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| October 17, 2015

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Attachments:Magnetic Resonance Imaging-Ultrasound Fusion Targeted
Prostate Biopsy in a Consecutive Cohort of Men with No
Previous Biopsy: Reduction of Over Detection through
Improved Risk Stratification
Neil Mendhiratta, Andrew B. Rosenkrantz, Xiaosong Meng, James S. Wysock,
Michael Fenstermaker, Richard Huang, Fang-Ming Deng, Jonathan Melamed,*
Ming Zhou, William C. Huang, Herbert Lepor and Samir S. Taneja†
From the School of Medicine (NM, MF) and Departments of Radiology (ABR, SST), Surgery (XM), Urology (RH, WCH, HL, SST) and
Pathology (FMD, JM, MZ), New York University Langone Medical Center, New York and Department of Urology, New York Hospital
Queens (JSW), Flushing, New York
Purpose: MRF-TB (magnetic resonance imaging-ultrasound fusion targeted
prostate biopsy) may improve the detection of prostate cancer in men presenting
for prostate biopsy. We report clinical outcomes of 12-core systematic biopsy and
MRF-TB in men who presented for primary biopsy and further describe
pathological characteristics of cancers detected by systematic biopsy and not by
MRF-TB.
Materials and Methods: Clinical outcomes of 435 consecutive men who underwent
prebiopsy multiparametric magnetic resonance imaging followed by MRFTB
and systematic biopsy at our institution between June 2012 and March 2015
were captured in an institutional review board approved database. Clinical
characteristics, biopsy results and magnetic resonance imaging suspicion scores
were queried from the database.
Results: Prostate cancer was detected in 200 of 370 men (54.1%) with a mean
 SD age of 64  8.5 years and mean  SEM prostate specific antigen 6.8 
0.3 ng/ml who met study inclusion criteria. The cancer detection rate of systematic
biopsy and MRF-TB was 47.3% and 43.5%, respectively (p ¼ 0.104).
MRF-TB detected more Gleason score 7 or greater cancers than systematic biopsy
(114 of 128 or 89.1% vs 95 of 128 or 74.2%, p ¼ 0.008). Of 39 cancers detected
by systematic biopsy but not by MRF-TB 32 (82.1%) demonstrated Gleason
6 disease, and 24 (61.5%) and 32 (82.1%) were clinically insignificant by Epstein
criteria and a UCSF CAPRA (University of California-San Francisco-Cancer of
the Prostate Risk Assessment) score of 2 or less, respectively.
Conclusions: In men presenting for primary prostate biopsy MRF-TB detects
more high grade cancers than systematic biopsy. Most cancers detected by systematic
biopsy and not by MRF-TB are at clinically low risk. Prebiopsy magnetic
resonance imaging followed by MRF-TB decreases the detection of low risk
cancers while significantly improving the detection and risk stratification of high
grade disease.
Key Words: prostatic neoplasms, magnetic resonance imaging,
ultrasonography, biopsy, diagnostic imaging
Abbreviations
and Acronyms
CDR ¼ cancer detection rate
GS ¼ Gleason score
mpMRI ¼ multiparametric MRI
MRGB ¼ MRI guided targeted
biopsy
MRI ¼ magnetic resonance
imaging
mSS ¼ maximum MRI suspicion
score
PCa ¼ prostate cancer
PSA ¼ prostate specific antigen
SB ¼ systematic biopsy
US ¼ ultrasound
Accepted for publication June 7, 2015.
Study received institutional review board
approval.
* Financial interest and/or other relationship
with the Department of Defense.
† Correspondence: Division of Urologic
Oncology, Department of Urology, New York
University Langone Medical Center, 150 East
32nd St., Suite 200, New York, New York 10016
(telephone: 646-825-6321; FAX: 646-825-6399;
e-mail: samir.taneja@nyumc.org).
