1. EMBARGOED FOR RELEASE UNTIL MONDAY, MAY 16, 2011 AT 1:00 P.M.
Contact: Wendy Waldsachs Isett, AUA
410-977-4770, wisett@AUAnet.org
BUILDING A BETTER CANCER TEST: UPDATES ON NEW BIOMARKERS AND GENETIC ASSAYS FOR BLADDER AND
PROSTATE CANCERS
Washington, DC, May 16, 2010—Clinicians treating bladder and prostate cancers face significant challenges not
only in treating, but also diagnosing these diseases. Diagnostic tests are limited, and, in some cases, the tests’
ability to distinguish indolent vs. aggressive disease is questionable. New research on genetic tests and
biomarkers for disease, being presented during the 2011 Annual Meeting of the American Urological Association
(AUA), holds the promise for newer, better tests for these cancers. The studies will be presented to the press
during a special session on Monday, May 16, 2011 at 1:00 p.m. in the AUA Press Suite. The session will be
moderated by AUA Public Media Committee Chair Anthony Y. Smith, MD.
Studies being presented include:
Genetic Risk Variants On 8q24 Associated with Prostate Cancer Aggressiveness (#715): Certain genetic alleles
associated with prostate cancer risk may also be connected to aggressive pathology features and may predict
higher Gleason-grade disease in some men, according to researchers at Northwestern University. Genotypes for
certain previously reported risk alleles were determined for more than 900 men with Gleason 6 prostate cancers
who had undergone radical prostatectomy, and authors compared allele frequency for men whose tumors were
ultimately upgraded to a pathologic Gleason 7 and those whose final pathologic Gleason was 6. Those with risk
alleles on chromosomes 8q24 and 19q13 were 1.7 and 2.7 times more likely to be upgraded in the final
pathology tumor specimen, suggesting that certain genotypes may be a strong predictor of aggressive pathology
features.
Rational Basis for the Combination of PCA3 and TMPRSS2:ERG Gene Fusion in Prostate Cancer Diagnosis
(#1616): According to new data from Radboud University Nijmegen Medical Center in the Netherlands,
measuring TMPRSS2:ERG expression in addition to PCA3 may improve the sensitivity and accuracy of the PCA3
test for prostate cancer. Using tissue samples for benign prostatic hyperplasia (48 samples) and prostate cancer
(48 samples), as well as normal prostate tissue (32 samples), authors measured PCA3 and TMPRSS2:ERG
expression. The PCA3 test had a sensitivity of 84.4 for prostate cancer, but included one false-positive and seven
false-negative samples. The TMPRSS2:ERG gene fusion test was positive in 8.3 percent of the BPH samples, 15.6
percent of the normal tissue samples and half the prostate cancer samples. However, combining both tests

2. resulted in the highest sensitivity and diagnostic accuracy. Using TMPRSS2:ERG in addition to PCA3 added only
one false positive, and eliminated four of the seven false negatives seen with PCA3 alone.
Genetic Polymorphisms of CYP17A1 May Predict Early Progression after Primary Androgen Deprivation
Therapy in Japanese Men with Prostate Cancer (#2289): Certain genetic polymorphic variations may allow
physicians to predict a patient’s sensitivity to hormonal therapy to treat prostate cancer, according to new
researchers in Japan, who examined a possible correlation between certain single nucleotide polymorphisms
(SNPs) from eight genes involved in androgen synthesis and metabolism and a man’s progression to castration-
resistant disease. The period from diagnosis to data collection was 43 months. In this study, which included 214
patients, researchers compared the association of genotypes to the efficacy of androgen deprivation therapy,
and found that patients with SNP rs6162 on the CYP17A1 gene were more likely to experience cancer
progression following androgen deprivation therapy.
A TMPRSS2:ERG Gene Fusion Molecular Urine Assay Correlates with Pathologic Stage and Prostatectomy
Gleason Score and is Associated with Biopsy-to-Prostatectomy Gleason Upgrading (#2319): Researchers in
Germany and the United States will present data on a new quantitative TMPRSS2:ERG gene fusion urine assay to
predict outcomes in men with prostate cancer scheduled for radical prostatectomy. Researchers obtained urine
specimens from men to assess TMPRSS2:ERG levels prior to surgery, and compared these levels with post-
surgery pathologic findings. Of the 74 men, 28 had non-organ confined disease, and 69 had a Gleason score of 7
or greater. 21 patients with biopsy Gleason 6 disease were upgraded to a pathologic Gleason grade of 7 or
greater. Median TMPRSS2:ERG score was significantly higher in men with non-organ confined disease compared
to those who had organ-confined disease (80 vs. 9). Median TMPRSS2:ERG scores for patients with pathological
upgrading was 32, compared to 2 for those whose Gleason scores were not upgraded.
