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Purpose: Black men are more likely to die as a result of prostate cancer than white men, despite effective treatments that improve survival for clinically significant prostate cancer. We undertook this study to identify gaps in prostate cancer care quality, racial disparities in care, and underlying reasons for poorer quality care. Methods: We identified all black men and random age-matched white men with Gleason scores ≥ 7 diagnosed between 2006 and 2013 at two urban hospitals to determine rates of treatment underuse. Underuse was defined as not receiving primary surgery, cryotherapy, or radiotherapy. We then interviewed treating physicians about the reasons for underuse. Results: Of 359 black and 282 white men, only 25 (4%) experienced treatment underuse, and 23 (92%) of these were black. Most (78%) cases of underuse were due to system failures, where treatment was recommended but not received; 38% of these men continued receiving care at the hospitals. All men with treatment underuse due to system failures were black. Conclusion: Treatment rates of prostate cancer are high. Yet, racial disparities in rates and causes of underuse remain. Only black men experienced system failures, a type of underuse amenable to health information technology–based solutions. Institutions are missing opportunities to use their health information technology capabilities to reduce disparities in cancer care.

30 Background: A major clinical challenge is to identify patients at increased risk of high-grade prostate cancer (PCa) (Gleason scores ≥ 7) before biopsy. Thus, we evaluated the clinical utility of SelectMDx and Prostate Health Index (phi) tests for diagnosis of high-grade PCa as compared with transperineal mapping biopsy (TMB) results, where an average of 80 prostate needle biopsies are taken every 5 mm for a diagnostic accuracy of 98%. Methods: 70 patients were selected who had TMB. They were evaluated with both SelectMDx and phi tests from before or after TMB; all had serum and post-digital rectal examination urine samples collected prior to treatment, stored in our biorepository. phi was evaluated using proPSA, free PSA and total PSA in serum. SelectMDx test measured mRNA levels of the HOXC6 and DLX1 in post-DRE urine. Published data shows that phi

e17032Background: Recent trials showed improved overall survival (OS) with upfront use of docetaxel in addition to androgen deprivation therapy (ADT) in patients with hormone-sensitive prostate can...

e18753Background: The most common cancer in American men is adenocarcinoma of the prostate. With an enormous prognostic heterogeneity, identifying prognostic markers in this patient population beco...

e548 Background: Currently, active surveillance is an appropriate option for patients who have low risk PCa as determined by the NCCN as Gleason Score (GS) ≤ 6 and a PSA 0.05). Next we reviewed the presence of tertiary pattern 5 within these 3+4 patients and found it present in 1 patient who was AA. For the 19 patients with ≥ 4+3 upgrading, with respect to race (7 AA, 12 non-AA, p = .08) there were no significant differences in age, serum PSA, median positive and total cores taken at biopsy. However, when comparing these 19 upgraded ≥ 4+3 patients to the total cohort, they had a higher median serum PSA (6.16 ng/dLvs 5.4 ng/dL) and higher positive cores (4 vs 3) on biopsy. For these 19 patients, upgrading resulted in reclassification from low to high-grade (GS ≥ 8) PCa in 7 patients. Conclusions: African American patients with low risk PCa have do not have an increased risk of significant upgrading at RP when compared with other races, and further investigation is needed to identify factors that contribute to upgrading.