Editor’s Note: This article is the
of 5 published in this issue for
which category 1 CME credits
can be earned. Instructions for
obtaining credits are given with
the questions on pages and
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Dochead: Adult Urology FLA 5.4.0 DTD  JURO12718_proof  14 September 2015  10:44 am  EO: JU-15-801
0022-5347/15/1946-0001/0
THE JOURNAL OF UROLOGY®
 2015 by AMERICAN UROLOGICAL ASSOCIATION EDUCATION AND RESEARCH, INC.
http://dx.doi.org/10.1016/j.juro.2015.06.078
Vol. 194, 1-6, December 2015
Printed in U.S.A. www.jurology.com j 1
PROSTATE cancer is the most common cancer diagnosed
in men in the United States and the second
most common cause of cancer death.1 Traditional
US guided prostate biopsy has been shown to have
limited sensitivity for detecting PCa.2,3 Consequently
an initial biopsy negative for PCa often does
not reliably indicate absent disease.4 Additionally in
light of the increasing number of prostate biopsies
performed due to increased PSA5 the rate of over
detection of clinically low risk disease varies from
2% to 67% of cancer diagnoses,6 leading to unnecessary
morbidity associated with over treatment
and decreased quality of life.7,8
Current evidence demonstrates improved
sensitivity for detecting high grade PCa using
mpMRI followed by MRI targeted biopsy than
with standard 12-core systematic biopsy.9e12 We
compared the outcomes of targeted prostate biopsy
performed with automated MRI-US fusion and
12-core SB done with a computerized template in
the population of men with increased PSA and no
history of prostate biopsy. In light of recent
evidence suggesting that MRI targeted biopsy
selectively identifies high grade cancer compared
to SB13 we further characterized cancers that were
missed or mischaracterized as low grade by
MRF-TB alone.
MATERIALS AND METHODS
Study Design and Population
Between June 2012 and March 2015, 625 consecutive men
with no prior biopsy who presented to our institution for
prostate biopsy were offered prebiopsy mpMRI. No abnormality
was identified in 88 (14.1%) of these men. Of
the remaining 537 men 435 (81.0%) proceeded combined
MRF-TB and SB. Clinical data mSS and biopsy results
were recorded in an institutional review board approved
½F1 database (fig. 1). Some men were excluded from analysis,
including 15 who underwent MRI with a nonstandard
prostate MRI protocol and 50 in whom the prebiopsy
mpMRI was not read according to standardized trial
reporting criteria.
Multiparametric MRI
mpMRI was performed using a 3 Tesla whole body system
and a pelvic phased array coil. It included multiplanar
turbo-spin echo T2-weighted images, axial single shot
echo-planar imaging diffusion-weighted imaging with
b-values of 50 and 1,000 seconds per mm2
, and dynamic
contrast enhanced imaging MRI after intravenous
administration of gadolinium chelate. Before biopsy MRI
studies were reviewed by a single fellowship trained
radiologist with 5 to 6 years of experience with prostate
MRI at the time of this study to identify suspicious foci in
the prostate. The probability of tumor was scored on a
5-point Likert scale, including mSS 2dlow probability,
3dequivocal, 4dhigh probability and 5dvery high probability
as previously reported.10,14,15 Studies with no
identified suspicious region received a score of 1 and were
not candidates for MRI targeted biopsy.
MRI-US Fusion Targeted Biopsy
MRF-TB was done with the Artemis ProFuse coregistration
system for mpMRI segmentation, coregistration
of MRI to US images and 3-dimensional
biopsy planning as described in our previous study.10
Briefly lesion boundaries were identified by the radiologist
on T2-weighted images and transferred to the Artemis
system for guidance during the biopsy procedure. Computer
assisted co-registration of segmented MRI and US images
of the prostate was performed by manual rigid translation
followed by automated elastic deformation.With the patient
in the left lateral decubitus position transrectal biopsies
were obtained beginning with 4 biopsy cores targeted to
each suspicious lesion identified on MRI and followed by
12-core computerized template biopsy with core locations
designated by the Artemis generated template. Procedures
were done using the Pro Focus or Noblus (Hitachi Aloka
Medical America, Wallingford, Connecticut) US system,
an end fire probe, a reusable biopsy gun, 18 gauge needles
and local anesthesia with 1% lidocaine infiltration.
For each patient all systematic and targeted biopsies
were performed by the same 1 of 4 faculty physicians with
expertise in prostate biopsy. All biopsy cores were
analyzed by specialized genitourinary pathologists at the
same single institution.
Data Analysis and Statistics
Biopsy results were compared using the highest GS obtained
by each technique. Determination of high grade
cancer was based on GS 7 or greater. Clinically insignifi-
cant cancer was assessed using Epstein criteria16 and a
UCSF CAPRA score of 2 or less.17 Other comparative data
points included the number of biopsy cores demonstrating
cancer, cancer core length per core and the percent of
Gleason pattern 4 disease.
