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Evolving Intersection Between Inherited Cancer Genetics and Therapeutic Clinical Trials in Prostate Cancer: A White Paper From the Germline Genetics Working Group of the Prostate Cancer Clinical Trials Consortium.

Carlo MI, Giri VN, Paller CJ, Abida W, Alumkal JJ, Beer TM, Beltran H, George DJ, Heath EI, Higano CS, McKay RR, Morgans AK, Patnaik A, Ryan CJ, Schaeffer EM, Stadler WM, Taplin ME, Kauff ND, Vinson J, Antonarakis ES, Cheng HH.

JCO Precis Oncol. 2018;2018. doi: 10.1200/PO.18.00060. Epub 2018 Aug 16.


Alternative RNA Splicing as a Potential Major Source of Untapped Molecular Targets in Precision Oncology and Cancer Disparities.

Robinson TJ, Freedman JA, Al Abo M, Deveaux AE, LaCroix B, Patierno BM, George DJ, Patierno SR.

Clin Cancer Res. 2019 Feb 12. pii: clincanres.2445.2018. doi: 10.1158/1078-0432.CCR-18-2445. [Epub ahead of print]


Sources of Frustration Among Patients Diagnosed With Renal Cell Carcinoma.

Bergerot CD, Battle D, Bergerot PG, Dizman N, Jonasch E, Hammers HJ, George DJ, Bex A, Ljungberg B, Pal SK, Staehler MD.

Front Oncol. 2019 Jan 22;9:11. doi: 10.3389/fonc.2019.00011. eCollection 2019.


The promise of immunotherapy in genitourinary malignancies.

Zhang T, Armstrong AJ, George DJ, Huang J.

Precis Clin Med. 2018 Dec;1(3):97-101. doi: 10.1093/pcmedi/pby018. Epub 2018 Dec 19.


Next generation sequencing of PD-L1 for predicting response to immune checkpoint inhibitors.

Conroy JM, Pabla S, Nesline MK, Glenn ST, Papanicolau-Sengos A, Burgher B, Andreas J, Giamo V, Wang Y, Lenzo FL, Bshara W, Khalil M, Dy GK, Madden KG, Shirai K, Dragnev K, Tafe LJ, Zhu J, Labriola M, Marin D, McCall SJ, Clarke J, George DJ, Zhang T, Zibelman M, Ghatalia P, Araujo-Fernandez I, de la Cruz-Merino L, Singavi A, George B, MacKinnon AC, Thompson J, Singh R, Jacob R, Kasuganti D, Shah N, Day R, Galluzzi L, Gardner M, Morrison C.

J Immunother Cancer. 2019 Jan 24;7(1):18. doi: 10.1186/s40425-018-0489-5.


Overall Survival of Black and White Men With Metastatic Castration-Resistant Prostate Cancer Treated With Docetaxel.

Halabi S, Dutta S, Tangen CM, Rosenthal M, Petrylak DP, Thompson IM Jr, Chi KN, Araujo JC, Logothetis C, Quinn DI, Fizazi K, Morris MJ, Eisenberger MA, George DJ, De Bono JS, Higano CS, Tannock IF, Small EJ, Kelly WK.

J Clin Oncol. 2019 Feb 10;37(5):403-410. doi: 10.1200/JCO.18.01279. Epub 2018 Dec 21.


Adjuvant sunitinib in patients with high-risk renal cell carcinoma: safety, therapy management, and patient-reported outcomes in the S-TRAC trial.

Staehler M, Motzer RJ, George DJ, Pandha HS, Donskov F, Escudier B, Pantuck AJ, Patel A, DeAnnuntis L, Bhattacharyya H, Ramaswamy K, Zanotti G, Lin X, Lechuga M, Serfass L, Paty J, Ravaud A.

Ann Oncol. 2018 Oct 1;29(10):2098-2104. doi: 10.1093/annonc/mdy329.


Phase III Trial of Adjuvant Sunitinib in Patients with High-Risk Renal Cell Carcinoma: Exploratory Pharmacogenomic Analysis.

George DJ, Martini JF, Staehler M, Motzer RJ, Magheli A, Donskov F, Escudier B, Li S, Casey M, Valota O, Laguerre B, Pantuck AJ, Pandha HS, Patel A, Lechuga M, Ravaud A.

Clin Cancer Res. 2019 Feb 15;25(4):1165-1173. doi: 10.1158/1078-0432.CCR-18-1724. Epub 2018 Nov 6.


Precision Medicine Approaches When Prostate Cancer Akts Up.

Zhang T, George DJ, Armstrong AJ.

