Biparametric MRI is noninferior to multiparametric MRI for prostate cancer diagnosis

Abbreviated biparametric MRI was found to be noninferior to multiparametric MRI in the detection of clinically significant prostate cancer, according to data from the PRIME trial (NCT04571840), published in JAMA.¹

Biparametric MRI omits the gadolinium contrast sequence and offers a shorter a cheaper alternative for prostate cancer diagnosis. According to the authors, findings from the PRIME trial suggest that biparametric MRI could become the new standard of care for prostate cancer diagnosis.

“Currently around 4 million MRI scans are needed each year globally to diagnose prostate cancer. This demand is set to rise rapidly with a predicted surge in prostate cancer cases over the next 20 years,” explained principal investigator Veeru Kasivisvanathan, PhD, associate professor at the University College London (UCL), in a news release from UCL.² “Time, cost and staff availability are all limiting factors in how many scans can be offered, which makes the results of the PRIME trial particularly important. If we can do the scan in up to half the time, with fewer staff and at lower cost, that will make a huge difference in allowing every man who needs a scan to be able to get one in a timely fashion.”

In total, the prospective trial enrolled 490 biopsy-naïve men through 22 clinical trial sites across 12 countries. All men had clinical suspicion of prostate cancer based on a rising prostate-specific antigen (PSA) level and/or abnormal findings on digital rectal examination (DRE). The median age of patients was 65 years (IQR, 59 to 70), and the median PSA level was 5.6 ng/mL (IQR, 4.4 to 8.0).

Biparametric and multiparametric MRI scans were assessed for each patient. Targeted biopsy with or without systematic biopsy was performed to confirm the accuracy of the diagnosis. The primary end point was the proportion of men with clinically significant prostate cancer (Gleason grade group 2 or higher), and the secondary end point was the proportion of men with clinically insignificant prostate cancer. The non-inferiority margin was 5%.

Data showed that biparametric MRI was noninferior to multiparametric MRI. Overall, clinically significant prostate cancer was detected in 29.2% of patients with biparametric MRI vs 29.6% of patients with multiparametric MRI (difference, −0.4; 95% CI, −1.2 to 0.4 percentage points; P = .50). Further, biparametric MRI detected clinically insignificant prostate cancer in 9.2% of men, vs 9.6% of patients with multiparametric MRI (difference, −0.4; 95% CI, −1.2 to 0.4 percentage points).

According to the authors, 99% of scans were of adequate diagnostic quality per central quality control analysis.

The authors noted, “In men with suspected prostate cancer, provided image quality is adequate, an abbreviated biparametric MRI scan, with or without targeted biopsy, could become the new standard of care for prostate cancer diagnosis. With approximately 4 million prostate MRIs performed globally annually, adopting biparametric MRI could substantially increase scanner throughput and reduce costs worldwide.”

Building on the findings from PRIME, the TRANSFORM trial is set to begin later this year. The study, which represents the largest prostate cancer screening trial for 20 years, will seek to determine the safest, most accurate, and most cost-effective way to screen men for prostate cancer.³ The results from this trial are expected to support the introduction of a national screening program in the UK.

“The results from the PRIME trial, showing that a faster, cheaper, type of prostate MRI is just as good as the current standard MRI at detecting prostate cancer, [is] a hugely important step in the right direction for making MRIs more efficient,” said Matthew Hobbs, PhD, director of research at Prostate Cancer UK, in the news release.² “Another trial is already happening in the UK, and the results of the 2 trials together should provide the complete evidence package we need to change practice across the country. We encourage NICE to prepare to review their guidelines as soon as that evidence base is complete, so that we can make MRI quicker, cheaper and less onerous for men.”

REFERENCES

1. Ng ABCD, Asif A, Agarwal R, et al. Biparametric vs multiparametric MRI for prostate cancer diagnosis: The PRIME diagnostic clinical trial. JAMA. 2025 Sep 10:e2513722. doi:10.1001/jama.2025.13722

2. Millions of men could benefit from faster scan to diagnose prostate cancer. News release. University College London. September 10, 2025. Accessed September 15, 2025. https://www.eurekalert.org/news-releases/1097495

3. TRANSFORM trial. Prostate Cancer UK. Accessed September 15, 2025. https://prostatecanceruk.org/research/transform-trial