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PURPOSE To study the effectiveness of the Patient Preferences for Prostate Cancer Care (PreProCare) intervention in improving the primary outcome of satisfaction with care and secondary outcomes of satisfaction with decision, decision regret, and treatment choice among patients with localized prostate cancer. METHODS In this multicenter randomized controlled study, we randomly assigned patients with localized prostate cancer to the PreProCare intervention or usual care. Outcomes were satisfaction with care, satisfaction with decision, decision regret, and treatment choice. Assessments were performed at baseline and at 3, 6, 12, and 24 months, and were analyzed using repeated measures. We compared treatment choice across intervention groups by prostate cancer risk categories. RESULTS Between January 2014 and March 2015, 743 patients with localized prostate cancer were recruited and randomly assigned to receive PreProCare (n = 372) or usual care (n = 371). For the general satisfaction subscale, improvement at 24 months from baseline was significantly different between groups ( P < .001). For the intervention group, mean scores at 24 months improved by 0.44 (SE, 0.06; P < .001) from baseline. This improvement was 0.5 standard deviation, which was clinically significant. The proportion reporting satisfaction with decision and no regret increased over time and was higher for the intervention group, compared with the usual care group at 24 months ( P < .05). Among low-risk patients, a higher proportion of the intervention group was receiving active surveillance, compared with the usual care group ( P < .001). CONCLUSION Our patient-centered PreProCare intervention improved satisfaction with care, satisfaction with decision, reduced regrets, and aligned treatment choice with risk category. The majority of our participants had a high income, with implications for generalizability. Additional studies can evaluate the effectiveness of PreProCare as a mechanism for improving clinical and patient-reported outcomes in different settings.

348 Background: Several post-prostatectomy genomic tests are available; which are used to improve prognostication and to guide additional treatment after radical prostatectomy (RP). There has been no head to head comparison between these tests. The objective of this study is to compare the performance of two genomic tests in predicting oncological outcomes. Methods: 16 patients who underwent RP at the University of Pennsylvania (UPenn) (2013-2018), had adverse pathology (margin, and/or pT3a/b) and had each been tested with both Decipher (D) and Prolaris (P). Pearson correlation was used to compare scores from D and P as well as CCP scores and microarray derived CCP (mCCP). The associations of D and P with biochemical recurrence (BCR) and metastasis (M) was evaluated in survival analysis in a large cohort of RP patients treated at Johns Hopkins University (1992-2010) (JHU). Results: The median follow-up of the UPenn cohort was 24 months. 6 patients developed BCR and two distant M. There was a significant correlation between the D and P score (r=0.67,p=0.004), and between the 10-year BCR risk reported by P and the 5-year M risk reported by D (r=0.69, p=0.003). Each test called 7 patients to be high risk; 5 were in common. Both tests correctly called the 2 M cases as high risk and 4/6 BCR patients to be high risk. A microarray-derived CCP (mCCP) was highly correlated to the CCP scores reported from P (r=0.88, p=6.7e-6) in the UPenn cohort. To compare the prognostic performance of mCCP to D for predicting BCR and M, we used Post-RP cohort from JHU (N=355). Both scores were correlated (r=0.36, p2e-12). D and mCCP were stratified into 5 groups of incremental 20%. When including mCCP groups, D groups, Gleason score, SVI, EPE, LNI, and PSA; D remained independent prognostic variable of BCR (HR 1.16, 95%CI [1.05-1.3], p=0.005) and M (HR 1.3, 95%CI [1.12-1.52], p=0.0005). However, mCCP was not prognostic of BCR (p=0.59) nor M (p=0.62). Conclusions: The findings from this study show that P and D scores post-RP were highly correlated and help in identifying patients who at high risk of progression in this small cohort with short follow up. However, D outperformed mCCP for predicting BCR and M in larger cohorts with longer follow up.