Figure 1. Patient enrollment
2 MAGNETIC RESONANCE IMAGING-ULTRASOUND FUSION TARGETED PROSTATE BIOPSY
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Dochead: Adult Urology FLA 5.4.0 DTD  JURO12718_proof  14 September 2015  10:44 am  EO: JU-15-801
All analysis was done in SPSS, version 21.0.
Categoric variable comparisons were performed with the
chi-square test and continuous variables were evaluated
with the Student t-test. Comparison of cancer detection
rates between techniques was assessed by the McNemar
test.
RESULTS
A total of 370 men met study inclusion criteria.
½T1 Table 1 lists additional patient characteristics.
Overall Cancer Detection
PCa was identified in 200 men (54.1%). The CDR of
SB and MRF-TB was 47.3% and 43.5%, respectively
(p ¼ 0.104). GS 7 or greater cancer was detected
½T2 in 128 men (34.6%). Table 2 lists the CDRs of GS
6 and 7 or greater disease for each biopsy technique.
MRF-TB detected more GS 7 or greater cancers
than SB (114 of 128 or 89.1% vs 95 of 128 or 74.2%,
p ¼ 0.008). MRF-TB contributed to a 35% increase
in GS 7 or greater PCa detection compared to SB
while SB contributed to an 11% increase in GS 7 or
greater PCa detection compared to MRF-TB. Eight
of the 14 GS 7 or greater cancers (57%) detected by
SB that were missed or graded as GS 6 by MRF-TB
demonstrated minimal pattern 4 (GS 3 þ 4) disease
in only 1 SB core. MRF-TB diagnosed more GS 7 or
greater disease using fewer cores per prostate than
½T3 SB (table 3).
Detection of Clinically Low Risk Disease
While SB detected more cancers than MRF-TB,
32 of 39 cancers (82.1%) detected by SB but not by
MRF-TB were GS 6 while 24 of 39 (61.5%) and 32
of 39 (82.1%) were clinically insignificant by Epstein
criteria16 and a UCSF CAPRA score of 2 or less,17
respectively. In contrast 8 of 25 cancers (32.0%)
detected by MRF-TB but not by SB showed
GS 6 cancer, and only 3 (12.0%) and 6 of 25
(24.0%) were clinically insignificant by Epstein16
and UCSF CAPRA17 criteria, respectively.
Consequently compared to cancers detected only by
MRF-TB a higher proportion detected only by SB
were GS 6 (p <0.001), and clinically insignificant by Epstein and UCSF CAPRA criteria (each p <0.001, ½F2 fig. 2).16,17 Table 4 lists descriptive features of ½T4 discordant SB and MRF-TB results. Ultimately SB contributed to the detection of 32 additional GS 6 cancers while detecting only 4 with GS 7 or greater (4 þ 3), or GS 7 (3 þ 4) in more than 1 core missed by MRF-TB. MRI Suspicion Score and PCa Detection Table 5 lists CDRs by mSS. Of 149 men with mSS 4 ½T5 or greater 98 (85.2%) were found to have PCa. In this subgroup of 149 men 102 (68.5%) were found to have GS 7 or greater cancer. MRF-TB did not detect 7 of these 102 cancers (6.9%) and SB did not detect 28 (27.5%) (p <0.001). Of 221 men with mSS 2 or 3 the GS was 7 or greater (3 þ 4) and 7 or greater (4 þ 3) in 25 (11.3%) and 8 (3.6%), respectively. In 6 of these 17 men (35.3%) GS 7 (3 þ 4) cancers and in 0 of 8 (0%) GS 7 or greater (4 þ 3) cancers were missed or classified as GS 6 by MRF-TB. Of 27 cancers detected by SB that were not detected by MRF-TB in men with mSS 2 or 3, 16 (59.3%) and 22 (81.5%) were clinically insignificant by Epstein16 and UCSF CAPRA17 criteria, respectively. Using a cutoff of mSS 4 or greater the sensitivity, specificity, and negative and positive predictive values for detecting GS 7 or greater PCa with combined MRF-TB and SB were 79.7%, 87.1%, 88.7% and 68.5%, respectively. DISCUSSION The goals of prostate biopsy in men with clinical suspicion of PCa have changed in recent years. Table 1. Patient demographics No. pts 370 Mean  SD age 64.6  8.5 Mean  SEM PSA (ng/ml) 6.8  0.3 Median cc MRI prostate vol (IQR) 46 (36e62) No. MRI abnormalities (%): 1 232 (62.7) 2 118 (31.9) 3 18 (4.9) 4 2 (0.5) No. mSS (%): 2 108 (29.2) 3 113 (30.5) 4 77 (20.8) 5 72 (19.5) Table 2. Comparative outcomes of MRF-TB and SB SB No. MRF-TB (%) Gleason 7 or Greater Gleason 6 No Ca Total No. GS 7 or greater 81 (21.9) 7 (1.9) 7 (1.9) 95 (25.7)* GS 6 16 (4.3) 32 (8.6) 32 (8.6) 80 (21.6)† No Ca 17 (4.6) 8 (2.2) 170 (46.0) 195 (52.7) Totals 114 (30.8)* 47 (12.7)† 209 (56.5) 370 (100) * p ¼ 0.008. † p < 0.001. Table 3. Biopsy characteristics by technique MRF-TB