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In group 2, the MPMRI was positive in 37 pts (44%) with 58% sensitivity, 60% specificity, 29% PPV and 83% NPV. PC found in 54% of the MPMRI positive group with 55%, 35%, and 10% for Gleason 6, 7, and >8, respectively. In pts with > 2 prior negative biopsies, detection of PC was independent of MPMRI status (p¼0.166). On the other hand, a positive MPMRI was associated with detection of high grade PC (HGPC) and/or clinically significant PC (p¼0.0009 and p¼ 0.002, respectively). In group 3, 34/85 pts (40%) had both PCA3 and MPMRI were positive. PC was diagnosed in 59% (23/34) compared to only 5% in pts with both negative tests, group 4 (p¼0.019, sensitivity 86% and NPV 95%). A negative MPMRI missed 23% of PCs, while a negative PCA3, missed 17.6% of PCs at TRUSBX. An AUC of 0.743 was estimated for the BCM. This value increased to 0.794 with the addition of PCA3 and to 0.804 when MPMRI is added. The best discrimination (AUC 0.839, 95% CI 0.779e0.898) was obtained using the full model (BCM + PCA3 and MPMRI). When correlating both test to the post RadP pathology in 32 pts, 21/ 32 (66%) had positive PCA3. A positive PCA3 was not statistically correlated with PC diagnosis (p¼0.128). Yet, a positive PCA3 was associated with a HGPC at final pathology in pts diagnosed with PC (p¼0.0435). On the other hand, MPMRI was positive in 15/21 (71%) with a significance to show both PC and HGPC, p¼ 0.049 and 0.028 respectively. CONCLUSIONS: In patients with more than two prior negative biopsies and persistently elevated PSA, our results highlight the limitation of these novel diagnostic tools among this challenging group of patients to detect PC even when compared to the post RadP pathology findings. Nevertheless, the NPVs for PCA3 and MPMRI were significant. Source of Funding: none
MP53-13 AN UPDATE ON HOSPITAL ADMISSION RATES FOR UROLOGICAL COMPLICATIONS AFTER TRANSRECTAL ULTRASOUND GUIDED PROSTATE BIOPSY Alaina Garbens*, Chris Wallis, Refik Saskin, Ying Liu, Robert Nam, Toronto, Canada INTRODUCTION AND OBJECTIVES: We were the first to report in 2010 rising rates of complications following transrectal ultrasound (TRUS) guided prostate biopsy for prostate cancer detection from 1996-2005. Many centers have since confirmed these findings. We conducted a follow-up study from 2006 to 2013 to further examine these rates. METHODS: This was a retrospective, population based study of 61,910 men who underwent TRUS guided biopsy of the prostate in Ontario, Canada between January 1 2006 and December 31 2013. Using the Canadian Institute of Health Information (CIHI) Registry, the Ontario Health Insurance Plan (OHIP) fee codes and the Ontario Cancer Care Registry, we were able to determine mortality rates and hospital admission rates within 30-days post TRUS prostate biopsy for hematuria, urinary obstruction and genitourinary infection. RESULTS: In total, 61,910 men underwent a TRUS guided prostate biopsy from 2006 to 2013. The overall mortality rate from TRUS biopsy was 0.08% and did not change throughout the study. In total, 30,914 (49.9%) men were diagnosed with prostate cancer and 30,996 (49.9%) men did not have prostate cancer. We focused only on the healthy men with no cancer from biopsy. The 30-day hospital admission rate was 3.45% for men without prostate cancer. Among them, 76.5% (1,128/1,460) patients were admitted due to infection. The rates of 30-day hospital admission due to infection did not significantly increase from 2006 to 2013 (p¼0.74). The adjusted odds ratio for admission for infection was 1.21 (95% CI 0.38 to 3.89) for patients from 2013, compared to patients in 2006. The number of
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TRUS biopsies performed annually remained stable and then abruptly fell by 30.6% in 2013 compared to the average annual biopsy rate. The rate of hospital admission in 2013, however, remained the same at 4.1% (compared to 4.0% in 2006). There were no significant differences in admission rates for age or socioeconomic status from multivariable analysis. CONCLUSIONS: The 30-day post TRUS biopsy hospital admission rates remained stable for the duration of the study. The hospital admission rate was 4.1% in 2013, which was the exact same as the admission rate in 2005 from our previous study. However, these rates are still higher than the initial baseline rate of 1% in 1996. Interestingly, we witnessed an abrupt drop in biopsy rates in 2013, which could be due to the recent U.S. Preventative Services Task Force (USPSTF) recommendation against PSA screening. Source of Funding: Ajmera Family Chair in Urologic Oncology
