Active monitoring of prostate cancer has the same high survival rates after 15 years as radiotherapy or surgery, reports the largest study of its kind today.
The latest findings from the ProtecT trial, led by the Universities of Oxford and Bristol, are presented today at the European Association of Urology (EAU) Congress in Milan and published in the New England Journal of Medicine.
The trial was funded by the National Institute for Health and Care Research (NIHR).
Although men on active monitoring – which involves regular tests to check on the cancer – were more likely to see it progress or spread than those receiving radiotherapy or surgery, this didn’t reduce their likelihood of survival.
The trial also found that the negative impacts of radiotherapy and surgery on urinary and sexual function persist much longer than previously thought – for up to 12 years.
The findings show that treatment decisions following diagnosis for low and intermediate risk localized prostate cancer do not need to be rushed, according to lead investigator, Professor Freddie Hamdy from the University of Oxford.
It’s clear that, unlike many other cancers, a diagnosis of prostate cancer should not be a cause for panic or rushed decision making. Patients and clinicians can and should take their time to weigh up the benefits and possible harms of different treatments in the knowledge that this will not adversely affect their survival.”
Professor Freddie Hamdy, University of Oxford
The trial was conducted in nine UK centers and is the longest running study of its kind. It is the first to fully evaluate three major treatment options: active monitoring, surgery (radical prostatectomy) and radiotherapy with hormones for men with localised prostate cancer.
Between 1999 and 2009, 1,643 men aged 50-69 years across the UK, who were diagnosed with localized prostate cancer after a PSA blood test, agreed to be randomized to active monitoring (545), radical prostatectomy (553) or radical radiotherapy (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.
They found that around 97% of the men diagnosed with prostate cancer survived 15 years after diagnosis, irrespective of which treatment they received. Around a quarter of the men on active monitoring had still not had 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. But the negative effects of surgery or radiotherapy on urinary, bowel and sexual function were found to persist much longer than previously thought.
In earlier findings released in 2016, the researchers found that, after ten years follow up, men whose cancer was being actively monitored were twice as likely to see it progress or metastasize than those in the other groups. The assumption had been that this might lead to a lower survival rate for men on active monitoring over a longer time period. However, the results from the 15-year follow-up show that this isn’t the case and that survival rates remain similarly high across all groups.
Professor Freddie Hamdy said: “This is very good news. Most men with localized 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, so a quick decision for treatment is not necessary and could cause harm.”
“It’s also now clear that a small group of men with aggressive disease are unable to benefit from any of the current treatments, however early these are given. We need to both improve our ability to identify these cases and our ability to treat them.”
Co-investigator, Professor Jenny Donovan, from the University of Bristol, said: “Patients and doctors now have the necessary information on the long-lasting side effects of treatments to better understand the trade-offs between their benefits and harms. Survival no longer needs to be considered when deciding on treatment – as that’s the same for all three options. Now men diagnosed with localised prostate cancer can use their own values and priorities when making the difficult decisions about which treatment to choose.”
The trial has also highlighted flaws in current methods to predict which prostate cancers are likely to grow quickly and spread. Initially, all those recruited to the trial were diagnosed with localized cancer and 77% of them were deemed low risk. A reassessment using more modern methods showed that a far greater number would now be considered intermediate-risk – and in around 30% of men, the disease had spread beyond the prostate already. This means that the participants in the study had higher grade and stage disease than was thought initially. Despite this finding, mortality was still low, even when men with intermediate disease delayed or did not have radical treatment. Some of the men who subsequently died of their prostate cancer had been assessed as low risk at diagnosis, which the researchers highlight as an issue of concern.
Professor Peter Albers, chair of the EAU’s Scientific Congress Office and a urologist at Düsseldorf University, said: “The fact that the greater progression of disease seen under active monitoring didn’t translate into higher mortality will be both surprising and encouraging to urologists and patients. Active monitoring and biopsy protocols today are much more advanced than at the time this trial was conducted, so it’s possible we could improve on these outcomes still further. It’s an important message for patients that delaying treatment is safe, especially as that means delaying side effects as well.”
“But it’s also clear that we still don’t know enough about the biology of this disease to determine which cancers will be the most aggressive and more research on this is urgently needed.”
Hamdy, F.C., et al. (2023) 15-year outcomes after monitoring, surgery, or radiotherapy for localized prostate cancer. New England Journal of Medicine.doi.org/10.1056/NEJMoa2214122.
Some Ontario doctors have started offering a free shot that can protect babies from respiratory syncytial virus while Quebec will begin its immunization program next month.