SB Mean No. biopsy cores: Per prostate 5.7 12.0 To diagnose 1 GS 7 or greater Ca 18.4 46.7 No. max GS (%): No Ca 209 (56.5) 195 (52.7) 3 þ 3 47 (12.7) 80 (21.6) 3 þ 4 58 (15.7) 41 (11.1) 4 þ 3 or Greater 56 (15.1) 54 (14.6) MAGNETIC RESONANCE IMAGING-ULTRASOUND FUSION TARGETED PROSTATE BIOPSY 3 229 230 231 232 233 234 235 236 237 238 239 240 241 242 243 244 245 246 247 248 249 250 251 252 253 254 255 256 257 258 259 260 261 262 263 264 265 266 267 268 269 270 271 272 273 274 275 276 277 278 279 280 281 282 283 284 285 286 287 288 289 290 291 292 293 294 295 296 297 298 299 300 301 302 303 304 305 306 307 308 309 310 311 312 313 314 315 316 317 318 319 320 321 322 323 324 325 326 327 328 329 330 331 332 333 334 335 336 337 338 339 340 341 342 Dochead: Adult Urology FLA 5.4.0 DTD  JURO12718_proof  14 September 2015  10:44 am  EO: JU-15-801 While cancer detection remains of paramount importance, there is a growing desire to decrease the detection of indolent, potentially nonlethal cancers.18 Various biomarkers and imaging techniques are available that aim to discriminate men with regard to the risk of high grade cancer but the optimal implementation of these tools in clinical practice remains unclear.19,20 Recent evidence has supported prebiopsy MRI to improve the detection of high risk cancer in men who present for a first prostate biopsy.21 In our cohort of men without previous biopsy prebiopsy mpMRI followed by MRFTB provided overall better detection of high grade cancer than SB while limiting the detection of cancer with low risk features. Mozer et al reported the outcomes of comparing MRF-TB with extended 12-core systematic biopsy in men with no previous biopsies.22 In a cohort of 152 men overall CDR was lower for MRF-TB than for SB (54% vs 57%) as we noted in our study. There was almost no difference in the detection of GS 7 or greater cancers between the 2 techniques in their biopsy results (21.7% vs 22.4%). However, when categorized as clinically significant disease (at least 1 core with GS 3 or greater þ 4 or 6 with a maximum cancer core length o f4 mm or greater) vs clinically insignificant disease, MRF-TB detected more significant cancers than SB (43.4% vs 36.8%). Delongchamps et al also reported outcomes of prebiopsy MRI and targeted biopsy vs standard transrectal biopsy in 391 men who presented for the first biopsy.23 Of 264 men who underwent targeted biopsy using rigid or elastic co-registration of MRI and US images targeted biopsy demonstrated higher GS 7 or greater cancer detection than standard biopsy. In these 2 groups but not in the visual co-registration group targeted biopsy also yielded higher overall cancer detection than standard biopsy. Pokorny et al reported the results of MRGB vs standard transrectal biopsy in biopsy naive men.11 Of 142 men with abnormal mpMRI, defined as a PI-RADS (Prostate Imaging Reporting and Data System) score of 3 or greater, PCa was detected by standard biopsy in 101 (71.1%) vs 99 (69.7%) by MRGB. However, MRGB detected more high risk cancer than standard biopsy (65.5% vs 52.1%). When interpreting the published literature on MRI targeted biopsy, critical concepts regarding the value of targeted biopsy should be considered. Past series have shown higher overall CDR than ours,11,22,23 which may suggest differences in the underlying prevalence and stage of disease among tested cohorts. The relative added benefit of MRI targeting likely varies with cancer prevalence as SB is more likely to identify cancer in men with high prevalence and more advanced stage of disease. Additionally the definitions of clinical significance currently reported are to some extent arbitrary with inadequate correlation with eventual disease outcome. In this regard reporting standards can greatly influence the outcome of the study and inflate the perceived impact of targeting. While to our knowledge previously reported measures of clinical significance have not been validated in the setting of MRI targeted biopsy, we used several of these definitions to better illustrate the significance of disease. To our knowledge this study represents the largest reported cohort of biopsy naive men undergoing MRI-US software fusion targeted and 12-core