The hand-held device, currently a prototype, is designed to monitor prostate-specific antigen (PSA) levels. It works similarly to blood glucose meters: users mix a droplet of their blood into a vial of reactive liquid, and then place that mixture onto a testing strip. The strip is then inserted into the reader on the device. The device’s screen will show the user’s PSA level within minutes.
Soleymani and her fellow researchers recently published a study on their device earlier this month.
“We all see the improvement in care that glucose monitors have made for diabetic patients,” Leyla Soleymani, PhD, an associate professor of biomedical engineering at McMaster University and one of the device’s lead developers, tells Verywell.
“Why can’t we have things like that for monitoring cancer patients, or other chronic disease patients? That [idea] really motivated this work.”
What Is PSA?
PSA is a protein produced by both normal as well as cancerous cells of the prostate gland. A PSA test measures the level of PSA in someone’s blood, and is used to help detect early stage prostate cancer alongside other screening methods. For people living with prostate cancer, PSA tests are also a way to monitor the disease.
“Generally, levels of PSA that are high or increasing over time are a cause for concern,” Gerald Denis, the Shipley Prostate Cancer Research Professor at Boston University School of Medicine, tells Verywell.
For people who don’t have prostate cancer, their PSA levels are often under 4 nanograms per milliliter (ng/mL) of blood. PSA levels between 4 and 10 can be cause for concern, especially in older adults. There’s a range, of course, and there are factors that can contribute to a higher PSA level outside of cancer. These include age, an enlarged prostate, recent ejaculation, and certain medication, among other things.
For people with prostate cancer, their PSA level should go down with effective treatment, Denis says. How often PSA is monitored depends on the patient and their stage of cancer.
“After a radical prostatectomy, the PSA level should fall very low," Denis says. “Most clinicians pick a time point about four to six weeks after surgery for the first measurement, then every six to 12 months for five years, and annually after that to watch for recurrence. But there is significant variation from patient to patient, depending on other factors, and the clinician is best able to decide how to monitor the patient for warning signs.”
Is There a Benefit To Monitoring PSA Information in Real Time?
For patients who have recovered from prostate cancer, an at-home PSA monitoring tool could be very helpful, Soleymani says. Being able to easily test and track their levels is important for disease management.
“Frequent monitoring is important because you get to compare the PSA level to the baseline of that same patient, and it gives you more than one data point,” she says. “Multiple data points show you a trend, which can give you an early signal for disease recurrence.”
Another benefit to knowing PSA information in real-time is limiting the need for in-person clinic appointments, Denis says. Self-monitored information can be communicated to a healthcare provider so they’re informed of your status, too.
“This option might be very helpful for patients who live in isolated rural areas far from the nearest hospital or clinic, or who are frail or have other reasons that make it difficult to leave home,” he says. “In the COVID-19 era, an at-home test reduces risk of exposure to coronavirus from a clinic visit.”
There are some potential downsides to at-home PSA monitoring, however. Patients need to be trained on how to interpret their readings so the data does not induce panic, Soleymani says. What’s more, Denis says too much monitoring can “create a sense of anxiety, especially because most biological markers normally fluctuate with monthly, daily, and even hourly rhythms.”
It’s also important to remember that home-testing PSA devices should not replace regular doctor appointments or cancer screenings.
When Will the Device Be Available?
While currently a prototype, the device may be available soon. Soleymani and her colleagues’ device still needs to go through clinical trials and get regulatory approvals. It also needs to be scaled up to production.
“We’re trying to develop partnerships with investors and also diagnostic companies that can help us expedite this process,” she says.
Testing is important when it comes to at-home devices, Denis says, as they need to be evaluated for false positive and false negative rates. If a device is too sensitive it could lead to false positives, “and too few could cause an important change in cancer progression to be overlooked, or to replace a regularly scheduled clinic visit.”
But both Denis and Soleymani believe home-testing devices can significantly improve patient care. As technology advances, the goal is to make health care more accessible for everyone.
“Something like this will give improved health care to two groups that need it the most: the elderly and people in remote areas,” Soleymani says. “And, everybody else.”
