Study examines biopsy after negative or inconclusive MRI
PSMA PET/CT-targeted biopsy detected more clinically significant prostate cancer than systematic biopsy alone in men with negative or inconclusive MRI findings but persistent clinical risk factors, according to research published in The Journal of Nuclear Medicine. Combining the two biopsy approaches further increased the detection rate.
The prospective, single-center study included 63 men with negative or inconclusive MRI scans. All underwent 68Ga-PSMA-11 PET/CT followed by PET fusion-guided prostate biopsy.
Researchers assessed the diagnostic performance of PSMA PET/CT-guided targeted biopsy compared with systematic biopsy. They also examined whether semiquantitative and dynamic total-body PET parameters could help predict clinically significant prostate cancer.
Higher detection with targeted biopsy
PSMA PET/CT was positive in 25 of the 26 men who were ultimately diagnosed with clinically significant prostate cancer.
PSMA PET/CT-targeted biopsy detected clinically significant cancer in 37% of the study population, compared with 21% with systematic biopsy alone. When the two approaches were combined, the detection rate increased to 41%.
SUVmax was independently associated with clinically significant disease. In 11 patients, dynamic total-body PET showed distinct kinetic patterns in aggressive lesions, particularly in unclear cases.
Potential role in patients with nondiagnostic MRI
Negative or inconclusive MRI findings do not necessarily exclude clinically significant prostate cancer. Andrea Farolfi, M.D., a nuclear medicine physician at the Nuclear Medicine Unit, IRCCS Azienda Ospedaliero-Universitaria di Bologna, described the potential implications for patients who remain at risk:
"A negative or unclear MRI does not completely rule out clinically significant prostate cancer. As a result, some men may undergo repeated or extensive biopsies, while relevant tumors may still be missed."
The study also examined whether PSMA PET could help refine risk assessment and guide biopsy sampling. Farolfi said: "Determining whether PSMA PET can refine risk stratification and guide targeted sampling for these men could have a direct impact on clinical decision-making."
The study indicates that PSMA PET/CT-targeted biopsy could provide an additional approach for identifying clinically significant prostate cancer in appropriately selected men with negative or inconclusive MRI findings. The authors said larger studies are needed to confirm the findings.
"Our findings suggest that PSMA PET/CT could provide an additional tool for identifying men who remain at risk despite nondiagnostic MRI findings and for directing the biopsy toward the most suspicious area. If confirmed in larger studies, this approach could make the diagnostic pathway more accurate and personalized." said Farolfi.









