Results from the phase 3 PRECISE trial showed that MRI with targeted biopsies matched or exceeded the accuracy of the current standard for detecting clinically significant prostate cancer.
Results from the phase 3 Prostate Evaluation for Clinically Important Disease: MRI vs Standard Evaluation Procedures (PRECISE) trial showed that MRI with targeted biopsies (MRI-TBx) matched or exceeded the accuracy of the current standard for detecting clinically significant prostate cancer.1
The current standard, a systematic 12-core transrectal ultrasound-guided (TRUS) biopsy (TRUS-Bx), can potentially lead to overdiagnosis in low-risk prostate cancer and underdiagnosis in some cases of higher risk prostate cancer.2 Repeat biopsies, overtreatment of insignificant disease, and delayed or misdiagnosis of clinically significant disease can result.
Authors of the new study, which was published in JAMA Oncology, aimed to find out whether MRI-TBx—only targeting lesions with a Prostate Imaging Reporting and Data System (PI-RADS) version 2.0 score of 3 or greater—would be noninferior to the 12-core TRUS-Bx in detecting International Society of Urological Pathology grade group 2 (GG2) or greater prostate cancer.
The study included biopsy-naïve patients suspected of having prostate cancer who were told to undergo a biopsy. Criteria included:
- Clinical suspicion, defined as a 5% or greater chance of GG2 or higher prostate cancer using the Prostate Cancer Prevention Trial Risk Calculator, version 2
- Serum prostate-specific antigen levels of 20 ng/mL or less
- No contraindication to MRI
In an intention-to-treat population of 453 patients, 226 (49.9%) were randomized to undergo TRUS biopsy, and 227 (51.1%) underwent MRI. Of those patients, 421 (93%) were evaluable. PI-RADS 3 or higher lesions were found in 128 of the patients who underwent MRI. Of those men, 12.1% had maximum PI-RADS scores of 3, 38.1% had maximum scores of 4, and 12% had scores of 5.
GG2 and greater cancers were identified in 30% of patients in the TRUS-Bx cohort, compared with 35% in the MRI-TBx cohort, which the authors note indicates the MRI-TBx arm at least matches the performance of the standard TRUS-Bx. Adverse events were also less common in the MRI-TBx cohort. Negative MRI results led to 83 (37%) of the men in the MRI cohort avoiding biopsies altogether. Overdiagnosis of clinically insignificant prostate cancer was also reduced in the MRI-TBx group, from 22% to 10%.
"My colleagues and I are thrilled about these results that show, without a doubt, that imaging and targeted biopsies are the future of prostate cancer diagnosis. We can catch more of the cancers we should be treating, avoid unnecessary treatment at the same time and improve the quality of life for our patients," lead study author Laurence Klotz, MD, chair of prostate cancer research at Sunnybrook Health Sciences Centre, said in a statement.3 "We thank the study participants and our funders for their support and look forward to continuing our efforts to have this technology used more widely."
References
1. Klotz L, Chin J, Black PC, et al. Comparison of multiparametric magnetic resonance imaging–targeted biopsy with systematic transrectal ultrasonography biopsy for biopsy-naive men at risk for prostate cancer. JAMA Oncol. Published online February 4, 2021. doi:10.1001/jamaoncol.2020.7589
2. Churukanti G, Siddiqi MM.MRI–TRUS fusion biopsy versus 12-core systematic biopsy. Nat Rev Urol. Published online June 16, 2015. doi:10.1038/nrurol.2015.143
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