Vol. 199, No.
4S, Supplement, Saturday, May 19, 2018
MP40-09
MOVING TOWARDS ZERO SEPSIS; OUR REGISTRARS CAN DO
IT! AN ANALYSIS OF 214 CASES OF TRANSPERINEAL
PROSTATE BIOPSY OVER THREE YEARS
Hansi Pathirana*, Jonathan Kam, Yuigi Yuminaga, Kieran Beattie,
Sunny Nalavenkata, Mohan Arianayagam, Bertram Canagasingham,
Richard Ferguson, Raymond Ko, Celi Varol, Matthew Winter,
Mohamed Khadra, Kingswood, Australia
INTRODUCTION AND OBJECTIVES: Transperineal (TP) bi-
opsy is an increasingly utilised method of prostate biopsy which is
associated with low rates of sepsis. This is particularly important with
the rise of multi-resistant organisms which make sepsis from standard
trans-rectal prostate biopsy more difficult to prevent and manage. This
study aimed to assess post-operative complications of TP prostate bi-
opsy performed by Urological Trainees at an Australian teaching centre.
METHODS: Institutional review board approval for this project
was granted (HREC File No, 17-27(A)) by the Nepean Blue Mountains
Local Health District Human Research Ethics Committee.Males who
underwent TP biopsy from April 2015 until May 2017 at Nepean Hos-
pital, Kingswood, Australia were included in the study. TP biopsy was
performed with a standard template grid approach, with additional bi-
opsies taken of any suspicious lesions identified on multi-parametric
MRI. Cases received a pre-operative single dose of intravenous
cephazolin as prophylaxis. All cases were followed up for re-presen-
tation to hospital within 30 days of biopsy. The primary outcome was re-
presentation for TP biopsy related complications. Data was analysed
using SPSS 24.0.
RESULTS: A total of 214 males were included with a mean age
of 63.4, PSA 9.4ng/mL and prostate volume of 54.3cc. Overall, twenty-
one cases (9.8%) had hospital re-presentation within 30 days, with bi-
opsy related complications. Thirteen cases (6%) re-presented with uri-
nary retention and five cases (2.3%) experienced haematuria with clot
retention. Five cases (2.3%) developed culture-proven urinary tract in-
fections, with only one of these cases (0.4%) having an associated
fever (but no haemodynamic instability). None of the culture-proven UTI
cases had positive blood cultures or required intensive care unit
admission.
CONCLUSIONS: Our study supports the growing literature
supporting the use of TP biopsy in reducing the rate of urosepsis
following prostate biopsy. With rising rates of multi-drug resistance in
normal rectal flora, this is becoming highly relevant in the arena of
prostate biopsy for cancer diagnosis and active surveillance. At our
centre, TP biopsy has resulted in a 0.4% sepsis rate after 3 years, and
an acceptable hospital representation rate, for acute urinary retention
and clot retention.
Source of Funding: None
MP40-10
EXTENDED VALIDATION RESULTS FROM A PROSPECTIVE
ADAPTIVE UTILITY TRIAL CONFIRM PERFORMANCE OF A
NOVEL URINE EXOSOME GENE EXPRESSION ASSAY TO
PREDICT HIGH-GRADE PROSTATE CANCER AT INITIAL BIOPSY
James McKiernan*, New York City, NY; Michael Donovan, NYC, NY;
Eric Margolis, Englewood, NJ; Alan Partin, H. Ballentine Carter,
Baltimore, MD; Gordon Brown, Sewell, NJ; Phillipp Torkler,
Mikkel Noerholm, Martinsried, Germany; Chris Bentis, Johan Skog,
Waltham, MA; Neal Shore, Myrtle Beach, SC; Ian Thompson, San
Antonio, TX; Gerald Andriole, St. Louis, MO; Peter Carroll, San
Francisco, CA
INTRODUCTION AND OBJECTIVES: The ability to discrimi-
nate indolent from clinically significant prostate cancer (PCa) prior to
initial biopsy remains an important health issue. Diagnostic assays that
have been extensively evaluated in a prospective setting are necessary
for efficacy and clinical adoption. We conducted an extended validation
study to assess outcome and cut-point performance of the ExoDx
THE JOURNAL OF UROLOGYâ e523
Prostate(IntelliScore) (EPI) urine exosome assay vs. standard of care
(SOC) (i.e. prostate-specific antigen [PSA], age, race, and family his-
tory) for discriminating Gleason score (GS)>/¼7(ISUP>/¼2) from GS6
PCa and benign disease on initial biopsy.
