Prostate cancer DNA test not ready for clinical use, warn urologists

A DNA test touted as a potential game-changer in prostate cancer screening may not be ready for prime time, despite promising clinical trial results, the Urological Society of Australia and New Zealand (USANZ) has warned.

Researchers behind the BARCODE 1 study used DNA extracted from saliva to calculate a polygenic risk score (PRS) of developing prostate cancer. In high-risk men, the PRODICT saliva test detected prostate cancer at a significantly higher rate than the traditional PSA blood test.

Following MRI scans and prostate biopsies, 40% of men with a high PRS were diagnosed with prostate cancer. By comparison, the PSA test identifies cancer in only 25% of men with elevated PSA levels. In addition, 66.8% of high-risk men had prostate cancer confirmed by biopsy that was missed on MRI, suggesting the saliva test could offer advantages in detecting cancers that evade current imaging tools.

Yet, USANZ Genitourinary (GU) Oncology Special Advisory Group Leader, Associate Professor Weranja Ranasinghe, is not convinced.

“It is very early days with further evidence needed on the saliva test before it can be compared with current screening methods of a PSA blood test and MRI for prostate cancer which focus on detecting aggressive disease,” he said.

“In its current form the saliva test has a number of dangers associated with it. The study shows the saliva test picks up dormant prostate cancers in men who will never have the disease affecting them in their lifetime and exposing a large number of patients to unnecessary biopsies. It is also worth noting the potential implications of giving your DNA to commercial companies,” said Associate Professor Ranasinghe added.

At a time when 23andMe has filed for bankruptcy and concerns about data privacy loom large, experts are wary of encouraging mass submission of genetic material without robust governance.

The BARCODE1 study remains ongoing, with full completion expected in December 2028. The researchers are also conducting the TRANSFORM trial to compare the saliva test with other screening options to determine the most accurate and cost-effective method for early detection.

Meanwhile, Australia is set to become the first country in the world to introduce national clinical guidelines for the early detection of prostate cancer, with the release of the 2025 draft guidelines for public comment.

Among the most significant is a world-first recommendation to offer a baseline PSA test to interested men from the age of 40. General practitioners (GPs) will be strongly encouraged to initiate conversations about PSA testing and offer two-yearly tests to men aged 50–69. The guidelines also overturn previous recommendations against testing men over 70, now advocating testing based on clinical judgment.

“There is no direct evidence the saliva test improves survival or quality of life so more research is needed which will take years. Our focus needs to build awareness and using the current methods to their full extent to detect prostate cancer early and has been proven to save lives,” said Associate Professor Ranasinghe.

Ten men die in Australia every day from prostate cancer that is now the most commonly diagnosed cancer in Australia with 26,000 men diagnosed each year. The need for more accurate screening is clear – but in the words of the local experts, we are not there yet.

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