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August 23, 2023
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Data confirm safety of active surveillance among patients with low-risk prostate cancer

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Key takeaways:

  • Men with low-risk prostate cancer may be safely followed with active surveillance only.
  • Certain men with favorable intermediate-risk disease may be actively watched with surveillance only.

Prostate cancer is a complex cancer, with patients who present differently with various clinical staging and criteria; thus, follow-up care after treatment also differs among this patient population.

“Generally, different criteria have been established to risk-stratify patients, and follow-up depends on the treatment that patients receive,” Bashir Al Hussein Al Awamlh, MD, a urologic fellow at Vanderbilt University Medical Center, told Healio. “For the more standard definitive treatments, we typically follow up with PSA testing every 6 to 12 months. After treatment, we expect PSA levels to go to a certain level after surgery, and levels are supposed to go to undetectable levels after radiation treatment. If PSA levels increase, we then add on imaging tests to ensure that the cancer has not recurred or spread elsewhere.”

Al Awamlh pullquote

Risk stratification

Risk stratification is an area that continues to evolve, according to Al Hussein Al Awamlh.

In the ProtecT study, researchers sought to assess and compare outcomes among 1,643 U.K. men diagnosed with localized prostate cancer randomly assigned to either active monitoring (n = 545), prostatectomy (n = 553) or radiotherapy (n = 545).

They compared the results with respect to death from prostate cancer and death from any cause, metastases, disease progression, and initiation of long-term androgen-deprivation therapy. Median follow-up was 15 years.

Results showed that more than one-third of men had intermediate or high-risk disease at diagnosis. Prostate cancer-associated mortality occurred in 2.7%, of which 3.1% occurred among those in the active-monitoring group, 2.2% in the prostatectomy group and 2.9% in the radiotherapy group (P = .53, for the overall comparison).

Moreover, 51 men (9.4%) in the active-monitoring group developed metastases, followed by 5% in the radiotherapy group and 4.7% in the prostatectomy group. Nearly one-fourth (24.4%) of men assigned active-monitoring were alive without any treatment by the end of study follow-up.

“These are the general statistics that we quote patients,” Al Hussein Al Awamlh said. “It’s hard to predict exactly what each patient has because the disease presents with different modalities. We have certain algorithms or ‘risk calculators’ that we use that give us predictions for what the recurrence may be depending on these algorithms. The rationale is that active surveillance limits the harms of immediate therapy associated with radiation and surgery, including side effects of sexual function, urinary function and bowel function, by safely monitoring the cancer. There are a lot of studies that have shown that active surveillance is safe and more studies continue to show this.”

Active surveillance

In a study published in JAMA Internal Medicine in April, Al Hussein Al Awamlh and colleagues found that the use of active surveillance for low-risk and favorable intermediate-risk prostate cancer greatly increased in the U.S. between 2010 and 2018.

As Healio previously reported, nearly 60% of U.S. men with low-risk disease chose active surveillance in 2018 vs. only 16.4% of men in 2010.

“We undertook this study because we needed an update at the national level on how we are managing men with low-risk prostate cancer and whether men are receiving active surveillance as we hoped,” Al Hussein Al Awamlh said. “We found that active surveillance was the most popular treatment choice, which is a great thing, and we are headed in the right direction, but we ultimately will like to see active surveillance adopted on a higher level. The goal is to have between 80% and 85% of men with low-risk prostate cancer undergoing active surveillance.”

Results additionally showed that the rate of active surveillance increased from 7.8% in 2010 to 21.8% in 2018 among men with intermediate-risk disease.

“That finding was a bit of a surprise — a good and pleasant surprise — and we realized that urologists, radiation oncologists and other treating physicians now understand that there is a subset of patients that are classified as favorable intermediate-risk, which has features that are more aligned with low-risk disease and can be actively watched,” Al Hussein Al Awamlh said.

However, he said it is important to note that active surveillance does not necessarily mean that men won’t be required to undergo treatment.

“When we counsel these patients, we tell them that during a 10-year period, studies have shown that almost 50% of men will eventually undergo treatment, but for some time men are able to live a great quality of life without receiving any treatment,” he said.

In development

There are many nuances of prostate cancer and a surplus of exciting research is underway in this area, according to Al Hussein Al Awamlh.

“One of my mentors has always said that prostate cancer is an art — both in terms of treating it and understanding it,” he said. “One area in need of research that my colleagues and I came across in our research is with disparities in care and specifically in receipt of active surveillance related to race, ethnicity and income. Research is always needed in that area to identify modifiable factors where we can intervene to limit these disparities.”

He said another area of research involves examining how health literacy is associated with patients choosing active surveillance.

“There is definitely a need for further exploration in this area. More health education is needed to ensure that patients feel comfortable being followed with active surveillance,” Al Hussein Al Awamlh said. “One of the reasons that men tend to shy away from active surveillance is the anxiety and burden of living with cancer. Studies have shown that certain interventions, such as support groups and exercise, can be added to the regimen for men so that their anxiety levels are more controlled. I look forward to seeing more of this type of research.”

Other research is underway looking at incorporating MRI into active surveillance at baseline, he added.

“Men are being prospectively followed in that area and it will be interesting to see how these studies turn out,” Al Hussein Al Awamlh said. “Another interesting domain is biomarkers in the prostate cancer space. Biomarkers are essentially molecules that provide additional information on the diagnosis or prognosis of the disease that help us predict response to treatment. It will be interesting to see how we can use biomarkers to further stratify men to safely monitor or deliver treatment if needed, and maybe mitigate the harms of frequent prostate biopsies and additional tests.”

Other research in Europe is incorporating prostate-specific membrane antigen (PSMA) into PET scans to better detect disease, Al Hussein Al Awamlh said.

“This has historically been used in different stages of prostate cancer, mainly to detect metastatic disease or the burden of disease at diagnosis,” he said. “But there are studies that incorporate PSMA into initial risk stratification to target cancer in the very beginning in the prostate itself. It will be interesting to see how this technological advance plays out with active surveillance. Artificial Intelligence is another big thing in prostate cancer, cancer care and health care in general.

“Bottom line,” Al Hussein Al Awamlh added, “active surveillance is a great way to manage certain patients with prostate cancer as it mitigates the harms of treatments while remaining safe from an oncologic standpoint.”

References:

For more information:

Bashir Al Hussein Al Awamlh, MD, of Vanderbilt University Medical Center, can be reached at bashir.alhussein@vumc.org.