PMID- 31519516
OWN - NLM
STAT- MEDLINE
DCOM- 20200720
LR  - 20200720
IS  - 2588-9311 (Electronic)
IS  - 2588-9311 (Linking)
VI  - 2
IP  - 6
DP  - 2019 Nov
TI  - Complications and Adverse Events of Three Magnetic Resonance Imaging-based Target 
      Biopsy Techniques in the Diagnosis of Prostate Cancer Among Men with Prior 
      Negative Biopsies: Results from the FUTURE Trial, a Multicentre Randomised 
      Controlled Trial.
PG  - 617-624
LID - S2588-9311(19)30133-6 [pii]
LID - 10.1016/j.euo.2019.08.007 [doi]
AB  - BACKGROUND: Three techniques of magnetic resonance imaging (MRI)-based targeted 
      biopsy (TB) of the prostate exist. There is no superiority regarding diagnostic 
      efficacy of prostate cancer (PCa) detection. OBJECTIVE: To compare adverse events 
      (AEs) among three TB techniques and to evaluate the effect on urinary and 
      erectile function. DESIGN, SETTING, AND PARTICIPANTS: Post hoc analysis of a 
      multicentre randomised controlled trial among men with negative systematic biopsy 
      (SB) and suspicion of PCa. INTERVENTION: In 234 patients, 3-T multiparametric MRI 
      demonstrated PIRADS>/= 3 lesions, and patients were randomised 1:1:1 for TB: 
      transrectal in-bore MRI TB (MRI-TB), transperineal MRI-transrectal ultrasound 
      (TRUS) fusion TB (FUS-TB), and transrectal cognitive TRUS TB (COG-TB). OUTCOME 
      MEASUREMENTS AND STATISTICAL ANALYSIS: AEs (Clavien-Dindo) were compared using 
      Pearson chi-square test. Univariate logistic regression tests were performed for 
      the number of cores, biopsy approach, and usage of anticoagulants. The 
      participants filled in baseline and 30-d postbiopsy International Prostate 
      Symptom Score (IPSS) and International Index of Erectile Function (IIEF-5) 
      questionnaires. The delta between measurements was compared using one-way 
      analysis of variance. RESULTS AND LIMITATIONS: There were significant differences 
      in minor AEs: 53% in MRI-TB, 71% in FUS-TB, and 85% in COG-TB (p < 0.001). The 
      number of cores was associated with AEs (odds ratio [OR] 1.11 per extra biopsy 
      [95% confidence interval CI 1.06-1.17, p < 0.001]). Anticoagulants were not 
      associated with bleeding complications (OR 1.24 [95% CI 0.66-2.35, p = 0.5]). 
      Transrectal approach (MRI-TB + COG-TB) increased the risk of any AE (OR 2.54 [95% 
      CI 1.16-5.77, p < 0.05]) and nonsignificantly increased the risk of urinary tract 
      infections (OR 3.69 [95% CI 0.46-168.4, p = 0.3]). Biopsy did not impact urinary 
      (DeltaIPSS 0.3, p = 0.1) and erectile function (DeltaIIEF-5 -0.4, p = 0.5). The main 
      limitation was that additional SB was performed in FUS-TB and COG-TB, and was 
      omitted in MRI-TB, making comparison difficult. CONCLUSIONS: There was a 
      significant difference in minor AEs among groups. An increase in the number of 
      cores increased the overall risk of AEs. A low AE occurrence in MRI-TB was likely 
      caused by the omission of SB. Prostate biopsy did not impact self-reported 
      urinary and erectile functions. PATIENT SUMMARY: In this study, we compared the 
      complication rates of three techniques of magnetic resonance imaging (MRI)-based 
      targeted biopsy of the prostate. We found a significant difference in the 
      occurrence of minor complication rates among three groups in favour of 
      transrectal in-bore MRI targeted biopsy, likely caused by the omission of 
      additional systematic biopsy in this group.
CI  - Copyright (c) 2019 European Association of Urology. Published by Elsevier B.V. All 
      rights reserved.
FAU - Wegelin, Olivier
AU  - Wegelin O
AD  - Department of Urology, St. Antonius Hospital, Nieuwegein/Utrecht, The 
      Netherlands. Electronic address: o.wegelin@antoniusziekenhuis.nl.
FAU - Exterkate, Leonie
AU  - Exterkate L
AD  - Department of Urology, Canisius Wilhelmina Hospital, Nijmegen, The Netherlands.
FAU - van der Leest, Marloes
AU  - van der Leest M
AD  - Department of Radiology and Nuclear Medicine, Radboudumc, Nijmegen, The 
      Netherlands.
FAU - Kelder, Johannes C
AU  - Kelder JC
AD  - Department of Epidemiology, St. Antonius Hospital, Nieuwegein/Utrecht, The 
      Netherlands.
FAU - Bosch, J L H Ruud
AU  - Bosch JLHR
AD  - Department of Urology, UMC, Utrecht, The Netherlands.
FAU - Barentsz, Jelle O
AU  - Barentsz JO
AD  - Department of Radiology and Nuclear Medicine, Radboudumc, Nijmegen, The 
      Netherlands.
FAU - Somford, Diederik M
AU  - Somford DM
AD  - Department of Urology, Canisius Wilhelmina Hospital, Nijmegen, The Netherlands.
FAU - van Melick, Harm H E
AU  - van Melick HHE
AD  - Department of Urology, St. Antonius Hospital, Nieuwegein/Utrecht, The 
      Netherlands.
LA  - eng
PT  - Journal Article
PT  - Multicenter Study
PT  - Randomized Controlled Trial
PT  - Research Support, Non-U.S. Gov't
DEP - 20190911
PL  - Netherlands
TA  - Eur Urol Oncol
JT  - European urology oncology
JID - 101724904
SB  - IM
MH  - Aged
MH  - Humans
MH  - Image-Guided Biopsy/*adverse effects/methods
MH  - Magnetic Resonance Imaging/*adverse effects/methods
MH  - Male
MH  - Prostatic Neoplasms/*complications/*diagnosis/pathology
OTO - NOTNLM
OT  - Complications
OT  - Erectile dysfunction
OT  - Lower urinary tract symptoms
OT  - Magnetic resonance imaging
OT  - Prostate biopsy
OT  - Targeted biopsy
EDAT- 2019/09/15 06:00
MHDA- 2020/07/21 06:00
CRDT- 2019/09/15 06:00
PHST- 2019/06/12 00:00 [received]
PHST- 2019/07/28 00:00 [revised]
PHST- 2019/08/12 00:00 [accepted]
PHST- 2019/09/15 06:00 [pubmed]
PHST- 2020/07/21 06:00 [medline]
PHST- 2019/09/15 06:00 [entrez]
AID - S2588-9311(19)30133-6 [pii]
AID - 10.1016/j.euo.2019.08.007 [doi]
PST - ppublish
SO  - Eur Urol Oncol. 2019 Nov;2(6):617-624. doi: 10.1016/j.euo.2019.08.007. Epub 2019 
      Sep 11.