systematic prostate biopsy. This analysis was Table 4. Discordant results between MRF-TB and SB Max GS Detected No. Pts No. Max GS (%) No. Max SB Core Ca (%) No. mSS (%) 6 7 (3 þ 4) 7 (4 þ 3) 8 or Greater 10% or Less 10%e50% 50% or Greater 2 or 3 4 or 5 By SB vs MRF-TB: 46 32 (70) 8 (17) 5 (11) 1 (2) 19 (41) 18 (39) 9 (20) 30 (65) 16 (35) 7 or Greater vs 6 7 e 4 (57) 3 (43) 0 1 (14) 2 (29) 4 (57) 3 (43) 4 (57) 7 or Greater vs neg 7 e 4 (57) 2 (29) 1 (14) 2 (29) 4 (57) 1 (14) 3 (53) 4 (57) 6 vs neg 32 32 (100) ee e 16 (50) 12 (38) 4 (12) 24 (75) 8 (25) By MRF-TB vs SB: 41 8 (20) 19 (46) 7 (17) 7 (17) 5 (12) 4 (10) 32 (78) 11 (27) 30 (73) 7 or Greater vs 6 16 e 12 (75) 3 (19) 1 (6) 0 3 (19) 13 (81) 1 (6) 15 (94) 7 or Greater vs neg 17 e 7 (41) 4 (24) 6 (35) 1 (6) 1 (6) 15 (88) 3 (18) 14 (82) 6 vs Neg 8 8 (100) ee e 4 (50) 0 4 (50) 7 (88) 1 (12) Figure 2. PCa missed by MRF-TB and SB. Asterisk indicates MRF-TB vs SB detection of GS 6 cancer p <0.001. 4 MAGNETIC RESONANCE IMAGING-ULTRASOUND FUSION TARGETED PROSTATE BIOPSY 343 344 345 346 347 348 349 350 351 352 353 354 355 356 357 358 359 360 361 362 363 364 365 366 367 368 369 370 371 372 373 374 375 376 377 378 379 380 381 382 383 384 385 386 387 388 389 390 391 392 393 394 395 396 397 398 399 400 401 402 403 404 405 406 407 408 409 410 411 412 413 414 415 416 417 418 419 420 421 422 423 424 425 426 427 428 429 430 431 432 433 434 435 436 437 438 439 440 441 442 443 444 445 446 447 448 449 450 451 452 453 454 455 456 Dochead: Adult Urology FLA 5.4.0 DTD  JURO12718_proof  14 September 2015  10:44 am  EO: JU-15-801 intended to investigate differences between cancers detected by traditional 12-core SB and by MRF-TB using an MRI-US fusion platform in men with mpMRI visualized lesions suspicious for PCa and use the information derived to inform biopsy practice. By yielding a lower rate of overall cancer detection but a higher rate of GS 7 or greater cancer detection compared to SB our outcomes of MRF-TB reflect the trends reported in other MRI guided prostate biopsy trials. They also demonstrate a significant reduction in low risk PCa detection with MRF-TB. Because the problem of over detection of low risk disease by traditional biopsy methods has prompted an effort to selectively identify high risk PCa, an approach is to consider the relative contribution of SB to MRF-TB outcomes. A larger proportion of PCa detected by MRF-TB was found to be high grade compared to that detected by SB, including 20% diagnosed as low grade by SB and 17 men in whom SB detected no cancer. Importantly we noted that 62% to 82% of PCa detected by SB and missed by MRF-TB in biopsy naive men were likely to be clinically insignificant. Conversely as few as 12% of PCas detected by MRF-TB and not by SB were clinically insignifi- cant. Even among GS 7 or greater PCas detected by SB that were missed or graded as GS 6 by MRFTB most lesions demonstrated a minimal Gleason pattern 4 component, suggesting that these men represent the lower end of the spectrum of intermediate risk. Had all men in this study undergone MRF-TB alone, the detection of up to 32 clinically insignificant cancers would have been avoided and only 4 cancers with GS 7 or greater (4 þ 3) or GS 7 (3 þ 4) in more than 1 core would have been missed among 370 men. Additionally by considering the relative contribution of SB in men stratified by mSS it may be possible to further optimize the balance between high grade PCa detection and avoidance of low risk disease. Of 32 clinically insignificant cancers detected by SB and missed by MRF-TB 22 (68.8%) were detected in men with mSS less than 4. Only 3 GS 7 or greater cancers were detected by SB alone in this subgroup of 221 men. Therefore, prebiopsy MRI followed by targeted biopsy and avoidance of systematic biopsy in select men, especially those with mSS 2 or 3, may provide the greatest potential to limit the detection of low risk cancer while maximizing the detection of high grade disease. This study benefited from institutional experience with prostate MRI, the fact that all mpMRIs were interpreted and scored by a single experienced radiologist and the standardized biopsy approach performed by a few experienced operators. Limitations