20 Background: Stereotactic body radiation therapy (SBRT) takes advantage of the prostate’s low α/β ratio to deliver a large radiation dose in a few fractions. This prospective study expands upon prior studies to further evaluate SBRT efficacy and QOL for a large patient population that includes low-, intermediate- and high-risk patients with prostate cancer. Methods: 515 patients with organ-confined prostate cancer (471 T1c and 44 T2a, all N0M0) received robotic SBRT. The median age was 69 years and the median PSA was 6.48 ng/ml. By NCCN criteria, 324 patients were low-risk, 139 were intermediate-risk, and 52 were high-risk. Androgen deprivation therapy was administered to 70 patients for up to one year. 158 patients with Gleason scores < 4+3 received 35 Gy delivered in 5 daily fractions. The remaining patients, from all risk groups, received a total dose of 36.25 Gy in 5 daily fractions. The proximal seminal vesicles were treated except in low-risk cases. Biochemical failure was assessed using the Phoenix criterion and QOL was assessed with EPIC scoring. Results: At a median follow-up of 84 months, 74 patients died (72 from unrelated causes). The median PSA at 78 months was 0.11 ng/ml. The actuarial 9 year freedom from biochemical failure was 95%, 89%, and 66% for the low-, intermediate- and high-risk groups (p = 0.01). For patients with Gleason scores < 4+3, there was no difference in terms of median nadir or biochemical control between doses of 35 and 36.25 Gy. Late RTOG toxicity was mild with 4% grade 2 rectal, 9.5% grade 2 urinary, and 1.9% grade 3 urinary. Late grade 2-3 urinary toxicity was 6.9% for 35 Gy vs. 13.2% for 36.25 Gy (p = 0.01). Mean EPIC urinary and bowel QOL declined at 1 month post-treatment and returned to baseline by 2 years where it remains. EPIC sexual QOL declined by 29% at 78 months. Conclusions: SBRT alone produces excellent biochemical control rates at up to 9 years with mild toxicity and minimal impact on quality of life. These long-term results appear superior to standard IMRT with lower cost and are strikingly similar to HDR therapy. These results also strongly suggest that 35 Gy is as effective as 36.25 Gy for patients with Gleason < 4+3, with less urinary toxicity.

88 Background: Appropriate risk stratification of men on active surveillance for prostate cancer is essential to identify men in whom it is safe to take this deferred treatment approach. This study evaluates upstaging rates using MRI-US fusion targeted biopsy in men who have had a prior positive standard 12-core biopsy. Methods: Between 12/2012 and 06/2015, 374 men with an indication for prostate biopsy underwent pre-biopsy mpMRI followed by 12-core standard trans-rectal mapping biopsy (Mbx) and MRI-Ultrasound fusion targeted biopsy (Tbx) of lesions identified on mpMRI. The combination of Mbx and Tbx, when both occurred, constitutes a fusion biopsy (Fbx). Men who underwent both Mbx with or without Tbx using the Artemis/Pro-Fuse system with a previous non-MRI-guided biopsy and a diagnosis of prior Gleason 6 prostate cancer were included. Patients without a lesion on MRI underwent Mbx only. Maximum Gleason scores (GS) were assigned on a per patient basis with Mbx GS available for all patients in the cohort and Tbx GS available only for patients with a lesion visible on MP-MRI. Clinically significant (CS) cancer was defined as GS ≥ 3+4. GS per patient was compared by chi-square and McNemar’s test. Results: 118 patients met inclusion criteria (Mean PSA = 6.9, Mean age = 62.5). 40 patients (34%) were upstaged by Fbx to Gleason ≥ 7. Of those upstaged, 17 men (14%) would have been missed by Mbx alone, in comparison to 7 (6%) that were missed by Tbx alone. Total number of prior biopsies (p = 0.28) and number of years on Active Surveillance (p = 0.22) were not related to upgrade on Fbx. Older men (65.3 vs. 60.9, p = 0.033) and those with higher PSA (8.7 vs 5.8, p = 0.002) were more likely to be upgraded on Fbx. Tbx was more likely to identify CS cancer than Mbx (85% vs 56%; p < 0.012). Conclusions: MP-MRI Fusion biopsy more accurately stratifies men with a previous prostate biopsy than those receiving a template mapping 12-core biopsy alone. Tbx should be strongly considered before enrolling a patient in active surveillance since up 14% of clinically significant cancer would have been missed with a 12-core biopsy alone. [Table: see text]

