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FDA Approves Injectable Radiation Treatment for Hormone-sensitive Prostate Cancer

The Food and Drug Administration (FDA) approved Pluvicto (lutetium Lu-177 vipivotide tetraxetan) in combination with an androgen receptor pathway inhibitor (ARPI) to treat some people with metastatic hormone-sensitive prostate cancer, the agency announced July 31. This radioligand therapy travels through the bloodstream, binds to prostate-specific membrane antigens (PSMA) on prostate cancer cells and delivers radiation directly to those cells. The FDA initially approved the injectable targeted radiation therapy in 2022 for people with metastatic PSMA-positive prostate cancer that had progressed after hormone therapy and chemotherapy. The FDA based the new approval on results of a phase III clinical trial, which were published Aug. 6, 2026, in the Lancet. The study included 1,144 people with metastatic prostate cancer who received an ARPI either with or without Pluvicto, Oncology News Central reported. After a median follow-up of 23.6 months, people receiving Pluvicto had a 28% lower risk of radiographic progression or death than those receiving an ARPI alone. “The treatment landscape for [metastatic hormone-sensitive prostate cancer] is evolving, and this approval reflects a growing recognition that earlier treatment intensification matters,” Michael Morris, a study author and genitourinary medical oncologist at Memorial Sloan Kettering Cancer Center in New York City, said in a news release.

Researchers Test Vaccines for People With Lynch Syndrome

Lynch syndrome is an inherited condition caused by certain variants in genes that normally repair mistakes in DNA. These variants are associated with an increased risk for several cancers, with colon cancer being the most common. Some genetic variants that cause Lynch syndrome carry as high as an 80% lifetime risk of colon cancer, compared with a 5% risk in the average person, the Associated Press reported. Clinical trials are currently exploring the use of at least three vaccines to see if they can prevent colon cancer in people with Lynch syndrome by teaching the immune system to recognize abnormalities in precancerous cells before they develop into cancer. Growths caused by Lynch syndrome “tend to accumulate hundreds of mutations that are going to generate proteins that are novel, not made by our normal cells,” Eduardo Vilar-Sanchez, a medical oncologist at the University of Texas MD Anderson Cancer Center in Houston, told the Associated Press. “You can train the immune system to recognize those proteins.” Vilar-Sanchez is an author of one of the studies, which was published Jan.16, 2026, in Nature Medicine. In the study, 45 people with Lynch syndrome underwent a baseline colonoscopy before receiving an experimental vaccine. The vaccine produced immune responses in all 37 evaluable participants, and 85% continued to have detectable responses one year later. Vilar-Sanchez said he expects a larger study to begin in 2027.

U.S. Slow to Use MRIs Before Prostate Biopsy

Health systems in Europe, Canada and Australia routinely use prostate MRIs before performing a prostate biopsy for men suspected of having prostate cancer. But in the U.S., only about a third of men had an MRI before undergoing a prostate biopsy in 2022, according to a report in STAT. A systematic prostate biopsy takes tissue samples from multiple areas of the prostate. An MRI can identify suspicious lesions and help doctors direct biopsy needles toward those areas. When an MRI shows no signs of suspicious lesions, doctors may decide a biopsy is unnecessary. Some research shows the use of MRI allowed between 30% to 50% of men to avoid biopsies, STAT reported. Some doctors note systematic biopsies provide value because they can find cancers that might not appear on an MRI. “If I’m a public health expert trying to say, ‘How do we find the only cancers we want and not get too many overdiagnoses?’, then the answer is MRI-targeted [biopsy] alone,” Tyler Seibert, a radiation oncologist at Moores Cancer Center in San Diego, told STAT. “If I’m an oncologist treating a patient, which is what I do more, I want the information from the systematic biopsy. Both of those strategies are very reasonable and appropriate and even data-driven. … It’s not so clean and easy that one is absolutely better than the other in my mind.”