Consumer update: Prostate cancer symptoms, tests and treatments

Sept. 20, 2023

On Sept. 19, the FDA informed the public in the Prostate Cancer Symptoms, Tests and Treatments Consumer Update that the agency regulates certain tests and treatments for prostate cancer to ensure they are safe and effective. Prostate cancer is the most common cancer among men in the U.S. and the second most common cause of cancer-related deaths. And African American men are more likely to get prostate cancer and twice as likely to die from the disease than men of other races.

A blood test that measures prostate-specific antigen (PSA) can be used to help with the detection of prostate cancer, although it is not recommended for screening in all cases. PSA is a protein produced by cells of the prostate gland.

Other factors that may help to put the PSA into context to better understand the risk of prostate cancer include age, race, family history, prostate size, urinary tract infection or irritation, medications and rate of PSA rise.

Because of the widespread use of PSA testing in the U.S., prostate cancer is often detected early. In some cases, the prostate cancer found can be very slow-growing, and this can lead to overtreatment.

“In most of these cases, the prostate cancer may not require treatment, and the use of PSA testing to screen for prostate cancer is controversial,” says Daniel Suzman, M.D., a medical oncologist at the FDA.

The U.S. Preventive Services Task Force – an independent, volunteer panel of national experts in prevention and evidence-based medicine – recommends against PSA-based screening for prostate cancer in men age 70 and older because of:

  • The lack of data that screening increases survival rates.
  • The risk of overtreatment, leading to side effects in men who otherwise would never have experienced any symptoms.

For men ages 55 to 69, the task force recommends an individualized discussion of the risk and benefits of screening.

Imaging of the prostate, such as magnetic resonance imaging (MRI), may help with detecting prostate cancer. If the risk of prostate cancer is high, a health care professional performs a biopsy to remove a sample of prostate tissue for examination to determine if cancer is present and, if so, how aggressive the cancer appears.

The appearance of aggressiveness under the microscope is described by a Gleason score, which is assigned by the pathologist (a doctor who examines bodies and body tissues). Depending on the overall risk for prostate cancer that has spread outside the prostate, additional imaging may be needed to recommend a treatment plan.

FDA has more information.