Clin Cancer Res. 2019 Feb 1;25(3):901-903. doi: 10.1158/1078-0432.CCR-18-2491. Epub 2018 Sep 11.


Information Transparency in the Drug Approval Process.

Rini BI, Burstein HJ, George DJ.

JAMA Oncol. 2018 Nov 1;4(11):1621-1622. doi: 10.1001/jamaoncol.2018.4143. No abstract available.


Leveraging γ-Glutamyl Transferase To Direct Cytotoxicity of Copper Dithiocarbamates against Prostate Cancer Cells.

Bakthavatsalam S, Sleeper ML, Dharani A, George DJ, Zhang T, Franz KJ.

Angew Chem Int Ed Engl. 2018 Sep 24;57(39):12780-12784. doi: 10.1002/anie.201807582. Epub 2018 Aug 29.


Comprehensive Genomic Profiling of Metastatic Tumors in a Phase 2 Biomarker Study of Everolimus in Advanced Renal Cell Carcinoma.

Gao X, Jegede O, Gray C, Catalano PJ, Novak J, Kwiatkowski DJ, McKay RR, George DJ, Choueiri TK, McDermott DF, Signoretti S, Bhatt RS.

Clin Genitourin Cancer. 2018 Oct;16(5):341-348. doi: 10.1016/j.clgc.2018.04.001. Epub 2018 Apr 25.


How we treat brain metastases in metastatic renal cell carcinoma.

Ramalingam S, George DJ, Harrison MR.

Clin Adv Hematol Oncol. 2018 Feb;16(2):110-114. Review. No abstract available.


Single-nucleotide polymorphisms of stemness genes predicted to regulate RNA splicing, microRNA and oncogenic signaling are associated with prostate cancer survival.

Freedman JA, Wang Y, Li X, Liu H, Moorman PG, George DJ, Lee NH, Hyslop T, Wei Q, Patierno SR.

Carcinogenesis. 2018 Jul 3;39(7):879-888. doi: 10.1093/carcin/bgy062.


Pazopanib in the Treatment of Bilateral Multifocal Renal Oncocytomas: A Case Report.

Labriola M, Foo WC, George DJ, Zhang T.

Clin Genitourin Cancer. 2018 Jun;16(3):e509-e512. doi: 10.1016/j.clgc.2018.02.017. Epub 2018 Feb 23. No abstract available.


Immune Checkpoint Blockade: The New Frontier in Cancer Treatment.

Clarke JM, George DJ, Lisi S, Salama AKS.

Target Oncol. 2018 Feb;13(1):1-20. doi: 10.1007/s11523-017-0549-7.


Clinical activity of nivolumab in patients with non-clear cell renal cell carcinoma.

Koshkin VS, Barata PC, Zhang T, George DJ, Atkins MB, Kelly WJ, Vogelzang NJ, Pal SK, Hsu J, Appleman LJ, Ornstein MC, Gilligan T, Grivas P, Garcia JA, Rini BI.

J Immunother Cancer. 2018 Jan 29;6(1):9. doi: 10.1186/s40425-018-0319-9.


Immune Biomarkers Predictive for Disease-Free Survival with Adjuvant Sunitinib in High-Risk Locoregional Renal Cell Carcinoma: From Randomized Phase III S-TRAC Study.

George DJ, Martini JF, Staehler M, Motzer RJ, Magheli A, Escudier B, Gerletti P, Li S, Casey M, Laguerre B, Pandha HS, Pantuck AJ, Patel A, Lechuga MJ, Ravaud A.

Clin Cancer Res. 2018 Apr 1;24(7):1554-1561. doi: 10.1158/1078-0432.CCR-17-2822. Epub 2018 Jan 26.


Biomarkers of immunotherapy in urothelial and renal cell carcinoma: PD-L1, tumor mutational burden, and beyond.

Zhu J, Armstrong AJ, Friedlander TW, Kim W, Pal SK, George DJ, Zhang T.

J Immunother Cancer. 2018 Jan 25;6(1):4. doi: 10.1186/s40425-018-0314-1. Review.


Increased Inflammation in Pericardial Fluid Persists 48 Hours After Cardiac Surgery.

Butts B, Goeddel LA, George DJ, Steele C, Davies JE, Wei CC, Varagic J, George JF, Ferrario CM, Melby SJ, Dell'Italia LJ.

Circulation. 2017 Dec 5;136(23):2284-2286. doi: 10.1161/CIRCULATIONAHA.117.029589. No abstract available.


Adjuvant Sunitinib for High-risk Renal Cell Carcinoma After Nephrectomy: Subgroup Analyses and Updated Overall Survival Results.

