.0%), respectively. In the active-monitoring group, 133 men (24.4%) were alive without any prostate cancer treatment at the end of follow-up. No differential effects on cancer-specific mortality were noted in relation to the baseline PSA level, tumor stage or grade, or risk-stratification score. No treatment complications were reported after the 10-year analysis.
Conclusions
After 15 years of follow-up, prostate cancer–specific mortality was low regardless of the treatment assigned. Thus, the choice of therapy involves weighing trade-offs between benefits and harms associated with treatments for localized prostate cancer.
NEJM article – Localised prostate cancer – then and now (Open access)
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