The new shot called Nirsevimab gives babies antibodies that provide passive immunity to RSV, a major cause of serious lower respiratory tract infections for infants and seniors, which can cause bronchiolitis or pneumonia.
Ontario’s ministry of health says the shot is already available at some doctor’s offices in Ontario with the province’s remaining supply set to arrive by the end of the month.
Quebec will begin administering the shots on Nov. 4 to babies born in hospitals and delivery centers.
Parents in Quebec with babies under six months or those who are older but more vulnerable to infection can also book immunization appointments online.
The injection will be available in Nunavut and Yukon this fall and winter, though administration start dates have not yet been announced.
This report by The Canadian Press was first published Oct. 21, 2024.
-With files from Nicole Ireland
Canadian Press health coverage receives support through a partnership with the Canadian Medical Association. CP is solely responsible for this content.
ISLAMABAD (AP) — Polio cases are rising ahead of a new vaccination campaign in Pakistan, where violence targeting health workers and the police protecting them has hampered years of efforts toward making the country polio-free.
Since January, health officials have confirmed 39 new polio cases in Pakistan, compared to only six last year, said Anwarul Haq of the National Emergency Operation Center for Polio Eradication.
The new nationwide drive starts Oct. 28 with the aim to vaccinate at least 32 million children. “The whole purpose of these campaigns is to achieve the target of making Pakistan a polio-free state,” he said.
Pakistan regularly launches campaigns against polio despite attacks on the workers and police assigned to the inoculation drives. Militants falsely claim the vaccination campaigns are a Western conspiracy to sterilize children.
Most of the new polio cases were reported in the southwestern Balochistan and southern Sindh province, following by Khyber Pakhtunkhwa province and eastern Punjab province.
The locations are worrying authorities since previous cases were from the restive northwest bordering Afghanistan, where the Taliban government in September suddenly stopped a door-to-door vaccination campaign.
Afghanistan and Pakistan are the two countries in which the spread of the potentially fatal, paralyzing disease has never been stopped. Authorities in Pakistan have said that the Taliban’s decision will have major repercussions beyond the Afghan border, as people from both sides frequently travel to each other’s country.
The World Health Organization has confirmed 18 polio cases in Afghanistan this year, all but two in the south of the country. That’s up from six cases in 2023. Afghanistan used a house-to-house vaccination strategy this June for the first time in five years, a tactic that helped to reach the majority of children targeted, according to WHO.
Health officials in Pakistan say they want the both sides to conduct anti-polio drives simultaneously.
WASHINGTON (AP) — Millions of people with private health insurance would be able to pick up over-the-counter methods like condoms, the “morning after” pill and birth control pills for free under a new rule the White House proposed on Monday.
Right now, health insurers must cover the cost of prescribed contraception, including prescription birth control or even condoms that doctors have issued a prescription for. But the new rule would expand that coverage, allowing millions of people on private health insurance to pick up free condoms, birth control pills, or “morning after” pills from local storefronts without a prescription.
The proposal comes days before Election Day, as Vice President Kamala Harris affixes her presidential campaign to a promise of expanding women’s health care access in the wake of the U.S. Supreme Court’s decision to undo nationwide abortion rights two years ago. Harris has sought to craft a distinct contrast from her Republican challenger, Donald Trump, who appointed some of the judges who issued that ruling.
“The proposed rule we announce today would expand access to birth control at no additional cost for millions of consumers,” Health and Human Services Secretary Xavier Becerra said in a statement. “Bottom line: women should have control over their personal health care decisions. And issuers and providers have an obligation to comply with the law.”
The emergency contraceptives that people on private insurance would be able to access without costs include levonorgestrel, a pill that needs to be taken immediately after sex to prevent pregnancy and is more commonly known by the brand name “Plan B.”
Without a doctor’s prescription, women may pay as much as $50 for a pack of the pills. And women who delay buying the medication in order to get a doctor’s prescription could jeopardize the pill’s effectiveness, since it is most likely to prevent a pregnancy within 72 hours after sex.
If implemented, the new rule would also require insurers to fully bear the cost of the once-a-day Opill, a new over-the-counter birth control pill that the U.S. Food and Drug Administration approved last year. A one-month supply of the pills costs $20.
Federal mandates for private health insurance to cover contraceptive care were first introduced with the Affordable Care Act, which required plans to pick up the cost of FDA-approved birth control that had been prescribed by a doctor as a preventative service.
The proposed rule would not impact those on Medicaid, the insurance program for the poorest Americans. States are largely left to design their own rules around Medicaid coverage for contraception, and few cover over-the-counter methods like Plan B or condoms.
