Prostate cancer is one of the most common cancers affecting men in the United States, and it comes with a heavy price tag. Nearly 300,000 men are expected to be diagnosed this year, and treatment costs can range from around $15,000 for active surveillance to well over $100,000 for surgery, radiation, or advanced drug therapies.
Those numbers only tell part of the story. The bigger challenge for many men is deciding what to do after a diagnosis. Some will benefit from starting aggressive treatment right away. Others can safely watch and wait, avoiding years of side effects and expenses. Making the wrong choice can mean unnecessary medical bills, a lower quality of life, or missing the best window for treatment.
This month, a new tool entered the picture that could make those decisions a little clearer.
A First for Prostate Cancer Care
The Food and Drug Administration has given De Novo marketing authorization to ArteraAI Prostate — the first digital pathology software powered by artificial intelligence that can predict long-term outcomes for men with non-metastatic prostate cancer.
Developed by California-based Artera, the software reviews digitized biopsy images to measure how aggressive the cancer is and determine which treatment is likely to help. With this approval, qualified pathology labs can start using this AI tool at the time of diagnosis, rather than sending samples out and waiting weeks for results.
“This is a defining moment for AI in cancer care,” said Andre Esteva, Artera’s chief executive and co-founder. “Better data means smarter treatment choices, and that’s not just a clinical benefit — it’s a financial one for patients and the healthcare system.”
Why the Right Call Matters for Costs and Care
Cancer care in the U.S. costs more than $200 billion a year, according to the National Cancer Institute. In prostate cancer specifically, overtreatment can mean tens of thousands of dollars in expenses and life-changing side effects, such as incontinence or sexual dysfunction. Undertreatment, on the other hand, can result in the cancer spreading and require more complex — and more expensive — interventions later.
Studies suggest that as many as half of prostate cancer patients could be safely monitored through active surveillance rather than undergoing surgery or radiation. The challenge has always been knowing who can wait and who can’t.
“This software allows us to deliver personalized insights faster, improve workflow efficiency, and maintain quality at scale,” said Dr. Adam Cole, founder and chief scientific officer of TruCore Pathology Group. “That can make a real difference in matching the right patient to the right care at the right time.”
A Rare FDA Approval
The FDA’s De Novo pathway is reserved for medical devices unlike anything currently on the market. ArteraAI Prostate had previously received Breakthrough Device Designation, which speeds up the review process for technology that could significantly improve care.
While this approval applies to the medical device software, Artera has already been offering the same AI capabilities through its laboratory-developed test in the U.S. and overseas. The company says the underlying platform has been tested in multiple Phase 3 trials and is being adapted for use in breast and other cancers.
What This Means for Patients
For men facing a prostate cancer diagnosis, the potential benefits are straightforward:
- Avoiding unnecessary costs by steering low-risk patients away from treatments and their side effects that they don’t need
- Preventing metastasis and death by making sure high-risk patients get timely care and avoid complex interventions down the road caused by the cancer spreading
The tool also offers something more complex to measure — peace of mind. Making a treatment decision with more data, rather than relying solely on general guidelines or waiting weeks or months for additional tests, could help patients feel more confident about their path forward.
The broader hope is that as tools like ArteraAI Prostate become more widely available, they can help reduce the financial and emotional toll of prostate cancer, while making sure resources are used where they’re needed most.
Key Facts:
- Nearly 300,000 new U.S. prostate cancer cases expected in 2025.
- Treatment costs range from $15,000 to $100,000+, depending on the approach.
- $200 billion: Annual U.S. cancer-related medical spending.
- Up to 50% of prostate cancer patients may be eligible for active surveillance.
- Global AI in healthcare market is projected to reach $188 billion by 2030.
Featured Image Credit: Photo by Leeloo The First; Pexels