90 Background: Patients with an elevated PSA but negative prostate biopsy present a diagnostic and management dilemma. We evaluated the capability of multi-parametric (MP) MRI and MRI-USG Fusion prostate biopsy to detect clinically significant (CS) prostate cancer in men who have had a prior negative 12-core standard biopsy. Methods: Between 12/2012 and 06/2015, 374 men with an indication for prostate biopsy underwent pre-biopsy mpMRI followed by 12-core standard trans-rectal mapping biopsy (Mbx) and MRI-Ultrasound fusion targeted biopsy (Tbx) of lesions identified on mpMRI. The combination of Mbx and Tbx, when both occurred, constitutes a fusion biopsy (Fbx). Men who underwent both Mbx with or without Tbx using the Artemis/Pro-Fuse system with a previous biopsy but no diagnosis of prostate cancer were included. Patients without a lesion on MRI underwent Mbx only. Maximum Gleason scores (GS) was assigned on a per patient basis with Mbx GS available for all patients in the cohort and Tbx GS available only for patients with a lesion visible on MP-MRI. CS cancer was defined as GS ≥ 3+4. GS per patient was compared by chi-square and McNemar’s test. Results: 138 men (mean age = 64.0, mean psa = 11.6) met inclusion criteria. Fbx cancer detection rate in this population was 42%. 17 men (12%) were missed by Mbx but picked up on Tbx. Of these 17 men, 13 had Gleason ≥ 7.In comparison, 15 men were missed by Tbx, but only 2 were Gleason ≥ 7. Tbx had a higher rate of detection of CS cancer than Mbx, but this did not reach statistical significance (86% vs 68%, p = 0.09). MRI suspicion level correlated with the detection of CS cancer (p = 0.012). None of the 20 men with a negative MRI had GS ≥ 7 cancer detected on Mbx. The number of prior negative biopsies was not related to the likelihood of finding CS cancer on Fbx (p = 0.47). Conclusions: MRI suspicion score predicts detection of CS prostate cancer when paired with MRI-USG Fbx of the prostate, with a negative MRI correlating with no evidence of CS cancer on biopsy. MRI is a biomarker in this population that may, with more corroborative data, allow for men with a negative MRI to avoid repeat biopsies. [Table: see text]

150 Background: Results from 12-core template mapping biopsy (Mbx) and concurrent MRI-US fusion targeted biopsy (Tbx) were compared in 118 men without prior biopsy. Methods: Between 12/2012 and 06/2015, 374 men with an indication for prostate biopsy presented to our institution and underwent pre-biopsy mpMRI followed by 12-core standard trans-rectal mapping biopsy (Mbx) and MRI-Ultrasound fusion targeted biopsy (Tbx) of lesions identified on mpMRI. The combination of Mbx and Tbx, when both occurred, constitutes a fusion biopsy (Fbx). Men who underwent both Mbx with or without Tbx using the Artemis/Pro-Fuse system with no previous biopsy were included. Patients without a lesion on MRI underwent Mbx only. Maximum Gleason scores (GS) was assigned on a per patient basis with Mbx GS available for all patients in the cohort and Tbx GS available only for patients with a lesion visible on MP-MRI. Clinically significant (CS) was defined as GS ≥3+4. GS per patient was compared by chi-square and McNemar’s test. Results: 118 men met inclusion criteria (mean age=64.9, mean PSA=11.5). Prostate cancer was detected in 64 (54%) Fbx cases. Cancer detection rates for Mbx and Tbx were 54% and 57%, respectively. In patients where Fbx identified CS cancer, Tbx was more likely to have identified the cancer than Mbx (96% vs 72%; p < 0.001). Fewer GS 6 cancers were detected by Tbx (n=7) than by Mbx (n=25), and Tbx alone would have prevented the detection of 21 (18%) cases of GS 6 disease. Conversely, more GS≥ 7 (50% of men) was detected on Tbx than on Mbx (33% of men). In total, there were 16 patients (13.5%) that were missed or understaged by Tbx, but only 4 of these patients (3%) were GS≥ 7. In contrast, there were 19 (16%) patients that were missed or understaged by Mbx, but 17 (14%) of these 19 patients harbored GS≥ 7 disease. Conclusions: In biopsy-naive men who are suspected to have prostate cancer, Tbx provides improved detection of CS prostate cancer compared with Mbx while decreasing the detection of low-grade disease. Tbx alone in biopsy-naive men should be considered if missing 3% of CS disease is acceptable. [Table: see text]