of our study include the potential for selection bias, given its retrospective nature and the referral pattern of our practice. We believe that the consecutive nature of our cohort to an extent minimizes the possibility of bias as men were largely referred based on community screening practices. Additionally our conclusions regarding disease risk are based purely on biopsy and were not validated by prostatectomy. Due to current practices of selectively offering prostatectomy to patients at higher risk such a study may not be feasible. Disease risk in our study was defined based on risk stratification methods derived from systematic biopsy. As such they may not be valid in the setting of MRF-TB. Despite this we believe they offer the best known means to assess risk in the biopsy setting. Finally because outcomes of biopsy in men with normal MRI were not included in this analysis, the impact of avoiding biopsy in those men could not be measured in our study. However, based on our early experience suggesting a high negative predictive value of normal MRI24 we believe that the likelihood of missing significant disease in this population is low. Despite the inherent limitations of our analysis we strongly believe that the outcomes of this study support the practice of prebiopsy MRI followed by selective targeted biopsy as a tool to maximize the identification of high grade cancer and limit the detection of indolent disease in the group of men with abnormal MRI. CONCLUSIONS In men with increased PSA who present for initial prostate biopsy prebiopsy mpMRI followed by MRF-TB in those with suspicious MRI limits over detection of clinically insignificant PCa while providing greater detection of clinically significant PCa than SB alone. The majority of PCas detected by SB but missed by MRF-TB represent clinically insignificant disease based on several definitions. mpMRI provides added ability to predict the risk of GS 7 or greater cancer with a negative predictive value of 89% for detecting GS 7 or greater disease Table 5. Cancer detection rate by mSS mSS (approach) No. Pts No. Max GS (%) 7 or Greater 6 No. Neg (%) 4 or 5: 149 102 (68.5) 25 (16.8) 22 (14.8) MRF-TB 95 (63.8)* 20 (13.4) 34 (22.8) SB 74 (49.7)* 38 (25.5) 37 (24.8) 2 or 3: 221 26 (11.8) 47 (21.3) 148 (67.0) MRF-TB 19 (8.6) 27 (12.2)† 175 (79.2) SB 21 (9.5) 42 (19.0)† 158 (71.5) *MRF-TB vs SB p <0.001. †MRF-TB vs SB p ¼ 0.003. MAGNETIC RESONANCE IMAGING-ULTRASOUND FUSION TARGETED PROSTATE BIOPSY 5 457 458 459 460 461 462 463 464 465 466 467 468 469 470 471 472 473 474 475 476 477 478 479 480 481 482 483 484 485 486 487 488 489 490 491 492 493 494 495 496 497 498 499 500 501 502 503 504 505 506 507 508 509 510 511 512 513 514 515 516 517 518 519 520 521 522 523 524 525 526 527 528 529 530 531 532 533 534 535 536 537 538 539 540 541 542 543 544 545 546 547 548 549 550 551 552 553 554 555 556 557 558 559 560 561 562 563 564 565 566 567 568 569 570 Dochead: Adult Urology FLA 5.4.0 DTD  JURO12718_proof  14 September 2015  10:44 am  EO: JU-15-801 in men with a maximum mSS of 2/3 and a positive predictive value of 69% in men with a maximum mSS of 4/5. Prebiopsy mpMRI is an effective tool for further risk stratification in men with clinical suspicion of prostate cancer and no previous biopsy. REFERENCES 1. Siegel R, Ma J, Zou Z et al: Cancer statistics, 2014. CA Cancer J Clin 2014; 64: 9. 2. Wright JL and Ellis WJ: Improved prostate cancer detection with anterior apical prostate biopsies. Urol Oncol 2006; 24: 492. 3. Levine MA, Ittman M, Melamed J et al: Two consecutive sets of transrectal ultrasound guided sextant biopsies of the prostate for the detection of prostate cancer. J Urol 1998; 159: 471. 4. Abraham NE, Mendhiratta N and Taneja SS: Patterns of repeat prostate biopsy utilization in contemporary clinical practice. J Urol 2015; 193: 1178. 5. Carlsson S, Vickers AJ, Roobol M et al: Prostate cancer screening: facts, statistics, and interpretation in response to the US Preventive Services Task Force review. J Clin Oncol 2012; 30: 2581. 6. Loeb S, Vellekoop A, Ahmed HU et al: Systematic review of complications of prostate biopsy. Eur Urol 2013; 64: 876. 