Motzer RJ, Ravaud A, Patard JJ, Pandha HS, George DJ, Patel A, Chang YH, Escudier B, Donskov F, Magheli A, Carteni G, Laguerre B, Tomczak P, Breza J, Gerletti P, Lechuga M, Lin X, Casey M, Serfass L, Pantuck AJ, Staehler M.

Eur Urol. 2018 Jan;73(1):62-68. doi: 10.1016/j.eururo.2017.09.008. Epub 2017 Sep 28.


Optimal use of radium-223 in patients with metastatic castration-resistant prostate cancer.

George DJ.

Clin Adv Hematol Oncol. 2017 Sep;15(9):690-694. No abstract available.


Acute Myeloid Leukemia After Olaparib Treatment in Metastatic Castration-Resistant Prostate Cancer.

Zhu J, Tucker M, Wang E, Grossman JS, Armstrong AJ, George DJ, Zhang T.

Clin Genitourin Cancer. 2017 Dec;15(6):e1137-e1141. doi: 10.1016/j.clgc.2017.07.005. Epub 2017 Jul 14. No abstract available.


Associations between RNA splicing regulatory variants of stemness-related genes and racial disparities in susceptibility to prostate cancer.

Wang Y, Freedman JA, Liu H, Moorman PG, Hyslop T, George DJ, Lee NH, Patierno SR, Wei Q.

Int J Cancer. 2017 Aug 15;141(4):731-743. doi: 10.1002/ijc.30787. Epub 2017 Jun 1.


Phase II trial of the PI3 kinase inhibitor buparlisib (BKM-120) with or without enzalutamide in men with metastatic castration resistant prostate cancer.

Armstrong AJ, Halabi S, Healy P, Alumkal JJ, Winters C, Kephart J, Bitting RL, Hobbs C, Soleau CF, Beer TM, Slottke R, Mundy K, Yu EY, George DJ.

Eur J Cancer. 2017 Aug;81:228-236. doi: 10.1016/j.ejca.2017.02.030. Epub 2017 May 11.


How Can We Effectively Address the Medical and Psychological Concerns of Survivors of Pelvic Malignancies?

Madden-Fuentes RJ, Koontz BF, Harrison MR, George DJ, Davidson B, Gilmore BF, Moul JW, Mantyh C, Peterson AC.

Oncology (Williston Park). 2017 Apr 15;31(4):286-94. Review.


Design and Rationale of the Metastatic Renal Cell Carcinoma (MaRCC) Registry: A Prospective Academic and Community-Based Study of Patients With Metastatic Renal Cell Cancer.

Bhavsar NA, Harrison MR, Hirsch BR, Creel P, Wolf SP, Samsa GP, Abernethy AP, Simantov R, Borham A, George DJ.

Cancer Invest. 2017 May 28;35(5):333-344. doi: 10.1080/07357907.2017.1289215. Epub 2017 Apr 3.


Phase I study of pazopanib plus TH-302 in advanced solid tumors.

Riedel RF, Meadows KL, Lee PH, Morse MA, Uronis HE, Blobe GC, George DJ, Crawford J, Niedzwiecki D, Rushing CN, Arrowood CC, Hurwitz HI.

Cancer Chemother Pharmacol. 2017 Mar;79(3):611-619. doi: 10.1007/s00280-017-3256-2. Epub 2017 Feb 25.


Cabozantinib Versus Sunitinib As Initial Targeted Therapy for Patients With Metastatic Renal Cell Carcinoma of Poor or Intermediate Risk: The Alliance A031203 CABOSUN Trial.

Choueiri TK, Halabi S, Sanford BL, Hahn O, Michaelson MD, Walsh MK, Feldman DR, Olencki T, Picus J, Small EJ, Dakhil S, George DJ, Morris MJ.

J Clin Oncol. 2017 Feb 20;35(6):591-597. doi: 10.1200/JCO.2016.70.7398. Epub 2016 Nov 14.


Prostate-specific antigen response in black and white patients treated with abiraterone acetate for metastatic castrate-resistant prostate cancer.

Ramalingam S, Humeniuk MS, Hu R, Rasmussen J, Healy P, Wu Y, Harrison MR, Armstrong AJ, George DJ, Zhang T.

Urol Oncol. 2017 Jun;35(6):418-424. doi: 10.1016/j.urolonc.2016.12.016. Epub 2017 Jan 23.


What is the role of sipuleucel-T in the treatment of patients with advanced prostate cancer? An update on the evidence.

Hu R, George DJ, Zhang T.

