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Bending the Curve Trial by Trial
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PRECISION

MRI-Targeted or Standard Biopsy for Prostate-Cancer Diagnosis

N = 500NCT02380027

Population
Men with a clinical suspicion of prostate cancer (raised PSA level or abnormal digital rectal examination; PSA 20 ng/mL or lower; no extracapsular disease on examination) who had not undergone biopsy previously, at 25 centres in 11 countries (full text).
Design
Multicentre, randomised, noninferiority trial: men with a clinical suspicion of prostate cancer and no previous biopsy were assigned to MRI, with a targeted biopsy (without standard cores) only if the MRI was suggestive of cancer, or to a standard 10-to-12-core transrectal ultrasonography-guided biopsy.
Primary endpoint
Detection of clinically significant prostate cancer
Arms
  • Standard biopsy (control, n = 248): 10-to-12-core transrectal ultrasonography-guided biopsy
  • MRI, targeted biopsy if suggestive (experimental, n = 252): MRI with targeted biopsy (no standard cores) if the MRI was suggestive of prostate cancer; no biopsy otherwise
People
Kasivisvanathan V, PRECISION Study Group Collaborators
Δ Detection of clinically significant prostate cancer+12 points
Show the numbers
Results reported for PRECISION
EndpointAnalysisMRI, targeted biopsy if suggestiveStandard biopsyEffect
Detection of clinically significant prostate cancerIntention-to-treat: all randomised men (252 MRI-targeted biopsy group; 248 standard-biopsy group)Proportion of men receiving a diagnosis of clinically significant cancer, defined in the full text as a single biopsy core with Gleason score 3+4 (Gleason sum 7) or greater.primaryKasivisvanathan 201838%26%P=0.00595 of 252 vs 64 of 248; adjusted difference 12 percentage points (95% CI 4-20). MRI with or without targeted biopsy was noninferior to standard biopsy, and the confidence interval indicated superiority. In the MRI-targeted group 71 of 252 men (28%) had MRI results not suggestive of cancer and did not undergo biopsy. Clinically insignificant cancer (secondary): adjusted difference -13 percentage points (95% CI -19 to -7; P<0.001), arm percentages not given in the abstract; the full text gives 23 men (9%) vs 55 (22%), clinically insignificant defined as Gleason score 3+3.
Results reported for PRECISION
EndpointAnalysisMRI, targeted biopsy if suggestiveStandard biopsyEffect
Detection of clinically significant prostate cancerIntention-to-treat: all randomised men (252 MRI-targeted biopsy group; 248 standard-biopsy group)Proportion of men receiving a diagnosis of clinically significant cancer, defined in the full text as a single biopsy core with Gleason score 3+4 (Gleason sum 7) or greater.primaryKasivisvanathan 201838%26%P=0.00595 of 252 vs 64 of 248; adjusted difference 12 percentage points (95% CI 4-20). MRI with or without targeted biopsy was noninferior to standard biopsy, and the confidence interval indicated superiority. In the MRI-targeted group 71 of 252 men (28%) had MRI results not suggestive of cancer and did not undergo biopsy. Clinically insignificant cancer (secondary): adjusted difference -13 percentage points (95% CI -19 to -7; P<0.001), arm percentages not given in the abstract; the full text gives 23 men (9%) vs 55 (22%), clinically insignificant defined as Gleason score 3+3.
Primary publication: Kasivisvanathan V, Rannikko AS, Borghi M, Panebianco V, Mynderse LA, Vaarala MH, et al. MRI-Targeted or Standard Biopsy for Prostate-Cancer Diagnosis. N Engl J Med. 2018;378(19):1767-1777. PubMedDOI

Appears in

Sources

  1. Kasivisvanathan V, Rannikko AS, Borghi M, Panebianco V, Mynderse LA, Vaarala MH, et al. MRI-Targeted or Standard Biopsy for Prostate-Cancer Diagnosis. N Engl J Med. 2018;378(19):1767-1777.

    PubMedDOI