7. Sanda MG, Dunn RL, Michalski J et al: Quality of life and satisfaction with outcome among prostate-cancer survivors. N Engl J Med 2008; 358: 1250. 8. Steineck G, Helgesen F, Adolfsson J et al: Quality of life after radical prostatectomy or watchful waiting. N Engl J Med 2002; 347: 790. 9. Siddiqui MM, Rais-Bahrami S, Truong H et al: Magnetic resonance imaging/ultrasound-fusion biopsy significantly upgrades prostate cancer versus systematic 12-core transrectal ultrasound biopsy. Eur Urol 2013; 64: 713. 10. Wysock JS, Rosenkrantz AB, Huang WC et al: A prospective, blinded comparison of magnetic resonance (MR) imaging-ultrasound fusion and visual estimation in the performance of MR-targeted prostate biopsy: the PROFUS trial. Eur Urol 2013; 66: 343. 11. Pokorny MR, De Rooij M, Duncan E et al: Prospective study of diagnostic accuracy comparing prostate cancer detection by transrectal ultrasound-guided biopsy versus magnetic resonance (MR) imaging with subsequent mr-guided biopsy in men without previous prostate biopsies. Eur Urol 2014; 66: 22. 12. Borkowetz A, Platzek I, Toma M et al: Comparison of systematic transrectal biopsy to transperineal MRI/ultrasound-fusion biopsy for the diagnosis of prostate cancer. BJU Int, Epub ahead of print December 18, 2014. 13. Siddiqui M, Rais-Bahrami S, Turkbey B et al: Comparison of MR/ultrasound fusion-guided biopsywith ultrasound-guided biopsy for the diagnosis of prostate cancer. JAMA 2015; 313: 390. 14. Rosenkrantz AB, Kim S, Lim RP et al: Prostate cancer localization using multiparametric MR imaging: comparison of Prostate Imaging Reporting and Data System (PI-RADS) and Likert scales. Radiology 2013; 269: 482. 15. Rosenkrantz AB, Deng FM, Kim S et al: Prostate cancer: multiparametric MRI for index lesion localizationda multiple-reader study. AJR Am J Roentgenol 2012; 199: 830. 16. Epstein JI, Walsh PC, Carmichael M et al: Pathologic and clinical findings to predict tumor extent of nonpalpable (stage T1c) prostate cancer. JAMA 1994; 271: 368. 17. Cooperberg MR, Pasta DJ, Elkin EP et al: The University of California, San Francisco Cancer of the Prostate Risk Assessment score: a straightforward and reliable preoperative predictor of disease recurrence after radical prostatectomy. J Urol 2005; 173: 1938. 18. Taneja SS, Bjurlin MA, Carter HB et al: White Paper: AUA/Optimal Techniques of Prostate Biopsy and Specimen Handling. Linthicum: American Urological Association 2013. 19. Cuzick J, Thorat MA, Andriole G et al: Prevention and early detection of prostate cancer. Lancet Oncol 2014; 15: e484. 20. Dimakakos A, Armakolas A and Koutsilieris M: Novel tools for prostate cancer prognosis, diagnosis, and follow-up. Biomed Res Int 2014; 2014: 890697. 21. Valerio M, Donaldson I, Emberton M et al: Detection of clinically significant prostate cancer using magnetic resonance imaging-ultrasound fusion targeted biopsy: a systematic review. Eur Urol 2015; 68: 8. 22. Mozer P, Roupr^et M, Le Cossec C et al: First round of targeted biopsies using magnetic resonance imaging/ultrasonography fusion compared with conventional transrectal ultrasonography-guided biopsies for the diagnosis of localised prostate cancer. BJU Int 2015; 115: 50. 23. Delongchamps NB, Peyromaure M, Schull A et al: Prebiopsy magnetic resonance imaging and prostate cancer detection: comparison of random and targeted biopsies. J Urol 2013; 189: 493. 24. Wysock JS, Rosenkrantz AB, Meng X et al: Predictive value of negative 3T multiparametric prostate MRI on 12 core biopsy results. J Urol, suppl., 2014; 191: e754, abstract MP67-14. Research Article Review Be sure to use this format with your answers inserted between each question and to answer all of the questions completely. Article citation: 1. Introduction a. Briefly describe the topic and goals of the research b. Is the past research summarized in a way that conveys the need for the current study? Summarize the most pertinent past research. c. What additional information was the present experiment supposed to add to the field? d. State the study’s hypothesis or hypotheses. If there is no explicitly stated hypothesis, what is the research question or the intention of the study? e. How will the current study change or add to our understanding of the area being