New Study: PSMA-PET Imaging Helps Nearly Half of Men Avoid Unnecessary Prostate Biopsy

Published: April 2026 • Written by David Robbins, MD, Board-Certified Urologist, North Miami, FL

For decades, one of the biggest challenges in prostate cancer care has been overdiagnosis—finding cancers that would never cause harm, leading to unnecessary biopsies, anxiety, and sometimes unnecessary treatment. A landmark study presented at the 2026 European Association of Urology Congress in London offers a significant step forward.

The PRIMARY2 trial, a multi-center phase 3 randomized study, found that adding PSMA-PET/CT imaging to the diagnostic pathway for men with non-suspicious or equivocal MRI findings allowed 49 percent of patients to avoid biopsy entirely—without missing clinically significant cancer.

What Is PSMA-PET?

PSMA-PET/CT (prostate-specific membrane antigen positron emission tomography) is an advanced imaging technique that uses a radioactive tracer to identify prostate cancer cells with high precision. PSMA is a protein that is overexpressed on the surface of prostate cancer cells, making them visible on PET imaging. This technology has already been widely adopted for staging advanced prostate cancer, but the PRIMARY2 trial demonstrates its potential value earlier in the diagnostic pathway—specifically for men who have had an MRI that shows no clear suspicious lesion.

What Did the PRIMARY2 Trial Find?

The trial enrolled men with elevated PSA who underwent prostate MRI and were found to have equivocal or non-suspicious findings (PI-RADS 2 or 3). Traditionally, many of these men would still undergo systematic biopsy. In the study:

• 49 percent of men in the PSMA-PET arm avoided biopsy
• Detection of clinically significant cancer was non-inferior to standard systematic biopsy (12% vs. 16%)
• Diagnosis of clinically insignificant cancer was dramatically reduced (14% vs. 32%)

In other words, PSMA-PET helped identify men who truly needed a biopsy while sparing nearly half the group from an invasive procedure they did not need—and cutting the diagnosis of harmless cancers roughly in half.

Why This Matters for Patients

Prostate biopsy is safe and routine, but it is still an invasive procedure with potential side effects including discomfort, bleeding, and a small risk of infection. More importantly, finding a clinically insignificant cancer can trigger a cascade of anxiety, additional testing, active surveillance, and in some cases, treatment that may not have been necessary. Any technology that can reliably distinguish men who need a biopsy from those who do not is a meaningful advance.

What Should You Do About PSA Screening?

The PRIMARY2 results do not change the importance of PSA screening—they improve what happens after a PSA result raises concern. If you are a man over 50 (or over 40 with risk factors such as family history or African American race), regular PSA screening remains one of the most important things you can do for early prostate cancer detection.

At Urological Consultants of Florida, Dr. Robbins offers comprehensive prostate health services including PSA screening, MRI-ultrasound fusion targeted prostate biopsy, and personalized cancer risk assessment.

Call (305) 575-2771 to schedule a prostate health evaluation.