MP53-14 COST EFFECTIVENESS OF MAGNETIC RESONANCE/ ULTRASOUND FUSION PROSTATE BIOPSY VS STANDARD OF CARE (TRANSRECTAL ULTRASOUND (TRUS)-GUIDED BIOPSY) Kaitlan Cobb*, Washington, DC; Amichai Kilchevsky, Bethesda, MD; John Michael DiBianco, Washington, DC; Daniel Su, Thomas Frye, Bethesda, MD; Vikram Sabarwal, Washington, DC; Baris Turkbey, Peter Choyke, Bradford Wood, Peter Pinto, Bethesda, MD INTRODUCTION AND OBJECTIVES: Studies have shown magnetic resonance imaging / ultrasound (MR/US) fusion prostate biopsies to be to be comparable and superior to standard TRUS-guided biopsy in diagnosing prostate cancer (PCa). MRI of the prostate as a possible initial diagnostic tool has been postulated. We sought to explore the cost-effectiveness of prostate MRI as an initial diagnostic tool as compared to TRUS-guided biopsy. METHODS: Using a cost analysis model, the total cost and outcomes for biopsy naïve men presenting with an elevated PSA >4.0 ng/ml was compared. A theoretical cohort was subdivided into those undergoing TRUS prostate biopsy and those undergoing prostate MRI with subsequent MR/US fusion biopsy only if when a target lesion is present. A cancer incidence of 28%, additional 32% non-infectious complication rate cost, 1.73% infectious complication cost, sensitivities and specificities for TRUS-guided biopsy at 53% and 66% respectively, prostate MRI set at 75% and 88% respectively and MR/US fusion biopsy set at 77% and 68% respectively, were based off current literature. Cost of TRUS biopsy, prostate MRI and MR/US fusion biopsy were based of the current AUA recommended CPT and Medicare reimbursement. Added cost for the MR/US fusion cohort included the system cost, determined by the average cost of the commercially available system. RESULTS: Using a total cost for 1 patient undergoing TRUS prostate biopsy of $1,410.35, a contrast enhanced prostate MR of $633.36 and MRI fusion biopsy of $2,138.95, TRUS guided biopsy in 100 men would cost $141,035, and would be falsely negative in 13.16 men and falsely positive 24.48 men. The total cost of obtaining initial prostate MRI in 100 men with only patients with target lesion(s) undergoing MR/US fusion biopsy, was determined to be $107,961.69 given that 70.36 men would undergo prostate MRI alone, and 29. 64 men would have a subsequent MR/US fusion biopsy. Within the group of men only undergoing prostate MRI, 7 men would have falsely negative results and 8.64 would have falsely positive results. If MR/US fusion biopsy were performed without the addition of the standard 12core template, false positivity would occur in 0.521 men, and false negativity in 6.44 men. CONCLUSIONS: 100 men with PSA elevation who undergo prostate MRI with MR/US fusion biopsy if indicated, would cost ~25% less than undergoing an initial standard TRUS guided biopsy. Prostate MRI alone would result in fewer biopsies performed, thereby decreasing the cost of diagnosing PCa and reducing biopsy associated complications.
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Source of Funding: This research was supported by the Intramural Research Program of the National Institutes of Health (NIH), National Cancer Institute, Center for Cancer Research, and the Center for Interventional Oncology. NIH and Philips Healthcare have a cooperative research and development agreement. NIH and Philips share intellectual property in the field. This research was also made possible through the National Institutes of Health Medical Research Scholars Program, a public-private partnership supported jointly by the NIH and generous contributions to the Foundation for the NIH from Pfizer Inc., The Doris Duke Charitable Foundation, The Alexandria Real Estate Equities, Inc. and Mr. and Mrs. Joel S. Marcus, and the Howard Hughes Medical Institute, as well as other private donors. For a complete list, please visit the Foundation website at: http://fnih.org/work/education-training0/medical-research-scholars-program
MP53-15 MULTI-INSTITUTIONAL ASSESSMENT OF MULTIPARAMETRIC MRI AND FUSION BIOPSY OF THE PROSTATE IN A BIOPSY-NA€IVE POPULATION Arvin George, Meet Kadakia*, Bethesda, MD; Minhaj Siddiqui, College Park, MD; Soroush Rais-Bahrami, Birmingham, AL; Ardeshir Rastinehad, New Hyde Park, NY; Srinivas Vourganti, Syracuse, NY; Michele Fascelli, Michael Kongnyuy, Akhil Muthigi, Abhinav Sidana, Amichai Kilchevsky, Thomas Frye, Daniel Su, Bethesda, MD; John Thomas, Vidhush Yarlagadda, Vidhush Yarlagadda, Birmingham, AL; Maria Merino, Peter Choyke, Baris Turkbey, Bradford Wood, Peter Pinto, Bethesda, MD INTRODUCTION AND OBJECTIVES: Multiparametric MRI (mpMRI) and fusion biopsy (FB) have demonstrated proven benefit in patients with a prior negative systematic biopsy (SB) or diagnosis of prostate cancer (CaP). Its value in patients with no prior history of prostate biopsy is less defined. We aim to evaluate mpMRI and FB in a biopsy naive population. METHODS: A multi-institutional review was performed on patients with no prior biopsy history who