AI-Assisted Prostate Cancer Treatment Is Near

Living in the San Francisco Bay area, where you can't avoid conversations about tech even if you try (and believe me, people do), I hear all the time, with Paul Revere-like urgency: "The robots are coming!" Any development in artificial intelligence (AI) or machine learning (ML) inevitably spawns thousands of LinkedIn posts, Medium articles and good, old-fashioned watercooler conversations about how the automatonic revolution is just one push of a button away.

So when you hear about a new device that uses AI to treat prostate cancer, it's understandable why you might begin to picture scrubs-clad robots walking into the operating room. For now, that image is still science fiction, but that doesn't mean AI-assisted prostate cancer treatment isn't a promising new development.

How the new treatment works

Unlike other cancers, prostate cancer often requires treatment of the entire organ—not just the cancerous areas.

"An issue [with prostate cancer] has been our inability to really reliably identify lesions that could be harmful to the patient via imaging," explained Ganesh Palapattu, M.D., chief of urologic oncology at Michigan Medicine, the University of Michigan's health system.

As a result, doctors have to either treat or remove the entire prostate, a walnut-shaped gland that sits below the bladder and in front of the rectum. The prostate produces fluid that forms part of semen, which transports sperm.

"When you have a brain tumor, you don't take out the whole brain. When you have lung cancer, you don't take out the whole lung. With prostate cancer, we do," Palapattu said.

And there are significant drawbacks to that approach.

"There are two major ways to treat prostate cancer: one is surgical removal, the other is radiation therapy...In general, radiation and surgery are thought to be equal in their ability to cure the disease, but each has different side effects," Palapattu explained. "All treatments for prostate cancer today have some impact on urinary function and sexual function."

What's different with the latest AI-driven device, called the Avenda Health Focal Therapy System, is that it targets only the tumor. Shyam Natarajan, CEO of Avenda Health in Santa Monica, California, likened the process to a lumpectomy procedure for breast cancer.

"Our AI platform was developed with a large database of cancer imaging and pathology, which is used in conjunction with a patient's own clinical information to create a cancer probability map to calculate precisely where treatment should be applied," Natarajan said in an email exchange.

After identifying the problem areas, urologists treat them with a process called laser ablation. This approach—treating the affected areas rather than the whole organ—is called focal therapy.

"Our goal is to preserve as much healthy tissue as possible, thus minimizing the side effects of treatment for the patient," Natarajan said.

What the medical community thinks

Palapattu and S. Adam Ramin, M.D., a fellow urologist in Los Angeles, expressed cautious optimism about the new treatment.

"I think the development is intriguing," Palapattu said. "In many ways, it represents what I believe will be the future of prostate cancer therapy, which is focal treatment."

Ramin, medical director of Urology Cancer Specialists, largely agreed.

"Overall, it seems very promising," Ramin said. "It does align with some of the other types of focal therapies that are available right now...the advantage of this one is that it may be able to be done in the office without the patient being under anesthesia and without struggling to have multiple specialists involved in a particular procedure."

He added, however, that there could be a potential downside.

"One of the major issues that I would be concerned about is how well the technology protects against possible injury to adjacent organs, especially the rectum," Ramin said. "If there is thermal injury, a perforation could potentially develop in the rectum. And then a person can develop a tunnel between the urinary tract and the colonic tract, called a fistula, which would need more surgery."

Avenda, through its press relations office, stated the system "uses a proprietary optical laser and thermal sensor" to avoid damaging healthy tissue.

Data from a study of 10 patients indicate that the device is safe, with no decline in urinary or sexual function observed in the patients over a follow-up period, according to a May 2021 announcement from Avenda.

Of course, until it has been tested more widely over a number of years, the long-term efficacy and side effects will not be known.

When it will be available

The Avenda Health Focal Therapy System has received a "breakthrough device" designation from the Food and Drug Administration (FDA), which expedites the review process, but it hasn't yet been approved, so don't expect to find it on your next visit to the doctor's office.

"Generally, you need high numbers of patients to be followed for about 10 years" before you can truly determine whether a particular treatment works on prostate cancer, Ramin said. But other factors will determine whether it becomes widely adopted.

"Success also has to do with whether it can be brought to clinical practice, meaning it's able to be done at the office with reasonable comfort and reasonable costs," Ramin added. "These machines with AI are going to cost a lot of money, and if the reimbursement for the treatment does not correlate well with the cost, then urologists will not adopt the technology in their office."

Avenda seems up to the challenge.

"We will work closely with the FDA to bring our product to market so that patients no longer need to choose between treating their prostate cancer and preserving their quality of life," said Brit Berry-Pusey, co-founder and COO of Avenda Health, also in an email conversation.

She noted that "initial studies have shown success in our AI algorithm to identify the appropriate cancer margins" and pointed to a recent study that indicated focal therapy has the same oncological outcomes for low-intermediate-risk prostate cancer patients as prostate removal.

"We look forward to launching our own pivotal, randomized, controlled, multicenter clinical trial specifically of the Avenda Health's Focal Therapy System to support our submission to the FDA for approval," Berry-Pusey added.

And the medical community seems to be rooting for the device.

"We need to have larger-scale studies to really put it through its paces," Palapattu said. "But it seems like a step in the right direction for sure."

It may even lead to breakthroughs beyond the use of AI in diagnostics and imaging.

"[AI] might eventually play some role in our electronic medical record to suggest potential differential diagnoses or testing," Palapattu said.

But, unfortunately for futurists, he thinks artificially intelligent robotic surgeons are still just a pipe dream.

"There's no way AI would be used to perform surgery" anytime soon, Palapattu said. "There are just too many unknowns."