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AI laser probe for prostate cancer enters clinical trials
FDA says yes to the tests
AI software capable of mapping tumor tissue more accurately to help surgeons treat and shrink prostate cancer using a laser-powered needle will soon be tested in real patients during clinical trials.
The National Cancer Institute estimated that approximately 12.6 percent of men will be diagnosed with prostate cancer at some point in their life. The risk for developing the disease rises over time for men over the age of 50. It's one of the most curable forms of cancer, considering most cases are caught in the early stages due to regular screening tests.
Treatment for prostate cancer varies depending on the severity of the disease. Patients can undergo hormone therapy, chemotherapy, or surgery to remove tissue. Avenda Health, a medical startup founded in 2017, is developing a new type of treatment that is less invasive. The US Food and Drug Administration (FDA) granted an investigational device exemption (IDE) to the company's invention this week, meaning it can now be used in a clinical study.
Patients will need to have an MRI scan and a targeted fusion biopsy performed first. The data is processed by Avenda's AI algorithms in its iQuest software to map where the cancerous cells are located within the prostate. Next, the computer vision-aided model will simulate where best to insert FocalPoint, a probe armed with a laser, to help surgeons treat the patient's tumor. The heat from the laser gently heats the cancerous cells and kills them with goal of shrinking and removing the whole tumor.
MRI images where cancer is mapped using iQuest software before and after treatment. Image Credit: Avenda Health
"Historically, prostate cancer treatments of surgery or radiation impacts critical structures like the urethra and nerves which control sexual and urinary function," Avenda's CEO and co-founder Shyam Natarajan told The Register. "Our focal laser ablation system, FocalPoint, which is powered by our AI-driven cancer margin software, iQuest, specifically targets tumor tissue and avoids healthy tissue. This means patients no longer lose control over these functions that are so common with traditional treatments, so quality of life is significantly improved."
The treatment is only effective for men diagnosed with intermediate risk of prostate cancer, a classification that describes tumors being confined within the prostate only. Patients are considered high risk in cases where the cancer has spread beyond the prostate.
"This is one of the benefits of the iQuest software. Not only can it map the cancer, but it also provides decision support for the physician as they determine the best course of treatment for an individual patient. Not every patient is going to be eligible for focal therapy, and it is important for the physician to distinguish between good focal therapy candidates and not. iQuest provides useful insights for that decision making process," Natarajan said.
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Avenda received FDA clearance for its FocalPoint device in 2020. The IDE approval brings the company one step closer to bringing their product to market after clinical trial testing, Brittany Berry-Pusey, co-founder and COO of Avenda, said in a statement.
"This clinical trial will play a key role in advancing our breakthrough technology to improve prostate cancer care. With no new FDA approvals for the treatment of localized prostate cancer in more than four decades, we look forward to working alongside our clinical sites to collect the data necessary to bring iQuest and FocalPoint to market and into the patient care environment."
Natarajan told us the company was aiming to begin clinical trials in 2023. ®