PRECISION medicine.
Top Line: MRI better predicts which men have “clinically significant” prostate cancer (remember: Gleason score 3+4 or more) than the standard clinical info alone. Does it also better target clinically significant biopsies than the standard 12-core approach?
The Study: This one is all about using MRI to enhance your biopsy technique. The PRECISION trial is the first prospective randomized trial comparing MRI-informed and guided biopsies versus the go-to transrectal ultrasound (TRUS)-guided 12-cores. 500 patients without previous biopsy with either an elevated PSA (but not more than 20) and/or a suspicious digital rectal exam were randomized to a TRUS-guided 12-core biopsy (n=248) or to a diagnostic prostate MRI (n=252). Among those randomized to MRI, only those with suspicious findings (defined as PI-RADS 3-5) went on to MRI-guided biopsy (n=181...only 72%). The study was designed to establish non-inferiority of the MRI detection rate in an intention-to-treat fashion. Because, hey, a 28% rate of biopsy-sparing with MRI is inherently superior. The detection rates of clinically significant cancer were 95/252 (38%) with MRI and 64/248 (26%) without. This absolute difference of 12% (95% CI 4-20%) was not only non-inferior, it was statistically superior as pre-specified (i.e., 95% CI did not cross 0). Importantly, generalizability is fairly well-supported given patients were treated at 25 centers across 11 countries.
Bottom Line: Diagnostic prostate MRI followed by MRI-guided biopsy, only if warranted, detected significantly more clinically significant prostate cancers while avoiding almost half (71/157) of unnecessary biopsies. Wow. | Kasivisvanathan, N Engl J Med 2018
The Study: This one is all about using MRI to enhance your biopsy technique. The PRECISION trial is the first prospective randomized trial comparing MRI-informed and guided biopsies versus the go-to transrectal ultrasound (TRUS)-guided 12-cores. 500 patients without previous biopsy with either an elevated PSA (but not more than 20) and/or a suspicious digital rectal exam were randomized to a TRUS-guided 12-core biopsy (n=248) or to a diagnostic prostate MRI (n=252). Among those randomized to MRI, only those with suspicious findings (defined as PI-RADS 3-5) went on to MRI-guided biopsy (n=181...only 72%). The study was designed to establish non-inferiority of the MRI detection rate in an intention-to-treat fashion. Because, hey, a 28% rate of biopsy-sparing with MRI is inherently superior. The detection rates of clinically significant cancer were 95/252 (38%) with MRI and 64/248 (26%) without. This absolute difference of 12% (95% CI 4-20%) was not only non-inferior, it was statistically superior as pre-specified (i.e., 95% CI did not cross 0). Importantly, generalizability is fairly well-supported given patients were treated at 25 centers across 11 countries.
Bottom Line: Diagnostic prostate MRI followed by MRI-guided biopsy, only if warranted, detected significantly more clinically significant prostate cancers while avoiding almost half (71/157) of unnecessary biopsies. Wow. | Kasivisvanathan, N Engl J Med 2018
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