Author's Accepted Manuscript Prospective evaluation of MRI-guided in-bore prostate biopsy versus systematic transrectal ultrasound (TRUS)-guided prostate biopsy in biopsy-naïve men with elevated prostate-specific antigen (PSA) levels Michael Quentin , Dirk Blondin , Christian Arsov , Lars Schimmöller , Andreas Hiester , Erhard Godehardt , Peter Albers , Gerald Antoch , Robert Rabenalt PII: DOI: Reference:
S0022-5347(14)03683-0 10.1016/j.juro.2014.05.090 JURO 11513
To appear in: The Journal of Urology Accepted Date: 16 May 2014 Please cite this article as: Quentin M, Blondin D, Arsov C, Schimmöller L, Hiester A, Godehardt E, Albers P, Antoch G, Rabenalt R, Prospective evaluation of MRI-guided in-bore prostate biopsy versus systematic transrectal ultrasound (TRUS)-guided prostate biopsy in biopsy-naïve men with elevated prostate-specific antigen (PSA) levels, The Journal of Urology® (2014), doi: 10.1016/j.juro.2014.05.090. DISCLAIMER: This is a PDF file of an unedited manuscript that has been accepted for publication. As a service to our subscribers we are providing this early version of the article. The paper will be copy edited and typeset, and proof will be reviewed before it is published in its final form. Please note that during the production process errors may be discovered which could affect the content, and all legal disclaimers that apply to The Journal pertain. All press releases and the articles they feature are under strict embargo until uncorrected proof of the article becomes available online. We will provide journalists and editors with full-text copies of the articles in question prior to the embargo date so that stories can be adequately researched and written. The standard embargo time is 12:01 AM ET on that date.
ACCEPTED MANUSCRIPT
Title page
Prospective evaluation of MRI-guided in-bore prostate biopsy versus systematic
RI PT
transrectal ultrasound (TRUS)-guided prostate biopsy in biopsy-naïve men with elevated prostate-specific antigen (PSA) levels
SC
Michael Quentin1, Dirk Blondin1, Christian Arsov2, Lars Schimmöller1, Andreas Hiester2,
1
M AN U
Erhard Godehardt3, Peter Albers2, Gerald Antoch1, Robert Rabenalt2
Department of Diagnostic and Interventional Radiology
University Dusseldorf, Medical Faculty
Moorenstr. 5; D-40225 Dusseldorf, Germany
2
Department of Urology
Fax: +49 - (0) 211 – 81 16145
TE D
Tel.: +49 - (0) 211 – 81 17752
EP
University Dusseldorf, Medical Faculty Moorenstr. 5; D-40225 Dusseldorf, Germany
3
Fax: +49 - (0) 211 – 81 18676
AC C
Tel.: +49 - (0) 211 - 81 18110
Department of Cardiovascular Surgery, division statistics
University Dusseldorf, Medical Faculty, Moorenstr. 5; D-40225 Dusseldorf, Germany Tel.: +49 (0) 211 - 81 18303
Fax: +49 (0) 211 - 81 18333
ACCEPTED MANUSCRIPT 2 Corresponding Author Quentin, Michael Department of Diagnostic and Interventional Radiology
Moorenstr. 5; D-40225 Dusseldorf, Germany [email protected] Tel.: +49 - (0) 211 – 81 17752
abstract: 246 words including the headings
SC
Word count:
Fax: +49 - (0) 211 – 81 16145
RI PT
University Dusseldorf, Medical Faculty
M AN U
body: 2497 words including the headings (max 2500 words)
Concise: In biopsy-naïve patients with elevated PSA levels the MRI-guided in-bore biopsy enables equally high cancer detection rates with fewer biopsy cores compared to
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the standard systematic transrectal ultrasound-guided biopsy.