underwent mpMRI followed by FB and SB in the same session. Imaging protocol and image interpretation with the previously validated NIH suspicion scoring system was standardized across institutions. MpMRI and pathology was reviewed by respective institutional genitourinary radiologists and pathologists. CaP risk groupings by Gleason Score (GS) were defined as low (GS 6, low volume GS 3+4¼7), intermediate (high volume GS 3+4¼7), and high (GS4+3). Univariate analysis was performed to compare performance of FB versus SB. RESULTS: A total of 395 biopsy naive men were identified from 4 participating institutions. Mean age and PSA were 62.3 years (8.4) and 7.0ng/ml (5.8), respectively. Patient characteristics, GS and risk classification distribution for FB and SB are presented in Table 1. Overall cancer detection rate (CDR) was 65.0%. In biopsy naive men, FB detected a greater absolute number of high risk CaP than SB (22.3% vs 20.3%). Additionally, FB detected 18% fewer cases of GS 6 CaP (15.7% vs 19.2%, p¼0.1). The CDR for FB alone was 57.2% with only 4 intermediate risk and 1 high risk patient not identified. The addition of SB to FB resulted in the diagnosis of 26 additional cases of low risk disease for each case of high risk CaP detected. The CDR of SB alone was 59.2%, however, 1 intermediate and 4 high risk CaP were missed. The addition of FB to SB alone resulted in only 4.5 additional cases of low risk CaP for each high risk CaP detected. CONCLUSIONS: In men with no prior biopsy history, mpMRI and fusion biopsy detects a greater proportion of high risk disease while decreasing the detection of low risk CaP. As urologists explore ways to apply this technology in their practice, additional studies with greater power will be required to validate the potential benefit of mpMRI and FB in the biopsy naive population.
Source of Funding: This research was supported by the Intramural Research Program of the National Institutes of Health (NIH), National Cancer Institute, Center for Cancer Research, and the Center for Interventional Oncology. NIH and Philips Healthcare have a cooperative research and development agreement. NIH and Philips share intellectual property in the field. This research was also made possible through the National Institutes of Health Medical Research Scholars Program, a public-private partnership supported jointly by the NIH and generous contributions to the Foundation for the NIH from Pfizer Inc., The Doris Duke Charitable Foundation, The Alexandria Real Estate Equities, Inc. and Mr. and Mrs. Joel S. Marcus, and the Howard Hughes Medical Institute, as well as other private donors. For a complete list, please visit the Foundation website at: http://fnih.org/work/education-training0/medical-research-scholars-program
MP53-16 OUTCOMES AND SAFETY PROFILE OF TRANSPERINEAL PROSTATE BIOPSY: RESULTS FROM THE VICTORIAN TRANSPERINEAL BIOPSY COLLABORATION Sean Huang*, Declan Murphy, Homayoun Zargar, Sarah Mann, Douglas Tjandra, Wee Loon Ong, Daniel Moon, Nathan Lawrentschuk, Mark Frydenberg, Jeremy Grummet, Melbourne, Australia INTRODUCTION AND OBJECTIVES: Transperineal prostate biopsy (TPB) has been proposed as a safer and more sensitive method for obtaining prostate gland biopsy. Herein we review the indications, outcomes and safety profile of TPB utilising our prospective Victorian Transperineal Biopsy Collaboration (VTBC) database. METHODS: The VTBC is a multi-institutional registry collecting data prospectively from four contributing institutions across Melbourne, Australia. The database is ethics approved at each institution and data collected is based on the minimum dataset published by the Ginsburg Study Group. RESULTS: The total of 1108 men underwent TPB between June 2010 and June, with 870 having adequate histological data for analysis. The indications for TPB were primary biopsy (43.4%), repeat biopsy in the setting of previous negative TRUS biopsy (18.3%) and confirmatory biopsy for men on active surveillance (35.6%). The mean cohort age was 63.5 (SD 7.8) and median pre-biopsy PSA was 6.5 (IQR 4.7 - 9.7). In 388 men undergoing TPB as initial biopsy, 328/388 (84.5%) were diagnosed with prostate cancer and 215/388 (55.4%) were diagnosed with Gleason ¼ 7 disease. In 164 men with a prior negative TRUS biopsy, 51/164 (31.1%) were found to have prostate cancer and 35/164 (21.3%) were diagnosed with Gleason ¼ 7 disease. Of 318 patients on active surveillance, 137/318 (43%) were upstaged to Gleason ¼ 7 disease. Overall 230 (25.7%) men were diagnosed with an anterior tumour. The overall rate of acute urinary retention was 3.2%. Only 3(0.3%) patients in the cohort required hospital admission due to biopsy related infection. CONCLUSIONS: The VTBC is the largest reported database of patients having TPB in Australia and New Zealand. The current results