56 Background: As the use of multiparametric MRI (mpMRI) to diagnose prostate cancer (PCa) becomes established, better knowledge of treatment patterns is needed to counsel patients. Prior studies have shown 40-55% undergo Radical Prostatectomy (RP), while only 6% prefer Active Surveillance (AS), and that stratification by risk does not greatly alter treatment pathways. We aim to delineate the distribution of PCa treatment modalities in the MRI/US fusion-guided prostate biopsy (FB) era. Methods: A retrospective review was performed of all patients who underwent FB at the NIH from 2010 to present. Demographics, Gleason scores, MRI Suspicion scores and treatment outcomes were recorded. Patients were stratified according to D’Amico Risk Criteria, and outcomes were coded into four categories: AS; RP; Radiation (XRT, Brachytherapy); and Other (Systemic or Focal therapy). Results: 839 men were reviewed. Mean age was 62.6 years old and mean PSA was 9.7 ng/mL. Total cancer detection rate was 70% (n = 589). Of FB positive men, 474 had treatment information available. Overall 225 (47.5%) entered AS, 158 (33.3%) underwent RP, 61 (12.9%) received XRT, and 30 (6.3%) received other intervention. Subgroup analysis by MRI suspicion score (Table) showed 47.4% frequency of RP in the high vs. 30.9% and 19.4% for moderate and low suspicion groups, respectively. Analysis by D’Amico Risk (Table) showed 86% of low risk men chose AS vs. 0% of high risk men. Conversely 9.7% of low, 44.5% of intermediate and 55.7% of high risk men underwent RP. Conclusions: FB was associated with a higher rate of AS choice as a treatment modality for low risk disease. However most patients with clinically significant PCa still chose RP as their treatment. FB is an additional tool that allows the urologist to better counsel patients and provides individualized treatment for PCa. [Table: see text]

118 Background: Stereotactic Body Radiation Therapy (SBRT) is a standard therapeutic option for men with prostate adenocarcinoma. There is a small body of literature characterizing a PSA bump after treatment with SBRT. Despite this, there is a paucity of data addressing rates of transient PSA increase immediately after SBRT treatment and what factors portend for this rare occurrence. This study reports outcomes on initial PSA after SBRT therapy for men who have received definitive SBRT for prostate cancer. Methods: Between May 2006 and February 2014, 921 patients with prostate cancer were treated with SBRT delivered via Cyberknife therapy. The mean age was 67 years old. 68.5% of patients were Caucasian, 17.4% African American, and 14.1% were another ethnicity. Patients were divided into prognostic risk groups with 44.7%, 43.5%, and 11.1% of patients falling in the low, intermediate, and high risk stratifications. Gleason scores were < 6 in 44.4%, 7 in 41.3%, and 8-10 in 14.2%. 37 patients also received supplemental external beam radiation (median dose 4500cGy) and 8.9% of patients received Androgen Deprivation Therapy (ADT) as part of their treatment regimen. Pre-treatment PSA was 0.8 – 205 ng/ml (median 6.1). Results: At 3 months’ follow-up, 2.8% of patients had a PSA elevated above their baseline value. 27.8% of patients age ≤50 (p

e17678 Background: Black men are more likely to develop and die of prostate cancer than white men. Past studies show lower rates of definitive treatment among black men. However these studies included early-stage disease for which treatments may not be beneficial. We undertook this study to assess the quality of prostate cancer treatment among men with intermediate & high risk prostate cancer who could benefit from active therapies. Methods: A Steering Committee of experts in prostate cancer care reviewed the evidence to create quality measures of proven effective treatments of intermediate & high risk prostate cancer. All black and a random sample of white men with Gleason Scores of >7, diagnosed at an inner-city academic center between 2007 and 2012, were identified from pathology and charts abstracted for clinical, pathologic and treatment data. Results: Of 289 black & 266 white men identified, average age was 60y (SD=8.5) with no racial difference in age or insurance coverage. 14% of men had D’Amico i...