Ther Adv Urol. 2016 Aug;8(4):272-278. Epub 2016 May 2. Review.


Cabozantinib in genitourinary malignancies.

Zhang T, Park SE, Hong C, George DJ.

Future Oncol. 2017 Apr;13(8):755-765. doi: 10.2217/fon-2016-0358. Epub 2016 Nov 15. Review.


Recombinant oncolytic poliovirus, PVSRIPO, has potent cytotoxic and innate inflammatory effects, mediating therapy in human breast and prostate cancer xenograft models.

Holl EK, Brown MC, Boczkowski D, McNamara MA, George DJ, Bigner DD, Gromeier M, Nair SK.

Oncotarget. 2016 Nov 29;7(48):79828-79841. doi: 10.18632/oncotarget.12975.


Phase 1/2 multiple ascending dose trial of the prostate-specific membrane antigen-targeted antibody drug conjugate MLN2704 in metastatic castration-resistant prostate cancer.

Milowsky MI, Galsky MD, Morris MJ, Crona DJ, George DJ, Dreicer R, Tse K, Petruck J, Webb IJ, Bander NH, Nanus DM, Scher HI.

Urol Oncol. 2016 Dec;34(12):530.e15-530.e21. doi: 10.1016/j.urolonc.2016.07.005. Epub 2016 Oct 17.


Adjuvant Sunitinib in High-Risk Renal-Cell Carcinoma after Nephrectomy.

Ravaud A, Motzer RJ, Pandha HS, George DJ, Pantuck AJ, Patel A, Chang YH, Escudier B, Donskov F, Magheli A, Carteni G, Laguerre B, Tomczak P, Breza J, Gerletti P, Lechuga M, Lin X, Martini JF, Ramaswamy K, Casey M, Staehler M, Patard JJ; S-TRAC Investigators.

N Engl J Med. 2016 Dec 8;375(23):2246-2254. Epub 2016 Oct 9.


Novel immunotherapy approaches for metastatic urothelial and renal cell carcinoma.

Shao Z, Wang AZ, George DJ, Zhang T.

Asian J Urol. 2016 Oct;3(4):268-277. doi: 10.1016/j.ajur.2016.08.013. Epub 2016 Sep 6. Review.


Metastatic clear cell renal cell carcinoma: Circulating biomarkers to guide antiangiogenic and immune therapies.

Zhang T, Zhu J, George DJ, Nixon AB.

Urol Oncol. 2016 Nov;34(11):510-518. doi: 10.1016/j.urolonc.2016.06.020. Epub 2016 Aug 4. Review.


Can Radiologic Staging With Multiparametric MRI Enhance the Accuracy of the Partin Tables in Predicting Organ-Confined Prostate Cancer?

Gupta RT, Brown AF, Silverman RK, Tay KJ, Madden JF, George DJ, Polascik TJ.

AJR Am J Roentgenol. 2016 Jul;207(1):87-95. doi: 10.2214/AJR.15.15878. Epub 2016 Apr 11.


A rare case report of Solid Pseudopapillary Tumor of the pancreas with portal hypertension.

Reddy A, Sanniyasi S, George DJ, Narayanan CD.

Int J Surg Case Rep. 2016;22:35-8. doi: 10.1016/j.ijscr.2016.03.030. Epub 2016 Apr 3.


Development of a Novel c-MET-Based CTC Detection Platform.

Zhang T, Boominathan R, Foulk B, Rao C, Kemeny G, Strickler JH, Abbruzzese JL, Harrison MR, Hsu DS, Healy P, Li J, Pi C, Prendergast KM, Hobbs C, Gemberling S, George DJ, Hurwitz HI, Connelly M, Garcia-Blanco MA, Armstrong AJ.

Mol Cancer Res. 2016 Jun;14(6):539-47. doi: 10.1158/1541-7786.MCR-16-0011. Epub 2016 Mar 7.


Trial Design and Objectives for Castration-Resistant Prostate Cancer: Updated Recommendations From the Prostate Cancer Clinical Trials Working Group 3.

Scher HI, Morris MJ, Stadler WM, Higano C, Basch E, Fizazi K, Antonarakis ES, Beer TM, Carducci MA, Chi KN, Corn PG, de Bono JS, Dreicer R, George DJ, Heath EI, Hussain M, Kelly WK, Liu G, Logothetis C, Nanus D, Stein MN, Rathkopf DE, Slovin SF, Ryan CJ, Sartor O, Small EJ, Smith MR, Sternberg CN, Taplin ME, Wilding G, Nelson PS, Schwartz LH, Halabi S, Kantoff PW, Armstrong AJ; Prostate Cancer Clinical Trials Working Group 3.

