Novel Urine Biomarker Test May Reduce Unnecessary Cystoscopies in Patients With Bladder Cancer

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Researchers have found that a novel urine biomarker test may effectively halve the number of cystoscopies necessary in high-risk patients with bladder cancer, according to recent findings presented by Dreyer et al at the European Association of Urology (EAU) Congress 2024. The research also indicated there may be no increased risk of recurrence in patients who underwent a urine biomarker test rather than a standard flexible cystoscopy.


“We know that many patients really dread their cystoscopy appointments but are prepared to go through with them because they want to be sure they are free of the cancer,” stressed study author Thomas Dreyer, MD, PhD, a researcher at the Bladder Cancer Research Team in the Department of Urology at Aarhus University Hospital. “However, if given the option of providing a urine sample instead of undergoing an uncomfortable medical procedure, most would choose that, so long as they were confident it was just as effective,” he added.

High-risk patients with the most aggressive type of bladder cancer have a 60% to 70% likelihood of cancer recurrence within 5 years after surgery, which is why postsurgical follow-up among these patients is often intensive. For instance, in Denmark, recommendations call for cystoscopies every 4 months for 2 years. In the United Kingdom, patients undergo more frequent cystoscopies: every 3 months for 2 years.

The recent study—one of the first to explore the efficacy of the novel urine biomarker test called Xpert Bladder Cancer Monitor in high-risk bladder cancer—allowed researchers to assess whether the test could reduce the number of cystoscopies patients were required to undergo as well as detect signs of cancer recurrence. Previous studies have only assessed biomarker tests observationally in addition to the existing standard of care.

“There have been lots of studies of urine biomarker tests showing positive results but no randomized trial to show what the impact would actually be in the clinic. We were confident the test was sensitive enough to not provide false-negatives that put patients at risk, [b]ut would it provide false-positives and actually result in equal or even higher numbers of cystoscopies being carried out? Our findings show that wasn’t the case,” explained Dr. Dreyer

Study Methods and Results

The researchers randomly assigned 313 high-risk patients with bladder cancer to undergo either the standard three cystoscopies per year or one cystoscopy followed by two urine biomarker tests per year. The novel urine biomarker test was designed to monitor for bladder cancer recurrence by measuring levels of five target mRNAs.

The researchers noted the patients who received positive results were called into the hospital for a cystoscopy to check for evidence of cancer recurrence. The urologists performing the cystoscopies were aware of the positive results.

After 2 years, 44% of the follow-up appointments among patients in the urine biomarker test group involved a cystoscopy compared with nearly 100% among those in the standard-treatment group.

Additionally, the researchers found evidence that the urine biomarker tests were capable of detecting cancer recurrence before any disease was visible through the cystoscopy. Among more than 50% of the patients who had false-positive test results, there was evidence of cancer recurrence at a later appointment.


“We know as urologists, we carry out too many cystoscopies, particularly during follow-up of patients with non–muscle-invasive bladder cancer, so we need to find alternatives. Bladder cancer is a disease that particularly affects the elderly, and we foresee an increasing number of patients due to the aging population, which could impact on the numbers able to access care,” underscored Joost Boormans, MD, PhD, Professor of Urology at the Erasmus University Medical Centre, the Netherlands, and a member of the EAU Scientific Congress Office. “This trial shows us a possible means of reducing cystoscopies. If the final results later this year do confirm that the urine [biomarker] test can pick up cancer recurrence as effectively as cystoscopies, then this is something we need to look at introducing into clinical practice as soon as possible—because it reduces demand on our resources and helps to make health care more accessible,” he concluded.

Disclosure: The research in this trial was funded by Cepheid.

The content in this post has not been reviewed by the American Society of Clinical Oncology, Inc. (ASCO®) and does not necessarily reflect the ideas and opinions of ASCO®.