Prostate cancer is second only to lung cancer as the leading cause of cancer death in American men. According to the American Cancer Society, roughly 1 in 44 men will die of the disease.
The main tool used to diagnose prostate cancer – a transrectal biopsy – is invasive and infection-prone. The procedure involves collecting tissue with a needle through the rectum.
Studies have found that 5-7% of patients develop infections after a prostate biopsy, and 1-3% require hospitalization for infection-related complications.
Given the prevalence of prostate cancer and the risks associated with its detection, a group of researchers believed it was time for a new and better method. They recently published the results of a multi-institutional clinical trial focused on just that.
The new technique, known as transperineal prostate biopsy, uses a needle to collect prostate tissue from the skin of the perineum, the area between the rectum and the scrotum. Local anesthesia is used in the procedure to numb the area.
The clinical trial, known as the PReclude infection EVEnts with No prophylaxis Transperineal (PREVENT) trial, was led by Weill Cornell Medicine and NewYork-Presbyterian investigators and took place at multiple sites, including NewYork-Presbyterian/Weill Cornell Medical Center, NewYork-Presbyterian Queens and NewYork-Presbyterian Brooklyn Methodist Hospital.
The study, which was recently published in JAMA Oncology, found no infections among 382 men randomized to undergo the transperineal procedure compared with six infections affecting 1.6% of the 370 men randomized to undergo the traditional transrectal biopsy procedure.
The researchers noted that the lower infection rate is “particularly remarkable because the men in the transrectal biopsy group received a targeted course of antibiotics designed to help reduce their infection risk, and the men in the transperineal group received no antibiotics.”
“Transperineal biopsy should be the new standard of care for prostate biopsy,” said Dr. Jim Hu in a news release. Dr. Hu is the Ronald P. Lynch Professor of Urologic Oncology at Weill Cornell Medicine and the director of the LeFrak Center for Robotic Surgery at NewYork-Presbyterian/Weill Cornell Medical Center.
“It was as effective as the traditional transrectal biopsy approach at detecting cancer, but without the risk of infection or the need for antibiotics,” said Hu.
“Transperineal prostate biopsy makes a common diagnostic procedure safer for men. It also eliminates the use of antibiotics, helping to reduce the emergence of antibiotic-resistant infections, a growing public health concern,” he added.
While the new procedure shows significant promise as a less invasive and lower risk test, Dr. Hu and the other researchers acknowledge some initial barriers to its adoption. For example, few physicians in the US are currently trained in the procedure. In addition, insurers pay the same amount for either the transrectal biopsy or the transperineal biopsy, but the new method is more costly and time-intensive, which can dissuade some physicians.
That said, Dr. Hu remains optimistic that the tide will eventually turn and transperineal biopsy will someday become the new standard of care. He cites the transition to transperineal prostate biopsies in Norway, spurred by the death of a man who received a routine transrectal prostate biopsy. The country has virtually eliminated biopsy-related infections and deaths following the switch.
“There is a strong case to make the switch,” said Dr. Hu. “It will take time. But as more patients request the new procedure, we think it will become more widely available.”