Autoantibody Signatures as Biomarkers to Distinguish Prostate Cancer from Benign Prostatic Hyperplasia
using a Native Antigen Capture Microarray Platform (#2325): A common criticism of the prostate-specific
antigen (PSA) test is its lack of specificity in differentiating between benign prostatic hyperplasia (BPH) and
prostate cancer. Through the use of a customized array platform, researchers at Brigham and Women’s Hospital
and Northeastern University have identified five autoantibody signatures to specific cancer targets that, when
the antigens were combined, were more effective than the PSA test in distinguishing between benign and
malignant disease.
Detection and Identification of a miRNA Expression Profile from Cell-Free Urine: Potential Utility in Bladder
Cancer (#1362): Micro ribonucleic acid (miRNA) molecules, previously shown to play a key role in tumorigenesis,
can play a promising role in diagnosing and treating cancers. Researchers from the Lahey Clinic in Boston
examined the role that miRNA might play in diagnosing bladder cancer. Using urine from patients with
confirmed bladder cancer and control patients with no history of cancer, authors isolated cell-free RNA from 35
healthy control patients and 142 patients with bladder cancer, and profiled 730 miRNAs. Disease progression
correlated with the number of miRNAs expressed, with healthy controls expressing 8 miRNAs and patients with
>T2 carcinoma expressing 228 miRNAs. Individual samples revealed an increase with some miRNA as disease
progressed, suggesting that miRNA profiling could be of future clinical value in the treatment of bladder cancer.

3. Pre-Operative Urinary Prostate Cancer Gene 3 (PCA3) is Predicting Pathologically Confirmed Small Volume
and Insignificant Prostate Cancer (#187): PCA3 has demonstrated success in identifying patients with prostate
cancer; however, new data from the Medical University of Graz in Austria suggests that the test may be a
valuable predictor of low-volume disease and may have a future role in managing patients on active surveillance
protocols. Using pre-operative PCA3 scores and tumor volume data from 160 patients, authors used logistic
regression models to identify endpoints for low-volume disease (less than 0.5 ml) and insignificant disease (using
Epstein criteria). Low tumor volume and pathologically insignificant prostate cancer were present in 21.2
percent (n=34) and 10 percent (n=16) of patients. In those patients with low-volume and/or insignificant
disease, PCA3 scores were significantly lower.
“The critical piece of the puzzle that is missing right now for treatment of a number of urologic cancers, but
particularly for prostate cancer, are biomarkers that can be used to tell us prior to treatment which patients
harbor slow growing indolent cancers, which harbor cancers that we might have a shot at curing and which
harbor cancers that are so aggressive that they require a systemic approach,” Dr. Smith said.
NOTE TO REPORTERS: Experts are available to discuss this study outside normal briefing times. To arrange an
interview with an expert, please contact the AUA Communications Office at the number above or e-mail
wisett@AUAnet.org.
About the American Urological Association: Founded in 1902 and headquartered near Baltimore, Maryland, the American
Urological Association is the pre-eminent professional organization for urologists, with more than 17,000 members
throughout the world. An educational nonprofit organization, the AUA pursues its mission of fostering the highest standards
of urologic care by carrying out a wide variety of programs for members and their patients.
###

4. 715
GENETIC RISK VARIANTS ON 8Q24 ASSOCIATED WITH PROSTATE CANCER AGGRESSIVENESS
Brian T. Helfand, Matthias D. Hofer, Qiaoyan Hu, Barry B. McGuire, Daniel C. O'Brien, William J. Catalona,
Chicago, IL
INTRODUCTION AND OBJECTIVES: Genome wide association studies have identified that a striking set of
prostate cancer (CaP) risk alleles are clustered within a large gene desert on chromosome 8q24. To date, more
than 8 different risk alleles have been mapped to this region. Our prior studies conducted in relatively small
populations of men have suggested that a few of these alleles are associated with aggressive pathology (e.g.
Helfand et al. J Urol, 2008;179: 2197). However, the collective influence of many of the 8q24 alleles on
aggressiveness in large populations remains to be determined.