AC C
Keywords
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Running Head (50 characters): MRI-guided in-bore vs. TRUS-guided prostate biopsy
Biopsy-naïve patients
MRI-guided in-bore biopsy Prostate cancer Prostate MRI Systematic TRUS-guided biopsy
ACCEPTED MANUSCRIPT 3 Abstract
Prospective evaluation of MRI-guided in-bore prostate biopsy versus systematic
RI PT
transrectal ultrasound (TRUS)-guided prostate biopsy in biopsy-naïve men with elevated prostate-specific antigen (PSA) levels
SC
PURPOSE: MRI-guided biopsies are increasingly used for prostate cancer (PCa)
M AN U
diagnosis. However, there is a lack of well controlled prospective trials to support this treatment method. The aim of this study was to prospectively compare the MRI-guided in-bore biopsy with the standard systematic TRUS-guided biopsy in biopsy naïve men with elevated PSA.
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MATERIALS AND METHODS: Prospective inclusion of 132 biopsy-naïve men (ClinicalTrials.gov, NCT01553838) with elevated PSA (>4 ng/ml). After functional multiparametric MRI at 3-TESLA, patients were referred for a MRI-guided in-bore biopsy
EP
of prostate lesions (maximum three) followed by a standard systematic TRUS-guided biopsy (12 cores). Analysis of detection rates for PCa and significant PCa was
AC C
performed (>5 mm total cancer length or any Gleason pattern >3). RESULTS: 128 patients (age 66.1±8.1 years; median PSA 6.7 ng/ml, lower quartile 5.1 ng/ml, upper quartile 9.0 ng/ml) met all study requirements. Both biopsy methods produced the same detection rate of 53.1% (for significant PCa: TRUS-biopsy 79.4%; MRI-guided biopsy 85.3%). 7.8% of clinically significant PCa were missed by the MRIguided in-bore biopsy and 9.4% by the TRUS-biopsy. MRI-guided in-bore biopsy required significantly less cores (p5 mm or any Gleason pattern >3 in the biopsy core.
Statistical analysis
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2.5.
Statistical analysis was performed using SAS Software for Windows (SAS, Cary, NC, USA). The data were tested for normal distribution using the Kolmogorov–Smirnov
EP
test. Normally distributed parameters were compared between the two groups (TRUS-
AC C
guided biopsy or MRI-guided in-bore biopsy) using the t-test for independent groups. Non-parametric data were tested using the Mann–Whitney U test. Normally distributed data was expressed as mean ± SD and other data as median with interquartile range. Statistical significance was defined at a p-value below 0.05.
ACCEPTED MANUSCRIPT
3.
Results
3.1.
Patients’ characteristics
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10
From 132 prospectively enrolled patients, four patients did not have evaluable MRI examinations due to severe artifacts and were excluded.
SC
In total, 128 patients were included and treated in accordance with the study protocol (Table 1). Five patients were receiving treatment with 5α-reductase inhibitors at
prostate for benign prostate hyperplasia.
M AN U
the time of biopsy. Another three patients received prior transurethral resection of the
In 128 patients, 329 different lesions were defined (mean 2.6 lesions per patient). The mean PI-RADS sum-sore of all lesions was 10.5±2.3, for patients with
TE D
PCa 12.3±2.1 (n=78), and for patients with clinically significant PCa 12.7±2.0 (n=67).
EP
The mean time required for the MRI-guided in bore biopsy was 39.0±9.9 minutes. Following both biopsy procedures, one patient (1%) was hospitalized for
3.2.
AC C
prostatitis.
Combined detection rates
Combined targeted MRI-guided in-bore biopsy and systematic TRUS-guided biopsy detected 78 PCa in the 128 patients (detection rate 60.9%). Gleason score distribution was as follows: Gleason score 3+3 (n=16), 3+4 (n=32), 4+3 (n=16), 4+4 (n=10), and 4+5
ACCEPTED MANUSCRIPT 11 (n=4), respectively. From 78 detected PCa, 64 (82.1%) were clinically significant. There was no significant difference in age (p=0.09) or PSA value (p=0.08)
RI PT
between patients with PCa in the biopsy and those without (Table 2). However,
3.3.
