New urine-based test to detect Prostate Cancer could replace painful biopsies

Prostate cancer is the most common cancer and the second leading cause of cancer death among men in the United States. To confirm the diagnosis, biopsies are required. A team of researchers has now developed a urine-based test that could revolutionize prostate cancer detection and potentially eliminate the need for painful invasive biopsies.

A new study led by researchers at the Johns Hopkins Kimmel Cancer Center, Johns Hopkins All Children’s Hospital, and four other institutions has created a new method to test for prostate cancer using biomarkers present in urine. The findings are published in eBioMedicine.

What is prostate cancer?

Prostate cancer is a form of cancer that begins in the prostate gland. The prostate is a gland found only in males. It contributes to some of the fluid that is part of semen. When the cells in the prostate gland start to grow out of control, it leads to cancer.

According to the CDC, out of every 100 American men, about 13 will develop prostate cancer during their lifetime, and about 2 to 3 men will die from it. In some the cancer grows slowly; however, in other cases, it can spread quickly and become harder to treat. Early diagnosis is crucial for better treatment options, outcomes, and the chances of long-term survival. This cancer is diagnosed using screening tests, physical exams, scans, and a biopsy to confirm it.

New urine-based test could replace painful biopsies

The new test developed by the researchers could significantly reduce the need for invasive, often painful biopsies. To develop the new test, the researchers analyzed urine samples from prostate cancer patients before and after prostate-removal surgery. They also collected samples from healthy individuals. The researchers identified a panel of three biomarkers — TTC3, H4C5, and EPCAM, that robustly detected the presence of prostate cancer. These biomarkers were detectable in patients prior to surgery but were nearly absent post-surgery, confirming that they originated in prostate tissue.

They tested the three-biomarker panel in a development and validation group. The test had an area under the curve (AUC) of 0.92 (1.0 is a perfect performance), and accurately identified prostate cancer 91% of the time. The new test also accurately ruled out people without prostate cancer 84% of the time in the validation study.

Beyond the PSA test

Prostate cancer is typically detected with a PSA blood test to measure PSA (prostate-specific antigen), a protein produced by cancerous and noncancerous tissue in the prostate. A PSA level above 4.0 nanograms per milliliter is considered abnormal. In such cases, a prostate biopsy is recommended, where multiple samples of tissue are collected through small needles.

However, the PSA test is not very specific, which means, prostate biopsies are often required to confirm the diagnosis of cancer, according to senior study author Ranjan Perera, Ph.D., director of the Center for RNA Biology at Johns Hopkins All Children’s Hospital in St. Petersburg, Florida, and a professor of oncology and neurosurgery at the Johns Hopkins University School of Medicine.

What’s more distressing is that, in many cases, the biopsies come back negative and can result in unintended complications. Also, PSA tests can lead to unnecessary treatment for very low-grade prostate cancers that are very unlikely to grow and spread over a short period of time.

“This new biomarker panel offers a promising, sensitive, and specific, noninvasive diagnostic test for prostate cancer. It has the potential to accurately detect prostate cancer, reduce unnecessary biopsies, improve diagnostic accuracy in PSA-negative patients, and serve as the foundation for both laboratory-developed and in vitro diagnostic assays,” says Perera, in a statement.

The researchers were able to detect prostate cancer even when PSA was in the normal range and could distinguish prostate cancer from conditions like prostatitis (inflammation of the prostate) and an enlarged prostate, a condition known as benign prostatic hyperplasia (BPH).



“There is a real need for non-PSA-based biomarkers for prostate cancer, and urine is quite easy to collect in the clinic. Most urologists feel that an accurate urinary biomarker would be a valuable addition to our current diagnostic armamentarium,” study co-author Christian Pavlovich, M.D., the Bernard L. Schwartz Distinguished Professor of Urologic Oncology at Johns Hopkins and program director for the Prostate Cancer Active Surveillance Program, said.

How the new urine-based test could help?

The novel test developed by the researchers could possibly replace the painful invasive tests. “This test has the potential to help physicians improve the diagnostic accuracy of prostate cancer, reducing unnecessary interventions while allowing early treatment for those who need it. On behalf of physicians and patients globally, I advocate for further study and progress for these biomarkers,” study co-author Vipul Patel, M.D., director of urologic oncology at AdventHealth Cancer Institute in Celebration, Florida, adds. Patel is also the medical director of global robotics for AdventHealth’s Global Robotics Institute, and the founder of the International Prostate Cancer Foundation.