METHODS: 1376 Caucasian men underwent radical prostatectomy from March 2003 to September 2009 at our
institution and were genotyped for 5 different risk alleles located on chromosome 8q24. The associations
between allele frequency, carrier status and adverse clinico-pathologic features were compared. Aggressive
disease was defined as pathologic Gleason score ?4+3 and/or pathologic tumor stage ?3b. Possible clinically
insignificant disease was defined using Ohori criteria: organ-confined, tumor volume <0.5cc, and no Gleason
grade 4 (Goto et al. J Urol, 1996; 156: 1059).
RESULTS: 3 of the 5 8q24 risk alleles were present at higher frequencies in men with aggressive disease (Table
1). There was a significantly higher proportion of carriers of the 8q24 risk allele, SNP rs16902094, with
aggressive disease compared to non-aggressive disease (44.2% vs. 28.4%, p <0.001). In addition, there was a
significantly lower proportion of carriers of this allele with ?insignificant? disease compared to ?significant?
disease (31.4% vs. 16.9%; p=0.01).
Location SNP Non-Aggressive (%) N=1123 Aggressive (%) N=253 P value
8q24 rs16901979 11.8 9.1 0.23
8q24 rs16902094 28.4 44.2 <0.001
8q24 rs445114 89.1 93.7 0.03
8q24 rs6983267 80.4 83.0 0.34
8q24 rs1447295 25.6 22.1 0.26
CONCLUSIONS: Risk alleles on chromosome 8q24 are associated with PCa susceptibility and aggressiveness.
Specifically, the rs16902094 allele significantly increase the risk of aggressive disease. Future confirmatory
studies in other populations are warranted.
Source of Funding: Supported in part by the Urological Research Foundation, Prostate SPORE grant (P50
CA90386-05S2) and the Robert H. Lurie Comprehensive Cancer Center Grant (P30 CA60553)

5. 1616
RATIONAL BASIS FOR THE COMBINATION OF PCA3 AND TMPRSS2:ERG GENE FUSION IN
PROSTATE CANCER DIAGNOSIS
Gregoire Robert, Sander Jannink, Tilly Aalders, Peter Mulders, Jack Schalken, Bordeaux, France
INTRODUCTION AND OBJECTIVES: The prostate cancer gene 3 (PCA3) and TMPRSS2:ERG gene
fusion are promising prostate cancer (PCa) specific biomarkers. Our aim was to simultaneously
quantify the expression levels of PCA3 and TMPRSS2:ERG in a large panel of benign prostatic
hyperplasia (BPH), normal prostate adjacent to PCa (NP) and PCa tissue samples, to provide a
rational basis for the understanding of the false-positive and false-negative results of the urine
assays.
METHODS: The tissue samples were carefully histopathologically characterized to obtain
homogeneous groups. The mRNA was isolated, transcribed into cDNA and the expressions of
PCA3 and TMPRSS2:ERG were measured using a quantitative real-time polymerase chain
reaction. The relative expression levels of the markers were normalized for the housekeeping
gene HPRT and were compared between the different groups.
RESULTS: We included 48 BPH, 32 NP and 48 PCa. The PCA3 test had a sensitivity of 85.4% but
led to the identification of 1 false-positive and 7 false-negative samples. The TMPRSS2:ERG gene
fusion test was positive in 8.3% of the BPH, 15.6% of the NP and 50% of the PCa samples. We
had to define a cut-off value to avoid 8 false-positive results with the TMPRSS2:ERG test. The
combination of the PCA3 test with the TMPRSS2:ERG test had the highest sensitivity and the
best diagnostic accuracy. In case of a negative PCA3 test, the addition of the TMPRSS2/ERG test
allowed to diagnose 4 of the 7 false-negative samples and added only 1 false-positive.
First Line Second Line Se (%) Sp (%) Youden Index
PCA3 - 85.4 98.7 0.84
TMPRSS2:ERG - 45.8 98.75 0.45
PCA3 + TMPRSS2:ERG - 91.7 97.5 0.89
PCA3 TMPRSS2:ERG 93.75 97.5 0.9
For PCA3, the cut-off value was 19.6; For TMPRSS2 :ERG, the cut-off value was 2.71
CONCLUSIONS: Most of the false-negative results of the PCA3 test were corrected by the
combination with TMPRSS2:ERG (57%). The combination had a higher sensitivity and a better
accuracy. Some of the control samples did express TMPRSS2:ERG and a cut-off value had to be
defined to avoid false-positive results.