METHODS: Phase 1 of a prospective, two cohort, adaptive
clinical implementation and utility study comparing EPI test results with
biopsy outcomes. Eligible subjects: >/¼50-years, PSA 2-10 ng/mL,
scheduled for initial prostate needle biopsy. Test performance is re-
ported using the area under the receiver operating characteristic curve
(AUC), Negative predictive value (NPV), Positive predictive value
(PPV), Sensitivity, and Specificity for discriminating >/¼GS7(ISUP>/
¼2) from GS6 (ISUP1) and benign disease on initial biopsy. Results are
compared to the previous validation study.
RESULTS: Cohort 1: N¼503 patients: Mean age 64 years,
mean PSA 5.6 ng/mL, 14% African American, 70% Caucasian, 53%
positive biopsy rate (22% GS6(ISUP1), 17% GS3+4(ISUP2) and 14%
>GS4+3 (ISUP3). EPI AUC 0.70 superior to SOC AUC 0.62 and PSA
AUC 0.58 for discriminating >/¼GS7 (ISUP>/¼2) PCa from benign and
GS6 (ISUP1) PCa. Comparison to the original validation cohort (n¼519
patients, EPI AUC 0.71) demonstrated good agreement. Using the
previously validated cut-point of 15.6 (or alternative 20) would avoid
26% (or 40%) of unnecessary prostate biopsies and 20% (or 31%) of
total biopsies, with an NPV of 89% for both cut-points, and miss only 7%
(or 11%) of ISUP>2, respectively.
CONCLUSIONS: EPI is a non-invasive, easy to use, first in
class 3-gene expression urine assay, which has now been successfully
validated in over 1000 patients to discriminate high-grade (>/¼GS7,
ISUP>/¼2) from low-grade (GS6, ISUP1) PCa and benign disease. The
test improves identification of patients with higher grade disease and
should reduce the total number of unnecessary biopsies.
Source of Funding: none
MP40-11
USE OF PSA AND 4-KALLIKREIN PANEL TO IDENTIFY LETHAL
PROSTATE CANCERS AND REDUCE UNNECESSARY
SCREENING AND BIOPSY
€ran Hallmans,
Emily Vertosick, Daniel Sjoberg, New York, NY; Go
Umea, Sweden; Andrew Vickers*, Hans Lilja, New York, NY;
€r Stattin, Umea, Sweden
Pa
INTRODUCTION AND OBJECTIVES: While PSA screening
allows early detection of lethal prostate cancers, it has also increased
the detection and treatment of indolent disease. A single, mid-life PSA
has been shown to be predictive of distant metastasis at 30 year follow-
up. In addition, a panel of four kallikrein markers, commercially available
as the 4Kscore, can be used to predict risk of Gleason grade group 2 or
higher (GG2+) cancer in men with elevated PSA, avoiding unnecessary
biopsy and overdiagnosis of GGG1 cancers. We aimed to extend these
findings using the definitive outcome of death from prostate cancer in a
large population-based observational cohort of unscreened
healthy men.
METHODS: We analyzed the association between PSA, the 4-
kallikrein panel and the risk of death from prostate cancer in blood
collected at age 40, 50 and 60 from 45,598 men from the Va € sterbotten
Intervention Project who were followed without screening. Marker levels
were obtained from the cohort biobank using a case-control method-
ology. We assessed the discrimination of PSA and kallikrein panel
measurements at age 50 and 60 for predicting prostate cancer death.
RESULTS: There were 2,425 men diagnosed with prostate
cancer and 172 prostate cancer deaths. PSA was highly associated
with risk of prostate cancer death up to 20 years after measurement (c-
index at age 50: 0.859, 95% CI 0.799, 0.916; age 60: 0.840, 95% CI
0.799, 0.878). The majority of prostate cancer deaths occurred in men
with PSA in the top quartile: 75% and 72%of deaths in men with PSA at
age 50 and 60. Men with PSA below the median (~1 ng / ml) at age 60
had a 20-year risk of prostate cancer death less than 0.4%. In men with
elevated PSA, the kallikrein panel markedly improved discrimination (c-
index 0.767 to 0.828 and from 0.811 to 0.881 in 50 vs 60 year olds).