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Eur Urol. 2016 Jan;69(1):149-56. doi: 10.1016/j.eururo.2015.03.041. Epub 2015 Apr 7.

A Randomized Controlled Trial To Assess and Compare the Outcomes of Two-core Prostate Biopsy Guided by Fused Magnetic Resonance and Transrectal Ultrasound Images and Traditional 12-core Systematic Biopsy.

Author information

1
Department of Urology, Division for Cancer Medicine, Surgery and Transplantation, Oslo University Hospital, Oslo, Norway; University of Oslo, Oslo, Norway. Electronic address: eduard.baco@medisin.uio.no.
2
University of Oslo, Oslo, Norway; Department of Radiology and Nuclear Medicine, Oslo University Hospital, Oslo, Norway.
3
Department of Urology, Division for Cancer Medicine, Surgery and Transplantation, Oslo University Hospital, Oslo, Norway; University of Oslo, Oslo, Norway.
4
Department of Urology, Division for Cancer Medicine, Surgery and Transplantation, Oslo University Hospital, Oslo, Norway.
5
Department of Pathology, Oslo University Hospital, Oslo, Norway.
6
USC Institute of Urology, Keck School of Medicine, University of Southern California, Los Angeles, CA, USA.

Abstract

BACKGROUND:

Prostate biopsy guided by computer-assisted fusion of magnetic resonance imaging (MRI) and transrectal ultrasound (TRUS) images (MRI group) has not yet been compared with 12-core random biopsy (RB; control group) in a randomized controlled trial (RCT).

OBJECTIVE:

To compare the rate of detection of clinically significant prostate cancer (csPCa) between the two groups.

DESIGN, SETTING, AND PARTICIPANTS:

This RCT included 175 biopsy-naïve patients with suspicion for prostate cancer, randomized to an MRI group (n=86) and a control group (n=89) between September 2011 and June 2013.

INTERVENTION:

In the MRI group, two-core targeted biopsy (TB) guided by computer-assisted fusion of MRI/TRUS images of MRI-suspicious lesions was followed by 12-core RB. In the control group, both two-core TB for abnormal digital rectal examination (DRE) and/or TRUS-suspicious lesions and 12-core RB were performed. In patients with normal MRI or DRE/TRUS, only 12-core RB was performed.

OUTCOMES MEASUREMENTS AND STATISTICAL ANALYSIS:

The detection rates for any cancer and csPCa were compared between the two groups and between TB and RB.

RESULTS AND LIMITATIONS:

Detection rates for any cancer (MRI group 51/86, 59%; control group 48/89, 54%; p=0.4) and csPCa (38/86, 44% vs 44/89, 49%; p=0.5) did not significantly differ between the groups. Detection of csPCa was comparable between two-core MRI/TRUS-TB (33/86, 38%) and 12-core RB in the control group (44/89, 49%; p=0.2). In a subset analysis of patients with normal DRE, csPCa detection was similar between two-core MRI/TRUS-TB (14/66, 21%) and 12-core RB in the control group (15/60, 25%; p=0.7). Among biopsy-proven csPCas in MRI group, 87% (33/38) were detected by MRI/TRUS-TB. The definition of csPCa was only based on biopsy outcomes.

CONCLUSION:

Overall csPCa detection was similar between the MRI and control groups. Two-core MRI/TRUS-TB was comparable to 12-core RB for csPCa detection.

PATIENT SUMMARY:

Our randomized controlled trial revealed a similar rate of prostate cancer detection between targeted biopsy guided by magnetic resonance imaging (MRI) and transrectal ultrasound (TRUS) and 12-core random biopsy. The traditional 12-core random biopsy may be replaced by two-core MRI/TRUS targeted biopsy for detection of clinically significant prostate cancer.

KEYWORDS:

Image-guided biopsy; Magnetic resonance imaging; Prostate cancer; Systematic random biopsy; Targeted biopsy; Ultrasonography

PMID:
25862143
DOI:
10.1016/j.eururo.2015.03.041
[Indexed for MEDLINE]
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