Study Reaffirms Low Risk for csPCa with Biopsy Omission After Negative Prostate MRI

New research shows that negative findings with pre-biopsy magnetic resonance imaging (MRI) could prevent unnecessary prostate biopsies in a prevailing number of men with suspected prostate cancer (PCa).

In the 56-site prospective trial, recently published in JAMA Oncology, researchers reviewed data from 593 biopsy-naïve men (median age of 64) suspected of having clinically significant PCa (csPCa). All study participants had pre-biopsy 3T multiparametric MRI (mpMRI), according to the study.

The study authors noted that 48 percent (286 men) of the cohort had negative mpMRI findings and 261 of these men did not have an immediate prostate biopsy (PB). For 233 men who had a negative baseline MRI, three-year monitoring (including biannual follow-up) and no PB, the study authors noted that 4 percent were diagnosed with PCa.¹

“The main finding of this prospective, multisite trial demonstrated that pre-biopsy prostate MRI, as an integral component of the MRI pathway, is feasible in a community-based setting and oncologically safe,” wrote lead study author Charlie A. Hamm, M.D., Ph.D., who is affiliated with the Department of Radiology at Charite-Universitatsmedizin Berlin and the Berlin Institute of Health in Germany, and colleagues.

For biopsy-naïve men, the researchers emphasized the 96 percent negative predictive value (NPV) of pre-biopsy MRI in a cohort that had a 29 percent prevalence of csPCa.¹

“These findings provide prospective evidence for the negative predictive value of MRI, surpassing the 90.8% reported in a recent systematic literature review,” added Hamm and colleagues.²

The researchers also noted a 32 percent cumulative incidence of follow-up MRI exams at three years for patients who had positive baseline MRI results in contrast to 15 percent for those with a negative baseline MRI and active monitoring. However, the prevalence of csPCa at three years was only slightly higher for those who had positive baseline MRI exams in comparison to men with a negative MRI (7 percent vs. 4 percent).

“ … Clinical monitoring did not lead to a great increase of follow-up imaging and, therefore, higher costs,” pointed out Hamm and colleagues.

(Editor’s note: For related content, see “Study Shows MRI-Targeted Biopsies Reduce Overdiagnosis of Clinically Insignificant PCa by 57 Percent,” “Can MRI-Based AI Bolster Biopsy Decision-Making in PI-RADS 3 Cases?” and “Emerging AI Platform Shows Promise for Prostate Cancer Detection on mpMRI.”)

In regard to study limitations, the authors cautioned against broad extrapolation of the study results, noting that the reviewed MRIs were drawn from two high-volume academic facilities and assessed by two expert radiologists. The researchers also pointed out that no AI diagnostic software was utilized and that recent advances in risk stratification, such as prostate-specific antigen calculation, were not incorporated into the current study.

References

1. Hamm CA, Asbach P, Pohlmann A, et al. Oncological safety of MRI-informed biopsy decision-making in men with suspected prostate cancer. JAMA Oncol. 2024 Dec 12. doi: 10.1001/jamaoncol.2024.5497. Online ahead of print.

2. Sathianathen NJ, Omer A, Harriss E, et al. Negative predictive value of multiparametric magnetic resonance imaging in the detection of clinically significant prostate cancer in the prostate imaging reporting and data system era: a systematic review and meta-analysis. Eur Urol. 2020;78(3):402-414.