Source of Funding: Grégoire Robert was granted by the EAU scholarship Program and by the
French Urological Association (AFU)

6. 2289
GENETIC POLYMORPHISMS OF CYP17A1 MAY PREDICT EARLY PROGRESSION AFTER PRIMARY
ANDROGEN DEPRIVATION THERAPY IN JAPANESE MEN WITH PROSTATE CANCER
Masashi Nakayama, Takeshi Yamada, Tomohito Shimizu, Shinpei Nonen, Kensaku Nishimura,
Kazuo Nishimura, Tsuneo Hara, Go Tanigawa, Toshiaki Yoshioka, Koji Hatano, Yasutomo Nakai,
Hitoshi Takayama, Yasushi Fujio, Junichi Azuma, Akihiko Okuyama, Norio Nonomura, Osaka-city,
Osaka, Japan
INTRODUCTION AND OBJECTIVES: The androgen deprivation therapy with LH-RH analogues
and/or anti-androgen is the standard therapy for advanced prostate cancer. However, there is a
large individual difference in the efficacy of the therapy. It is difficult to predict the duration of
response to the hormonal therapy. In this study, we have examined whether genetic
polymorphic variation can explain the sensitivity to hormonal therapy in Japanese patients.
METHODS: Two hundred fourteen patients with prostate cancer, primary treated with androgen
deprivation therapy, were enrolled into this study. The median observation period from
diagnosis to data collection was 43 months. We divided the subjects into three groups (I-III);
Group I, ninety five patients who progressed to CRPC earlier than 43 months (high risk patients):
Group II, eighty five patients who remained stable disease even after 43 months (low risk
patients): Group III, thirty four patients who exhibited stable disease condition with their
observation less than 43 months (short-period observation). We excluded the data of Group III
from the data set, and compared the association of genotypes with the efficacy to androgen
deprivation therapy in Groups I and II (high risk and low risk populations). We have selected 22
single nucleotide polymorphisms (SNPs) from 8 genes involved in androgen synthesis and
metabolism that are CYP17A1, HSD3B1, SRD5A1, SRD5A2, HSD17B3, CYP1B1, CYP 11A, and
CYP24A which is involved in metabolism of activated Vitamin D. The SNPs were assayed by
primer extension method. Logistic regression method, with adjustments for age, clinical disease
stage and Gleason score at diagnosis, was applied for the analysis.
RESULTS: The median observation period from diagnosis to data collection was 43 months. We
observed statistical significance for rs743572 A > G (p=0.01, OR (Odds-Ratio) 0.30, 95%CI 0.12-
0.79), rs6162 G >A (p=0.01, OR 3.33, 95% CI 1.27-8.72), rs6163 C > A (p=0.01, OR 3.33, 95% CI
1.27-8.72) and rs1004467 T > C (p=0.04, OR 2.43, 95%CI 1.03-5.73) in CYP17A1. There was no
significant difference in SNPs of other genes between two groups.
CONCLUSIONS: Although larger validation study is needed, our study suggests that genetic
polymorphisms in CYP17A1 are expected as good predictors for risk of progression in Japanese
prostate cancer patients receiving androgen deprivation therapy.
Source of Funding: none

7. 2319
A TMPRSS2:ERG GENE FUSION MOLECULAR URINE ASSAY CORRELATES WITH PATHOLOGIC STAGE AND
PROSTATECTOMY GLEASON SCORE AND IS ASSOCIATED WITH BIOPSY-TO-PROSTATECTOMY GLEASON
UPGRADING
Alexander Haese, Felix Chun, Sarah Meyer, Sheila Aubin, John Day, Jack Groskopf, Hamburg, Germany
INTRODUCTION AND OBJECTIVES: An unmet need in PCa prognosis is the differentiation between indolent and
significant PCa. Biochemical (e.g. PSA), clinical (e.g. clinical stage) or histological (BxGleason score) parameters,
alone or combined, are not sufficiently accurate to aid in this critical distinction. On a genetic basis, a fusion
between TMPRSS2 and the ETS family of transcription factors, found in 50-70% of PCa, is the most common
specific gene rearrangement identified to date among solid human malignancies. Studies have linked PCa gene
fusions to indicators of significant PCA. In this prospective, ongoing study, we evaluated the correlation of a
prototype quantitative TMPRSS2:ERG (T2:ERG) gene fusion urine assay with outcomes in men with PCa
scheduled for RRP
METHODS: Post-DRE first-catch urine specimens were collected prior to RRP. T2:ERG mRNA copies were
quantified using a transcription-mediated amplification assay and results normalized to PSA mRNA copies by
calculating the ratio of TMPRSS2:ERG/PSA copies x 100,000 (T2:ERG Score). The prototype T2:ERG urine assay
detects the gene fusion mRNA isoform corresponding to TMPRSS2 exon 1 to ERG exon 4. The T2:ERG Score was
correlated with the presence or absence of pathologically organ (OC) vs. non-organ-confined (NOC) PCa and the
presence or absence of Bx-to-RRP Gleason upgrading.
