FDA approves new prostate cancer screening tool, drug manufacturer says

This method will not replace traditional blood tests, but may help guide physicians when the cancer is spreading.

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The Food and Drug Administration has approved a new photographic agent that will detect prostate cancer after it has spread to other parts of the body, the company that made the agent on Thursday.

Experts say the tracer, developed by medical imaging company Lantheus, will provide doctors with the most practical help leading them to metastatic cervical cancer cells that were hard to detect before this.

Cervical cancer is the second leading cause of cancer in men in the United States, after lung cancer, according to the American Cancer Society. More than 34,000 men die from the disease each year.

When prostate cancer spreads, it often enters the bones, says Dr. Michael Morris, medical cancer doctor at the Memorial Sloan Kettering Cancer Center in New York City. That makes it difficult to find and apply traditional thinking techniques.

"It's very difficult to take pictures of what's going on inside the bones," Morris said, adding that traditional scans often find problems in the tissues around the bones, after the damage has been done.

"Now we don't have to wait for that," said Morris, who was involved in the follow-up clinical trial. "We can see it more clearly and earlier than ever before."

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This new process utilizes a sequential molecule that seeks the protein found in many prostate cancer cells called prostate-specific membrane antigen, or PSMA. The tracer, injected into the bloodstream, illuminates those cells during a PET scan.

The same tracking agent, also seeking PSMA, was approved by the FDA in December for use in two California hospitals: the University of California, Los Angeles and the University of California, San Francisco. Institutions have been researching this type of technology since 2015.

"We have been using it for many years and it works well," said Dr. Thomas Hope, director of molecular medicine at UCSF's Department of Radiation and Biomedical Imaging. "We can see where the disease is now and people are getting radiation directed at them."

"It redefines the way we think about bladder cancer," he said.

The new authorization will be the first to track high-quality cervical cancer that is commercially available nationwide.

The scan is not intended to replace the PSA test, a common bladder cancer screening tool. PSA represents a prostate-specific antigen, a protein found in the blood. Instead, it is designed for men who are already diagnosed with the disease.

Scanning can be very helpful for patients with cervical cancer who have increased PSA levels after receiving treatment, including surgery and radiation, says Dr. Xiao Wei, a cancer specialist at the Dana-Farber Cancer Institute in Boston. An increase in PSA levels may indicate that the cancer has spread elsewhere in the body.

While Wei and other cervical cancer specialists agree that the model will provide them with more information about metastatic cancer, it is still unclear what they should do with this information.

"The next big question is, does it have an impact on what we do for the patient? Will that help us improve outcomes?" said Dr. Justin Gregg, an assistant professor in the field of urology and health inequality at MD Anderson Cancer Center in Houston.

Treatment for prostate cancer is usually done on its own, depending on the age of the man, any other dangerous substances he may have or how aggressive the cells look under a microscope. Treatment, which may include radiation and bladder removal, can have serious side effects, including impotence and immunity.

And not all metastatic prostate cancer will threaten a man's health.

"We can get deposits, but for a 75- or 85-year-old, they can stay there without needing emergency treatment," said Dr. Derek Raghavan, president of the Levine Cancer Institute in Charlotte, North Carolina. "There is also prostate cancer that can be malignant and can actually harm a patient for several years."

The new image could not determine which types of prostate cancer cells could be the most dangerous, Raghavan said.

"I think that as they develop technology," he said, "they will develop a more sophisticated way to identify those who have the potential to grow faster."