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 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
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.