Purpose To determine the recommended phase II dose (RPTD) of the farnesyltransferase (FTase) inhibitor tipifarnib when combined with doxorubicin and cyclophosphamide (AC) in patients with advanced breast cancer, the pathologic complete response (pCR) rate after preoperative treatment with four cycles of the combination in locally advanced breast cancer (LABC), and the effect of tipifarnib on primary tumor FTase enzyme activity in vivo. Patients and Methods Thirty-two patients with metastatic breast cancer (n = 11) or LABC (n = 21) received AC (doxorubicin 60 mg/m2 and cyclophosphamide 600 mg/m2) administered intravenously on day 1 plus tipifarnib (100, 200, or 300 mg bid for 6 to 14 days) without (n = 2) or with (n = 30) granulocyte colony-stimulating factor (G-CSF) for up to four cycles. Patients with LABC underwent surgery after up to four cycles of the combination. Results When combined with AC every 2 weeks plus G-CSF, the RPTD of tipifarnib was 200 mg bid administered on days 2 to 7. Seven (33%) of 21 patients (95% CI, 15% to 55%) with LABC treated with up to four cycles of the combination at the RPTD had a pCR in the breast at surgery. The five patients had serial biopsies that demonstrated at least 50% FTase enzyme inhibition in the primary tumor (median, 100%; range, 55% to 100%) after tipifarnib. Conclusion Tipifarnib may be safely combined with dose-dense AC using a dose and schedule that significantly inhibits FTase enzyme activity in human breast cancer in vivo and may enhance the pCR rate after four cycles of preoperative dose-dense AC.

e576 Background: To determine the five year survival impact of primary surgery compared to radiation therapy in older men with high risk prostate cancer. Methods: This was a population-based cohort study using Surveillance, Epidemiology, and End Results (SEER)-Medicare patients 66 years or older, diagnosed for prostate cancer between 2004 and 2008. High-risk prostate cancer was identified as Gleason score of ≥ 8, or clinical stage T3a. Treatments studied were definitive local (curative intent) therapy (surgery or radiation therapy) within 180 days of prostate cancer diagnosis. The two treatment groups were retrospectively followed for one-year pre and five years post diagnosis. Main outcome measure was five-year all-cause mortality and cancer specific mortality. Sequential Cox regression was used to assess the hazard of mortality associated with surgery, compared to radiation therapy, after adjusting for socio-demographic variables, variables and propensity score. Results: We identified a cohort of 24,838 men newly diagnosed for high-risk for prostate cancer between 2004 and 2008. Forty-seven percent of these had surgery (n = 11,696) as well as radiation therapy (n = 11,724) as a primary treatment with curative intent within 180 days of diagnosis. Mean age at diagnosis of radiation therapy group was higher compared to surgery group (73.5, sd = 5.3 vs. 70.3, sd = 4.9; p = 0.020). Radiation group had higher comorbidity compared to surgery group (37% vs. 26%, p = 0.0316). Unadjusted all-cause mortality comparison over five years of follow-up showed that surgery treatment was associated with lower mortality (HR = 0.58, CI = 0.54, 0.62). After adjusting for propensity score, the hazard of all-cause five year mortality remained lower for surgery compared to radiation therapy (HR = 0.86, CI = 0.78, 9.4). Conclusions: Over a five-year follow-up, primary surgery was associated with improved survival compared to radiation therapy in high-risk prostate cancer patients. Longer follow-up is needed to determine if the survival advantage of surgery will persist as well as factors contributing to the difference in survival.

102 Background: The surgical learning curve for robotic assisted laparoscopic radical prostatectomy (RALP) is often cited as being shorter than for other surgical modalities. However, while this appears true with regards to surgical safety, the learning curve for more refined variables like positive surgical margin (PSM) rate and operative time (OT) is not well established. Our objective was to assess the surgical learning curve for RALP in terms of these parameters. Methods: We performed a retrospective cohort study of 3,794 patients who underwent RALP between Jan 2003 and Sep 2009 by three surgeons (DL, PW, AKT) from three centers (UPenn, Karolinska, Cornell). Mean overall PSM rates and mean overall OT were calculated for all three surgeons at intervals of 50 RALPs per surgeon, and learning curves for these means were fit using a loess method. R version 2.71 was used for all statistical analysis. Results: The learning curve for PSM rates for all patients demonstrated improvements that continued with greater surgeon experience, with over 1,600 cases required to get a PSM rate Conclusions: The learning curve for RALP is not as short as previously thought, and a large number of cases are needed to get PSM rates and OTs to a minimum. This suggests that RALP should be performed by high volume surgeons in order to optimize patient outcomes. [Table: see text]