in men with suspicion of prostate cancer (PCa), the standard for cancer detection is trans-rectal ultrasound guided (TRUS) 10-12-core systematic biopsy (SB). Performing a targeted biopsy (TB) only strategy, using MRI-TRUS image registration, is gaining in popularity. Our objective was to assess the non-inferiority of TB versus SB.
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between June-October 2014, 108 biopsy-naïve patients with PSA between 4-20 ng/mL, normal rectal examination, and a single suspicious image on MRI, were included in seven centers. Patients underwent SB by a first operator blinded to MRI, immediately followed by three TB within the suspicious image, by a second operator. Primary endpoint was cancer detection rate. Non-inferiority margin was set at -5%. Secondary endpoints were detection rate of clinically significant cancer (csPCa) (maximum cancer core length≥5 mm for Gleason 6 or any Gleason≥7 disease), and procedure duration.
SB and TB detected cancer in 66 (61.1%) and 61 (56.5%) patients respectively. The mean difference was of -4.5% with a lower bound of 95% CI of -11.8%. Thirteen patients with protocols violations were excluded of the per-protocol analysis, which showed a mean difference of -5.2% with a lower bound of 95% CI of -13.1%. A csPCa was detected in 50 (46.2%) and 52 (48.1%) patients with SB and TB, respectively (p=0.69). Mean (sd) duration of image fusion plus TB was 16.7 (7) minutes, versus 7.4 (3) minutes for SB (p<0.001).
TB seemed to be inferior to SB for overall cancer detection. Detection of csPCa was not different between TB and SB.
The Journal of urology. 2016 Apr 11 [Epub ahead of print]
Nicolas Barry Delongchamps, Daniel Portalez, Eric Bruguière, Olivier Rouvière, Bernard Malavaud, Pierre Mozer, Gaelle Fiard, François Cornud, MURIELLE study group
Cochin University Hospital, Department of Urology, Paris Descartes University, France; Inserm Unit U1151, Paris Descartes University, France. Electronic address: ., Rangueil University Hospital, Toulouse, France., Clinique Pasteur, Toulouse, France., Hospices Civils de Lyon, Department of Urinary and Vascular Radiology, Edouard Herriot Hospital, Lyon, F-69437, France; University Lyon 1, France. 9-Pitié Salpêtrière University Hospital, Pierre et Marie Curie University, Paris, France., Rangueil University Hospital, Toulouse, France., Hospices Civils de Lyon, Department of Urinary and Vascular Radiology, Edouard Herriot Hospital, Lyon, F-69437, France; University Lyon 1, France. 9-Pitié Salpêtrière University Hospital, Pierre et Marie Curie University, Paris, France., Grenoble University Hospital, Grenoble, France., Cochin University Hospital, Department of Urology, Paris Descartes University, France.