Is a 12-core biopsy still necessary, in addition to a targeted biopsy, in patients with a previous negative prostate biopsy and a suspicious lesion on MRI? "Beyond the Abstract," by Art R. Rastinehad, DO

BERKELEY, CA ( - Urologists are faced with many clinical dilemmas in practice. One common clinical dilemma occurs when a patient presents after an initial negative prostate biopsy with an ongoing suspicion for prostate cancer due to abnormal digital rectal exam and/or rising serum PSA. Approximately 50% of all men who have a negative biopsy go on to have a repeat prostate biopsy. In order to properly select men for repeat biopsy, certain genetic tests and biomarkers have been shown to have a high negative predictive value to possibly exclude men from having a repeat biopsy.[1] However, these tests are limited by a low sensitivity/specificity and an inability to overcome the sampling limitations associated with the non-targeted standard transrectal ultrasound-guided prostate biopsy.[2, 3]

We evaluated the use of mpMRI to help select men at risk of prostate cancer and also utilized this information to overcome the inherent limitations associated with the standard ultrasound technology. This was accomplished by using new MR/US fusion-guided biopsy technology (UroNav, Invivo Healthcare a Philips Healthcare Company, Netherlands) to allow for a targeted biopsy of suspicious areas observed on MRI. We also compared the difference in diagnostic accuracy of a fusion-guided biopsy to the standard prostate biopsy. The highlights of the research are as follows:

  • Patients with a suspicious MRI were 3.5 times (65% vs 18%) more likely to have cancer diagnosed when compared to historical cohorts of men undergoing repeat transrectal ultrasound-guided prostate biopsies.[1]
  • MR US fusion-guided biopsy detected more clinically significant prostate cancer when compared to the standard biopsy.
  • In these patients, the incidence of clinically significant disease was substantially higher than what is expected with standard US-guided biopsies when one compares data from the ERSPC and PLCO trials.[4, 5]

Even with all the positive attributes of mpMRI and fusion biopsy technology, it is extremely important to understand that this technology is in its early stages of implementation. Several urologists have contacted researchers regarding this technology and have stated they are unable to attain these results. Patients and physicians need to understand that high quality mpMRI of the prostate with an experienced reader are paramount to obtaining these results. The next important step is performing the fusion biopsy which also requires an experienced skill set. We do recommend the clinical team is involved at all levels of care to allow the radiologist to develop his skill set and the urologist to review his technique to optimize the work flow.

In summary, MR/US fusion biopsy holds great promise as a new process in improving cancer detection rates in patients with a suspicious mpMRI and a prior negative prostate biopsy. The prostate mpMRI is not a substitute for a biopsy and the standard 12-core biopsy does add some clinical utility to the targeted approach. As the data, technology, and physician skills set mature, we believe that imaging and fusion biopsy may play an ever-increasing role in the care of men at risk for prostate cancer.


  1. Roehl KA, Antenor JA, Catalona WJ. Serial biopsy results in prostate cancer screening study. J Urol 2002; 167: 2435–9
  2. Salami SS, Ben-Levi E, Yaskiv O. In patients with a previous negative prostate biopsy and a suspicious lesion on MRI, is a 12-core biopsy still necessary in addition to a targeted biopsy?. BJU Int. 2014 Sep 23. doi: 10.1111/bju.12938
  3. Sciarra A, Panebianco V, Cattarino S. Multiparametric magnetic resonance imaging of the prostate can improve the predictive value of the urinary prostate cancer antigen 3 test in patients with elevated prostate-specific antigen levels and a previous negative biopsy. BJU Int. 2012 Dec;110(11):1661-5.
  4. Pinsky PF, Black A, Parnes HL, Grubb R. Prostate cancer specific survival in the Prostate, Lung, Colorectal, and Ovarian (PLCO) Cancer Screening Trial. Cancer Epidemiol. 2012 Dec;36(6):e401-6.
  5. Schröder FH, Hugosson J, Roobol MJ, ERSPC Investigators. Prostate-cancer mortality at 11 years of follow-up. N Engl J Med. 2012 Mar 15;366(11):981-90.

Written by:
Art R. Rastinehad, DO as part of Beyond the Abstract on This initiative offers a method of publishing for the professional urology community. Authors are given an opportunity to expand on the circumstances, limitations etc... of their research by referencing the published abstract.

Associate Professor of Radiology and Urology
Icahn School of Medicine at Mount Sinai
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In patients with a previous negative prostate biopsy and a suspicious lesion on MRI, is a 12-core biopsy still necessary in addition to a targeted biopsy? - Abstract

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