Risks of grade reclassification among patients with Gleason grade group 1 prostate cancer and PI-RADS 5 findings on prostate MRI

Background and objective: As most Prostate Imaging Reporting and Data System (PI-RADS) 5 lesions on MRI harbor Gleason grade (GG) group ≥2 disease on biopsy, optimal management of patients with imaging-biopsy discordance remains unclear. To estimate grade misclassification, we evaluated the incidence of Gleason upgrading among patients with GG1 disease in the setting of a PI-RADS 5 lesion.

Methods: We conducted a single-institution retrospective analysis to identify patients with GG1 prostate cancer on fusion biopsy with MRI demonstrating ≥1 PI-RADS 5 lesion. Primary study outcome was identification of ≥GG2 disease on subsequent active surveillance (AS) biopsy or radical prostatectomy (RP). We used multivariable models to examine factors associated with reclassification.

Results: We identified 110 patients with GG1 disease on initial biopsy and ≥1 PI-RADS 5 lesion. There were 104 patients (94.6%) initially managed with AS and 6 (5.5%) received treatment. Sixty-one patients (58.7%) on AS underwent additional biopsies. Of these, 43 (70.5%) patients had tumor upgrading, with 32 (74.4%) upgraded on first surveillance biopsy. Forty-four (40%) patients ultimately received treatment, including prostatectomy in 15 (13.6%) and radiation in 25 (22.7%). Two patients (1.8%) developed metastases. In multivariable models, genomic classifier score was associated with upgrading. Limitations include a lack of multi-institutional data and long-term outcomes data.

Conclusions: Most patients diagnosed with GG1 prostate cancer on MRI-Ultrasound fusion biopsy in the setting of a PI-RADS 5 lesion were found to have ≥GG2 disease on subsequent tissue sampling, suggesting substantial initial misclassification and reinforcing the need for confirmatory testing.