J Clin Oncol. 2016 Apr 20;34(12):1402-18. doi: 10.1200/JCO.2015.64.2702. Epub 2016 Feb 22.


Patient experience in the treatment of metastatic castration-resistant prostate cancer: state of the science.

Nussbaum N, George DJ, Abernethy AP, Dolan CM, Oestreicher N, Flanders S, Dorff TB.

Prostate Cancer Prostatic Dis. 2016 Jun;19(2):111-21. doi: 10.1038/pcan.2015.42. Epub 2016 Feb 2. Review.


Everolimus versus sunitinib for patients with metastatic non-clear cell renal cell carcinoma (ASPEN): a multicentre, open-label, randomised phase 2 trial.

Armstrong AJ, Halabi S, Eisen T, Broderick S, Stadler WM, Jones RJ, Garcia JA, Vaishampayan UN, Picus J, Hawkins RE, Hainsworth JD, Kollmannsberger CK, Logan TF, Puzanov I, Pickering LM, Ryan CW, Protheroe A, Lusk CM, Oberg S, George DJ.

Lancet Oncol. 2016 Mar;17(3):378-88. doi: 10.1016/S1470-2045(15)00515-X. Epub 2016 Jan 13.


A phase 2 multimodality trial of docetaxel/prednisone with sunitinib followed by salvage radiation therapy in men with PSA recurrent prostate cancer after radical prostatectomy.

Armstrong AJ, Halabi S, Healy P, Lee WR, Koontz BF, Moul JW, Mundy K, Creel P, Wood S, Davis K, Carducci MA, Stein M, Hobbs C, Reimer B, Nguyen M, Anand M, Bratt L, Kim S, Tran PT, George DJ; Department of Defense Prostate Cancer Clinical Trials Consortium.

Prostate Cancer Prostatic Dis. 2016 Mar;19(1):100-6. doi: 10.1038/pcan.2015.59. Epub 2016 Jan 12.


Resource Use in the Last Year of Life Among Patients Who Died With Versus of Prostate Cancer.

Dinan MA, Li Y, Zhang Y, Stewart SB, Curtis LH, George DJ, Reed SD.

Clin Genitourin Cancer. 2016 Feb;14(1):28-37.e2. doi: 10.1016/j.clgc.2015.07.006. Epub 2015 Aug 6.


The future of kidney cancer treatment.

George DJ.

Clin Adv Hematol Oncol. 2015 Jun;13(6):368-71. No abstract available.


Clinical Trial Participants With Metastatic Renal Cell Carcinoma Differ From Patients Treated in Real-World Practice.

Mitchell AP, Harrison MR, Walker MS, George DJ, Abernethy AP, Hirsch BR.

J Oncol Pract. 2015 Nov;11(6):491-7. doi: 10.1200/JOP.2015.004929. Epub 2015 Sep 1.


Decreased Bioenergetic Health Index in monocytes isolated from the pericardial fluid and blood of post-operative cardiac surgery patients.

Kramer PA, Chacko BK, George DJ, Zhi D, Wei CC, Dell'Italia LJ, Melby SJ, George JF, Darley-Usmar VM.

Biosci Rep. 2015 Jul 1;35(4). pii: e00237. doi: 10.1042/BSR20150161.


A Single-Arm Phase 1b Study of Everolimus and Sunitinib in Patients With Advanced Renal Cell Carcinoma.

Kanesvaran R, Watt K, Turnbull JD, Armstrong AJ, Wolkowiez MC, George DJ.

Clin Genitourin Cancer. 2015 Aug;13(4):319-327. doi: 10.1016/j.clgc.2014.12.011. Epub 2014 Dec 30.


Development of a Standardized Set of Patient-centered Outcomes for Advanced Prostate Cancer: An International Effort for a Unified Approach.

Morgans AK, van Bommel AC, Stowell C, Abrahm JL, Basch E, Bekelman JE, Berry DL, Bossi A, Davis ID, de Reijke TM, Denis LJ, Evans SM, Fleshner NE, George DJ, Kiefert J, Lin DW, Matthew AG, McDermott R, Payne H, Roos IA, Schrag D, Steuber T, Tombal B, van Basten JP, van der Hoeven JJ, Penson DF; Advanced Prostate Cancer Working Group of the International Consortium for Health Outcomes Measurement.

Eur Urol. 2015 Nov;68(5):891-8. doi: 10.1016/j.eururo.2015.06.007. Epub 2015 Jun 28.

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