New prostate imaging outperforms biopsies for diagnosis, studies find

Prostate cancer diagnosis may be on the verge of a transformation: new research shows that a molecular imaging technique, PSMA PET/CT, significantly outperforms traditional systematic biopsy at finding clinically significant prostate cancer — and may let many men skip biopsy altogether.

Two studies, one direction

The phase III PRIMARY2 trial, presented at the European Association of Urology Congress (EAU26), enrolled 660 high-risk individuals. It found that adding PSMA PET/CT after an inconclusive or reassuring MRI could safely cut prostate biopsies by about 50 percent without missing clinically significant cancers.

The FUPERMAN study, published in the September issue of the Journal of Nuclear Medicine by a team in Bologna, Italy, compared biopsy strategies head to head. Sixty-three men with negative or equivocal multiparametric MRI scans but persistent clinical risk factors underwent 68Ga-PSMA-11 PET/CT followed by PET fusion-guided biopsy. PSMA PET/CT was positive in 25 of the 26 men ultimately diagnosed with clinically significant cancer. PET-guided targeted biopsy detected clinically significant cancer in 37% of the study population, versus 21% with systematic biopsy alone; combining both approaches raised the detection rate to 41% — nearly doubling it.

Imaging combos could eliminate up to 57% of biopsies

A German study combining 18F-flotufolastat PSMA PET with multiparametric MRI reported an area under the curve (AUC) of 87.1% for detecting clinically significant cancer, compared with 75.2% for MRI alone and 80.7% for PET alone. The researchers estimated the combined strategy could have eliminated the need for biopsy in 57% of the patients studied.

Artificial intelligence is joining the effort too. An international, multicenter retrospective study of 787 men in Germany, the Netherlands and the United States found that combining radiologists' MRI assessments with AI risk classification could have avoided 149 biopsies (18.9%) while maintaining 98.4% sensitivity for clinically significant disease.

Biopsy is still the gold standard — but it hurts

Researchers repeatedly stress that prostate biopsy remains the diagnostic gold standard. Yet it is invasive, causes pain and anxiety, and carries risks of bleeding, infection and urinary complications. Between 20% and 30% of clinically significant prostate cancers may be missed when MRI findings are negative or inconclusive — the exact gap PSMA imaging aims to fill.

"If confirmed in larger studies, this approach could make the diagnostic pathway more accurate and personalized," said Andrea Farolfi, M.D., a nuclear medicine physician at the IRCCS Azienda Ospedaliero-Universitaria di Bologna and the FUPERMAN study's lead author.

Caveats apply: these are single-center or retrospective studies. Researchers are calling for larger prospective trials to confirm whether imaging-guided strategies can truly deliver biopsy-free diagnosis for selected patients.