RESULTS: Of 74 subjects 28 (38%) had NOC-disease (?pT3) and 69 (93%) had a RRP Gleason score ?7. 21/26
subjects with BxGleason score of 6 were upgraded to Gleason Score ?7 at RRP. Median T2:ERG Score was
significantly higher in men with NOC vs. OC-PCa (80 vs. 9, p=0.002) and with RRP Gleason scores ?7 vs. 6 (31 vs.
2, p=0.04). The median T2:ERG Score for subjects with vs without Bx-to-RRP-upgrading was 32 vs 2, respectively.
CONCLUSIONS: The T2:ERG assay correlated significantly with pT-stage and RRPGleason score. Interestingly,
subjects with Bx-to-RRP-upgrading showed a trend towards higher median T2:ERG Scores. These data suggest
that a T2:ERG urine assay may be useful to decide when more aggressive treatment of PCa is necessary.
Source of Funding: none

8. 2325
AUTOANTIBODY SIGNATURES AS BIOMARKERS TO DISTINGUISH PROSTATE CANCER FROM BENIGN
PROSTATIC HYPERPLASIA USING A NATIVE ANTIGEN CAPTURE MICROARRAY PLATFORM
Dennis O'Rourke, Daniel DiJohnson, Michael O'Leary, Jerome Richie, Brian Liu, Boston, MA
INTRODUCTION AND OBJECTIVES: Serum prostate specific antigen (PSA) levels lack the specificity to
differentiate prostate cancer from benign prostate hyperplasia (BPH), resulting in unnecessary biopsies. We now
report the identification of 5 autoantibody signatures to specific cancer targets which may be capable of ruling
out a diagnosis of cancer for patients with non-malignant prostatic disease, such as BPH, in patients with
elevated serum PSA.
METHODS: To discover new biomarkers which may distinguish between prostate cancer and BPH, a native
antigen capture microarray platform was used. Briefly, well-characterized monoclonal antibodies were arrayed
onto nano-particle slides to capture native antigens from prostate cancer cells. Using the immobilized antigens
as baits, autoantibodies from prostate cancer patients and patients with BPH can be isolated and probed. From
preliminary experiments using an initial set of over 500 cancer related antigens, a customized array containing
27 unique antigens was further tested. Prostate cancer patient (n=41) and BPH patient serum samples with a
mean follow-up of 6.8 years without the diagnosis of cancer (n=39) were obtained. 100ug of IgGs were purified
and dye labeled with a Cy3 dye and incubated on the arrays. The arrays were scanned for fluorescence and the
intensity was quantified. For each spot, a signal-to-noise ratio (SNR) was measured to eliminate background
interference. Through comparative analysis of the prostate cancer arrays and the BPH arrays, autoantibody
signatures were identified. Receiver operating characteristic curves were produced and the area under the curve
(AUC) was determined for the 27 antigens.
RESULTS: Using the native antigen capture microarray platform, we found unique autoantibody signatures
capable of distinguishing between prostate cancer and BPH. A SNR was calculated for each autoantibody
reactivity on each array and compared. The top 5 autoantibody signatures were found to react with TARDBP,
TLN1, PARK7, PSIP1, and CALD1. Combining these antigens resulted in an AUC of 0.95 compared to 0.50 for PSA
when differentiating between prostate cancer and BPH in our cohort. In addition, the coefficient of variance
between duplicate runs for a given sample averaged 14.8% (range 11%-22%).
CONCLUSIONS: Our results demonstrate the ability of a native antigen capture microarray platform to identify
specific autoantibody signatures that can differentiate prostate cancer from BPH, and may result in the
reduction of unnecessary biopsies in patients with elevated PSA.
Source of Funding: NIH, DoD, and Inanovate, Inc.