Detection rate with either method
SC
prostate volume (p
S0022-5347(14)03683-0 10.1016/j.juro.2014.05.090 JURO 11513
To appear in: The Journal of Urology Accepted Date: 16 May 2014 Please cite this article as: Quentin M, Blondin D, Arsov C, Schimmöller L, Hiester A, Godehardt E, Albers P, Antoch G, Rabenalt R, Prospective evaluation of MRI-guided in-bore prostate biopsy versus systematic transrectal ultrasound (TRUS)-guided prostate biopsy in biopsy-naïve men with elevated prostate-specific antigen (PSA) levels, The Journal of Urology® (2014), doi: 10.1016/j.juro.2014.05.090. DISCLAIMER: This is a PDF file of an unedited manuscript that has been accepted for publication. As a service to our subscribers we are providing this early version of the article. The paper will be copy edited and typeset, and proof will be reviewed before it is published in its final form. Please note that during the production process errors may be discovered which could affect the content, and all legal disclaimers that apply to The Journal pertain. All press releases and the articles they feature are under strict embargo until uncorrected proof of the article becomes available online. We will provide journalists and editors with full-text copies of the articles in question prior to the embargo date so that stories can be adequately researched and written. The standard embargo time is 12:01 AM ET on that date.
ACCEPTED MANUSCRIPT
Title page
Prospective evaluation of MRI-guided in-bore prostate biopsy versus systematic
RI PT
transrectal ultrasound (TRUS)-guided prostate biopsy in biopsy-naïve men with elevated prostate-specific antigen (PSA) levels
SC
Michael Quentin1, Dirk Blondin1, Christian Arsov2, Lars Schimmöller1, Andreas Hiester2,
1
M AN U
Erhard Godehardt3, Peter Albers2, Gerald Antoch1, Robert Rabenalt2
Department of Diagnostic and Interventional Radiology
University Dusseldorf, Medical Faculty
Moorenstr. 5; D-40225 Dusseldorf, Germany
2
Department of Urology
Fax: +49 - (0) 211 – 81 16145
TE D
Tel.: +49 - (0) 211 – 81 17752
EP
University Dusseldorf, Medical Faculty Moorenstr. 5; D-40225 Dusseldorf, Germany
3
Fax: +49 - (0) 211 – 81 18676
AC C
Tel.: +49 - (0) 211 - 81 18110
Department of Cardiovascular Surgery, division statistics
University Dusseldorf, Medical Faculty, Moorenstr. 5; D-40225 Dusseldorf, Germany Tel.: +49 (0) 211 - 81 18303
Fax: +49 (0) 211 - 81 18333
ACCEPTED MANUSCRIPT 2 Corresponding Author Quentin, Michael Department of Diagnostic and Interventional Radiology
Moorenstr. 5; D-40225 Dusseldorf, Germany [email protected] Tel.: +49 - (0) 211 – 81 17752
abstract: 246 words including the headings
SC
Word count:
Fax: +49 - (0) 211 – 81 16145
RI PT
University Dusseldorf, Medical Faculty
M AN U
body: 2497 words including the headings (max 2500 words)
Concise: In biopsy-naïve patients with elevated PSA levels the MRI-guided in-bore biopsy enables equally high cancer detection rates with fewer biopsy cores compared to
TE D
the standard systematic transrectal ultrasound-guided biopsy.
