The test could be a step closer to personalized risk-based prostate cancer diagnostic programs, study authors say.
A leading prostate cancer expert told Urology Times he is “very excited about the prospects of this work.”
The study, published online in The Lancet Oncology (Nov. 9, 2015), found the STHLM3 test, a blood test that analyzes a combination of six protein markers, more than 200 genetic markers, and clinical data, identifies aggressive cancer earlier and reduces false positives and unnecessary biopsies compared to PSA.
“PSA can’t distinguish between aggressive and benign cancer. On top of this, PSA misses many aggressive cancers. We therefore decided to develop a more precise test that could potentially replace PSA,” said principal investigator Henrik Grönberg, MD, PhD, of Karolinska Institutet, Solna, Sweden in a press release about the study.
Conducted between 2012 and 2014, the study involves 58,818 men from Stockholm, Sweden, ages 50 to 69 years. The STHLM3 test and PSA were performed on all participants and compared.
The authors reported the STHLM3 test outperformed PSA in men with a Gleason score of 7 or more. It reduced the number of biopsies by 30% without compromising patient safety. The STHLM3 test also found aggressive cancers in men with low PSA values (1 ng/mL-3 ng/mL), according to the release.
At the sensitivity level of the PSA test using a cutoff of ≥3 ng/mL to diagnose high-risk prostate cancer, use of the STHLM3 model could reduce the number of biopsies by 32% and could avoid 44% of benign biopsies, according to the study.
The new test could be a step closer to personalized risk-based prostate cancer diagnostic programs, the authors wrote.
Urology Times Editorial Consultant J. Brantley Thrasher, MD, of the University of Kansas Medical Center, Kansas City, discussed the study with UT.
“I am very excited about the prospects of this work. As the authors point out, many of the poorly differentiated prostate cancers have low PSAs and, if this new test can diagnose those cancers, that is a big plus for the practicing urologist,” Dr. Thrasher told Urology Times.
“Obviously, the study findings need to be validated in other groups and other ethnic populations,” added Dr. Thrasher, who was not involved with the study.
The test was developed by researchers at Karolinska Institutet in collaboration with Thermo Fisher Scientific, which provided the protein and genetic marker assays used in the clinical study.
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