9. 1362
DETECTION AND IDENTIFICATION OF A MIRNA EXPRESSION PROFILE FROM CELL-FREE URINE: POTENTIAL
UTILITY IN BLADDER CANCER
Jessica DeLong, Niall Harty, Spencer Kozinn, Ian Summerhayes, John Libertino, Kimberly Rieger-Christ, Brookline,
MA
INTRODUCTION AND OBJECTIVES: MicroRNAs are small, non-coding RNAs that have been shown to play an
important role in tumorigenesis. There is differential expression of miRNA in cancer progression, and profiling of
miRNA is promising for both diagnosis and treatment of malignant tumors. In this study we isolated RNA from
cell-free urine in an attempt to characterize miRNA profiles indicating the presence of urothelial carcinoma and
its potential use as a non-invasive assay to identify patients with cancer progression.
METHODS: Urine was collected from patients diagnosed with bladder cancer and control patients with no
history of cancer under an IRB-approved protocol. Specimens were then centrifuged and total RNA was isolated
from the supernatants using the mirVana Paris? kit. A total of 178 samples were grouped according to grade and
stage: healthy controls (35), TaG1 (19), T1G3 (16), ?T2 (30), carcinoma in situ (CIS; 28) and no evidence of
disease following therapy (50). Seven hundred and thirty miRNAs were profiled by qRT-PCR on pooled samples
within each group. Validation of selected miRNAs was performed on individual samples using qRT-PCR.
RESULTS: Cell-free RNA was isolated from urine of 35 healthy controls and 143 patients with bladder cancer. Of
the 730 miRNAs tested, 236 were detected in at least one of the pooled samples using a cycle threshold cutoff
of 35. The number of miRNAs detected in the pooled samples correlated with disease progression where the
healthy control group and the ?T2 group expressed 8 and 228 miRNAs, respectively. qRT-PCR of individual
samples revealed a gradual increase of some miRNAs with disease progression. Statistical analysis adjusted for
multiple comparisons demonstrated differences between groups based on miRNA expression levels. In addition,
a panel of miRNAs was identified which discriminated between cancer and cancer-free patients.
CONCLUSIONS: This study demonstrates the successful isolation of miRNAs from cell-free urine. Utilizing non-
invasive urine based assays, we identified a miRNA panel that can discriminate cancer-free patients and patients
with urinary carcinoma of the bladder. These findings provide evidence that profiling of miRNAs from cell-free
urine holds the promise for the development of valuable clinical tools.
Source of Funding: None.

10. 187
PRE-OPERATIVE URINARY PROSTATE CANCER GENE 3 (PCA3) IS PREDICTING PATHOLOGICALLY CONFIRMED
SMALL VOLUME AND INSIGNIFICANT PROSTATE CANCER
Marco Auprich, John F. Ward, Richard Babaian, Karl Pummer, Herbert Augustin, Ferdinand Luger, Stefan Gutschi,
Hartwig Huland, Alexander Haese, Graz, Austria
INTRODUCTION AND OBJECTIVES: Prostate CAncer Gene 3 (PCA3) score was recently identified to predict small
volume [tumor volume (TV) < 0.5ml] and pathologically insignificant prostate cancer (IPCa) prior to RP. Objective
was to evaluate PCA3?s potential to improve the multivariable accuracy in the prediction of pathological TV<
0.5ml and IPCa in a US-European cohort
METHODS: Complete retrospective clinical and pathological data of consecutive RP men form two two referral
centres including pre-operative PCA3 scores and computerized-assisted planimetrically measured tumor volume
data were available in 160 patients. PCA3 scores were assessed using the Progensa assay®. Beyond standard risk
factors (age, DRE, PSA, prostate volume, biopsy Gleason score, percent positive cores), five different PCA3
codings (continuously and cut-off 17, 24, 35, 47) were used in logistic regression models to identify five distinct
pathological endpoints: a) low volume disease (<0.5ml), b) insignificant PCa according to the Epstein criteria.
Accuracy estimates of each endpoint were quantified using the area under the curve (AUC) of the receiver
operator characteristic (ROC) analysis in models with and without PCA3.
RESULTS: Tumor volume <0.5 ml and pathological IPCa was present in 21.2% (n=34) and 10% (n=16) of patients
.PCA3 scores were significantly lower in low volume disease and insignificant PCa (p?0.001). AUC of
multivariable low volume disease (+2.4 to +5.5%) and insignificant PCa-models (+3 to +3.9%) increased when
PCA3 was added to standard clinical risk factors.
CONCLUSIONS: PCA3 was confirmed as valuable predictor of pathologically confirmed low volume disease and
insignificant PCa. Further exploration of its role as an additive marker to select patients for active surveillance
may be warranted
Source of Funding: none