AC C
Keywords
EP
Running Head (50 characters): MRI-guided in-bore vs. TRUS-guided prostate biopsy
Biopsy-naïve patients
MRI-guided in-bore biopsy Prostate cancer Prostate MRI Systematic TRUS-guided biopsy
ACCEPTED MANUSCRIPT 3 Abstract
Prospective evaluation of MRI-guided in-bore prostate biopsy versus systematic
RI PT
transrectal ultrasound (TRUS)-guided prostate biopsy in biopsy-naïve men with elevated prostate-specific antigen (PSA) levels
SC
PURPOSE: MRI-guided biopsies are increasingly used for prostate cancer (PCa)
M AN U
diagnosis. However, there is a lack of well controlled prospective trials to support this treatment method. The aim of this study was to prospectively compare the MRI-guided in-bore biopsy with the standard systematic TRUS-guided biopsy in biopsy naïve men with elevated PSA.
TE D
MATERIALS AND METHODS: Prospective inclusion of 132 biopsy-naïve men (ClinicalTrials.gov, NCT01553838) with elevated PSA (>4 ng/ml). After functional multiparametric MRI at 3-TESLA, patients were referred for a MRI-guided in-bore biopsy
EP
of prostate lesions (maximum three) followed by a standard systematic TRUS-guided biopsy (12 cores). Analysis of detection rates for PCa and significant PCa was
AC C
performed (>5 mm total cancer length or any Gleason pattern >3). RESULTS: 128 patients (age 66.1±8.1 years; median PSA 6.7 ng/ml, lower quartile 5.1 ng/ml, upper quartile 9.0 ng/ml) met all study requirements. Both biopsy methods produced the same detection rate of 53.1% (for significant PCa: TRUS-biopsy 79.4%; MRI-guided biopsy 85.3%). 7.8% of clinically significant PCa were missed by the MRIguided in-bore biopsy and 9.4% by the TRUS-biopsy. MRI-guided in-bore biopsy required significantly less cores (p5 mm or any Gleason pattern >3 in the biopsy core.
Statistical analysis
TE D
2.5.
Statistical analysis was performed using SAS Software for Windows (SAS, Cary, NC, USA). The data were tested for normal distribution using the Kolmogorov–Smirnov
EP
test. Normally distributed parameters were compared between the two groups (TRUS-
AC C
guided biopsy or MRI-guided in-bore biopsy) using the t-test for independent groups. Non-parametric data were tested using the Mann–Whitney U test. Normally distributed data was expressed as mean ± SD and other data as median with interquartile range. Statistical significance was defined at a p-value below 0.05.
ACCEPTED MANUSCRIPT
3.
Results
3.1.
Patients’ characteristics
RI PT
10
From 132 prospectively enrolled patients, four patients did not have evaluable MRI examinations due to severe artifacts and were excluded.
SC
In total, 128 patients were included and treated in accordance with the study protocol (Table 1). Five patients were receiving treatment with 5α-reductase inhibitors at
prostate for benign prostate hyperplasia.
M AN U
the time of biopsy. Another three patients received prior transurethral resection of the
In 128 patients, 329 different lesions were defined (mean 2.6 lesions per patient). The mean PI-RADS sum-sore of all lesions was 10.5±2.3, for patients with
TE D
PCa 12.3±2.1 (n=78), and for patients with clinically significant PCa 12.7±2.0 (n=67).
EP
The mean time required for the MRI-guided in bore biopsy was 39.0±9.9 minutes. Following both biopsy procedures, one patient (1%) was hospitalized for
3.2.
AC C
prostatitis.
Combined detection rates
Combined targeted MRI-guided in-bore biopsy and systematic TRUS-guided biopsy detected 78 PCa in the 128 patients (detection rate 60.9%). Gleason score distribution was as follows: Gleason score 3+3 (n=16), 3+4 (n=32), 4+3 (n=16), 4+4 (n=10), and 4+5
ACCEPTED MANUSCRIPT 11 (n=4), respectively. From 78 detected PCa, 64 (82.1%) were clinically significant. There was no significant difference in age (p=0.09) or PSA value (p=0.08)
RI PT
between patients with PCa in the biopsy and those without (Table 2). However,
3.3.
Detection rate with either method
SC
prostate volume (p