investigated? f. Are there any gaps in the logic of the development of the hypotheses and research questions? If so, what? 2. Methods a. Who were the participants? Were the inclusionary and exclusionary criteria on which they were selected appropriate and adequate? b. What experimental groups were included in the study and did they adequately test the research question? c. What was the setting of the study? d. Identify the type of design used and summarize the design. e. List all of the variables. Indicate how they were operationally defined. i. If correlational, indicate which variables were to be associated with one another ii. If experimental, indicate which variables were independent and dependent iii. If not a or b, indicate which variables were investigated f. Were the research participants randomly assigned to conditions? g. Did the study have the necessary control or comparison groups to eliminate the influence of confounding extraneous variables? h. Were there any attempts to control for biases that may arise from experimenter expectancies or research participant perceptions? i. Did the operationalization of the independent and dependent variables seem to have captured the construct being investigated and the construct being measured? 3. Confounds and Ethical Issues a. Indicate whether or not there were any biases present in the selection of participants. If so, how could they have been avoided? b. Indicate whether or not there were any biases present during the running of the study (consider experimental bias, participant bias etc). c. Consider the guidelines of the American Psychological Association. Were the participants at any risk? If so, what safeguards did the researcher institute into the study? d. Did the experimenters obtain the participants’ consent to participate? If so, was it adequate? e. Did you find any ethical issues that were not addressed adequately? If so, describe why you do not think they are adequate and how you would address them. 4. Results a. Were any descriptive statistics used? Which ones? What do they tell you? Are they adequate? b. Were any inferential statistics used? Which ones? What do they tell you? Are they adequate? c. Are the data clearly presented? Evaluate not only the text but also the figures and tables. d. Explain how the results supported or did not support the hypotheses. e. How large was the sample size? Was the sample size large enough to detect an effect, or was it so large that even a very small effect would be statistically significant, but not practically significant? f. Were the data analyzed several different ways and was the rationale for conducting several different data analyses appropriate? g. Did you find any potential biases in how the analyses were done or reported? If so, what? h. Can the results be generalized to other populations and other situations? 5. Discussion a. What major conclusions do the authors draw? b. Do the results provide support for the hypothesis and have they provided an answer to the research question(s) posed? c. Have the findings of the study been related to prior research and the theoretical framework from which they have began? d. Do the conclusions follow logically from the results? Are there any unwarranted hidden assumptions of causality? e. Do the authors suggest any theoretical implications? If so, what? Discuss briefly whether or not you agree with their theoretical interpretations. f. Do the authors suggest any practical implications? If so, what? g. Have the authors discussed possible artifacts of their data? Do you think this experiment was well executed? If not, what were some of the flaws? How might you overcome these flaws in future research? h. To what populations or settings would you be willing to extend or generalize the conclusions? i. What future research do the authors suggest? 6. References a. Are there adequate references to the work of others? b. Are any key references missing? c. Have the authors cited mainly other research articles or is the reference section heavily based on review articles and book chapters? 7. Final comments (include any additional comments you might have about this article).

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