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Bending the Curve Trial by Trial
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PROMIS

Diagnostic accuracy of multi-parametric MRI and TRUS biopsy in prostate cancer (PROMIS): a paired validating confirmatory study

N = 740NCT01292291

Population
Men with PSA up to 15 ng/mL and no previous biopsy (740 enrolled; 576 had MRI, TRUS biopsy and TPM biopsy).
Design
Multicentre, paired-cohort, confirmatory diagnostic study (not randomised): men with PSA up to 15 ng/mL and no previous biopsy had 1.5 Tesla multi-parametric MRI followed by both TRUS biopsy and template prostate mapping (TPM) biopsy, the reference test; each test was conducted and reported blind to the others. Enrolment May 2012 to November 2015.
Arms
  • TRUS biopsy (control): Transrectal ultrasonography-guided biopsy (all men also had MRI and TPM biopsy)
  • Multi-parametric MRI (experimental): 1.5 Tesla multi-parametric MRI (all men also had TRUS biopsy and TPM biopsy)
People
Ahmed HU, PROMIS study group
Δ Diagnostic sensitivity+45 pointsΔ Diagnostic specificity−55 points
Show the numbers
Results reported for PROMIS
EndpointAnalysisMulti-parametric MRITRUS biopsyEffect
Diagnostic sensitivityMen who had MRI, TRUS biopsy and TPM biopsy (576); clinically significant cancer in 230 (40%)Sensitivity for clinically significant cancer (Gleason score 4+3 or higher, or maximum cancer core length 6 mm or longer) against template prostate mapping biopsy.primaryAhmed 201793% (88–96%)48% (42–55%)P<0.0001Paired comparison of MRI with TRUS biopsy; 408 (71%) of 576 men had cancer on TPM biopsy.
Diagnostic specificityMen who had MRI, TRUS biopsy and TPM biopsy (576)Specificity for clinically significant cancer (Gleason score 4+3 or higher, or maximum cancer core length 6 mm or longer) against template prostate mapping biopsy.primaryAhmed 201741% (36–46%)96% (94–98%)P<0.0001
Results reported for PROMIS
EndpointAnalysisMulti-parametric MRITRUS biopsyEffect
Diagnostic sensitivityMen who had MRI, TRUS biopsy and TPM biopsy (576); clinically significant cancer in 230 (40%)Sensitivity for clinically significant cancer (Gleason score 4+3 or higher, or maximum cancer core length 6 mm or longer) against template prostate mapping biopsy.primaryAhmed 201793% (88–96%)48% (42–55%)P<0.0001Paired comparison of MRI with TRUS biopsy; 408 (71%) of 576 men had cancer on TPM biopsy.
Diagnostic specificityMen who had MRI, TRUS biopsy and TPM biopsy (576)Specificity for clinically significant cancer (Gleason score 4+3 or higher, or maximum cancer core length 6 mm or longer) against template prostate mapping biopsy.primaryAhmed 201741% (36–46%)96% (94–98%)P<0.0001
Primary publication: Ahmed HU, El-Shater Bosaily A, Brown LC, Gabe R, Kaplan R, Parmar MK, et al. Diagnostic accuracy of multi-parametric MRI and TRUS biopsy in prostate cancer (PROMIS): a paired validating confirmatory study. Lancet. 2017;389(10071):815-822. PubMedDOI

Appears in

Sources

  1. Ahmed HU, El-Shater Bosaily A, Brown LC, Gabe R, Kaplan R, Parmar MK, et al. Diagnostic accuracy of multi-parametric MRI and TRUS biopsy in prostate cancer (PROMIS): a paired validating confirmatory study. Lancet. 2017;389(10071):815-822.

    PubMedDOI