279 Background: We examined biochemical outcome of small volume prostate cancers (

214 Background: Jamaican men appear to have higher age adjusted incidence rates (302/100K) than African Americans (250/100K) and Caucasians (182/100K). The purpose of this study is to examine the clinicopathologic findings in Jamaican born men presenting to Memorial Sloan-Kettering Cancer Center over a five-year period. Methods: We reviewed the records of 150 Jamaican-born men seen at MSKCC for prostate cancer between 2003 and 2008. Age at diagnosis, highest pretreatment PSA levels, Gleason scores, and clinical stage were tabulated. Pathologic T and N stage was included for patients undergoing prostatectomy. Results: 23 patients were excluded because the diagnosis of prostate cancer was not confirmed. The mean age at diagnosis was 59 years (37-77). The median PSA was 8 ng/mL (1-7,400 ng/mL). The distribution of Gleason scores was Gleason 6: 51 patients (40%), Gleason 7: 57 patients (45%), and Gleason 8-10: 19 patients (15%). 92% (75/81) of the men had organ confined disease by (cT1-2) by DRE. Of 46 men who had prostatectomy, 31 (67%) had organ confined disease (p T2) and 84% (37/44) were node negative. Conclusions: Without a comparison cohort, no firm conclusions can be drawn. But, Jamaican born men presenting to MSKCC for treatment of prostate cancer do not seem to have unusually adverse pretreatment characteristics or more advanced pathological findings at prostatectomy. Our results may be affected by referral bias in favor of patients with lower risk disease. Further research is needed to determine if Jamaican men with prostate cancer present with more advanced stage or higher grade disease than men in the general population. No significant financial relationships to disclose.

5117 Background: HIFU is an emerging ablative modality for the treatment of localized prostate cancer with limited reports on oncological outcome. We prospectively analyzed our 2-year results. Methods: 253 consecutive patients (age: 64+8) were treated with a planed single session of HIFU using the Ablatherm integrated imaging model system between January 2006 and June 2008. Patients were followed (median: 12; range 3–24 months) with PSA measurement every 3 months. Patients who received prior radiation or hormonal therapy (n=25) and patient for whom at least 2 consecutive PSA measurements were not available (n = 32) were excluded, leaving a total of 196 patients for analysis. Mean pre-treatment PSA was 6.9+3.3. Biopsy Gleason scores at diagnosis (median 9 cores) were 5, 6, 3+4, 4+3 in 1, 91, 66 and 38 patients, respectively. Biochemical failure (BCF) is reported using the Stephenson (PSA >0.4ng/ml and rising), Horwitz (2 consecutive increases of at least 0.5ng/ml) and Phoenix (nadir+2ng/ml) definitions. Results: 196 patients (age: 64+8) met the inclusion criteria for analysis. 75 had low and 121 had intermediate D'Amico's risk stratification disease. Mean and median absolute PSA nadir levels were 0.28+0.53 and 0.06 ng/ml respectively. It was achieved in median time of 3 months and remained unchanged in 70% of the patients throughout the follow-up. Overall 2 years BCF free rates were 70 % (62–78%), 86 % (81–91%) and 96% (91–99%) according to the Stephenson, Horwitz and Phoenix definitions, respectively; with no significant differences between risk groups. Predictors of BCF were absolute nadir [HR: 3.0 (2.3–3.8)] and pre-treatment PSA [HR: 1.1 (1.0–1.2)]. Conclusions: This is the only study to date that analyzed post HIFU BCF free rates according to post radical prostatectomy definition of BCF. BCF usually occur in the first year and plateau thereafter. Short term results by all BCF definitions are promising with similar results for patients with low and intermediate risk. Pre-HIFU PSA and post-HIFU PSA nadir levels are predictors for BCF. [Table: see text]