A recent scientific article confirms that a new rapid urine test, called ZenPSA-pro, can help avoid prostate biopsy in those who do not have prostate cancer.
The prostate cancer is one of the most common malignancies in the male population. Despite this, its diagnosis remains a complex, often lengthy, and, above all, fraught with uncertainty.
Many men undergo invasive prostate biopsies without subsequently receiving a diagnosis of clinically significant cancer.
While not having cancer is certainly good news, having to undergo visits and tests brings anxiety, stress, possible complications, and a significant impact on the healthcare system, without any real benefit for the patient.
A new study, conducted at theSan Luigi Gonzaga Hospital in Orbassano by the Urology team coordinated by Professor Francesco Porpiglia, active both at San Luigi and at IRCCS in Candiolo, the results of which were published in the journal Prostate cancer and prostatic diseases, proposes a possible breakthrough: a rapid urinary test to measure PSA and zinc, two molecules closely linked to the physiology of the prostate.
The results are promising and suggest that this simple test could reduce unnecessary biopsies by up to 50% in healthy men or men with clinically insignificant disease.
The limit of the current diagnostic pathway
The Serum PSA has been the cornerstone of prostate cancer screening and diagnosis for decades. However, its low specificity is well known: elevated levels may be associated with benign conditions such as prostatic hyperplasia or prostatitis.
The introduction of multiparametric magnetic resonance imaging (mpMRI) has reduced false positive PSA results, but has not completely solved the problem.
Even after MRI, there are many borderline cases, such as patients with PIRADS 3 and PSA in the so-called gray zone..
The result is that a significant percentage of men undergo prostate biopsy without identifying a clinically significant tumor, that is, a malignancy requiring immediate treatment.
Why urine, PSA and zinc?
In recent years, there has been a rush to develop new biomarkers, based on blood, urine, or tissue. Many of these tests rely on complex molecular or genetic analyses.
However, prostate cancer is often multifocal and extremely genetically heterogeneous: a single molecular signature can hardly represent the diverse diseases that develop in men around the world.
The approach developed by NIB biotec and validated by the Orbassano group is conceptually different and biologically intuitive.
PSA and zinc (uPSA and uZinc) are normal byproducts of a healthy, functioning prostate. Neoplastic transformation leads to a progressive loss of these physiological functions.
Measuring them in urine therefore means observing not so much "what the tumor produces," but what the prostate stops doing when it becomes diseased. And this happens progressively as the tumor develops within the organ.
This concept had already been demonstrated in previous studies by the same research group. In particular, Amparore et al. (2024, Minerva Medica) had shown how urinary PSA and zinc levels were significantly lower in patients with prostate cancer and inversely correlated with the aggressiveness of the disease.
The new ZenPSA-pro test: what does it add?
The recently published study aimed to clinically validate a rapid urinalysis test that can be used directly in the clinic, without the need for a centralized laboratory.
The main findings can be summarized in three key points:
- Analytical reliability
The rapid test shows a strong correlation with standard laboratory methods for measuring urinary PSA and zinc, confirming its reliability. - Correlation with aggressiveness and stage of the disease
Urinary PSA and zinc levels are inversely correlated with ISUP grading, clinical stage and risk of progression. - Reduction of unnecessary biopsies
Fifty-one percent of men who were not diagnosed with prostate cancer tested negative on urine tests, suggesting that more than half of the biopsies performed on healthy men could have been avoided.
An added value in doubtful cases
The setting in which the test appears to offer the greatest benefit is the most problematic: patients with PIRADS 3 and borderline PSA. Not surprisingly, the most recent EAU 2025 Guidelines are revising the indication for biopsy in these cases, suggesting a more selective approach, but the criteria are still not unequivocal and shared.
In this scenario, a simple and rapid urine test could represent a triagetool, capable of distinguishing those who truly require further investigations from those who can be followed up with careful follow-up.
A consolidated line of research in Turin
This work is part of a broader line of research started at the Città della Salute e della Scienza di Torino.
Previous studies, such as that of Occhipinti et al. (2021, Cancers) and Maddalone et al. (2023, Cancers), separately observed the ability of PSA and urinary zinc to represent interesting biomarkers, to design integrated strategies to improve the selection of patients who are candidates for biopsy.
Furthermore, the first prototype of the urinary test for the combined measurement of PSA and Zinc was developed in collaboration with the analytical chemistry group of theUniversity of Torino, laying the technological and methodological foundations for subsequent clinical studies.
Impact on patients, doctors and the healthcare system
Perhaps the most revolutionary aspect of this test is not only its accuracy, but also its method of use. Being able to perform it directly in the clinic:
- reduces patient anxiety, avoiding long and uncertain diagnostic processes;
- facilitates access to a diagnostic pathway by decentralizing the tests;
- improves clinical workflow, enabling better prioritization;
- reduces waiting times for invasive and expensive tests;
- reduces healthcare costs by avoiding unnecessary procedures;
- strengthens the doctor-patient relationship, thanks to a shared decision based on additional information.
In an era of increasing pressure on healthcare systems, a simple, affordable, and decentralized test represents enormous value, even in resource-limited settings.
This new urine test for PSA and zinc does not promise to “replace” existing diagnostic tools, but to make them smarter and less invasive.
Reducing unnecessary biopsies without compromising the diagnosis of clinically significant tumors means improving the quality of care, protecting patients, and optimizing resources.
The next step will be to finalize the industrial product and obtain certification.
If the results are confirmed on a large scale, we could be faced with a small but significant change in the diagnostic process for prostate cancer.
READ THE ARTICLE: https://www.nature.com/articles/s41391-025-01030-2#Fun
DOWNLOAD PDF: https://rdcu.be/eTSnG