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. Author manuscript; available in PMC: 2017 Apr 1.
Published in final edited form as: Urol Oncol. 2014 Feb 2;34(4):182–192. doi: 10.1016/j.urolonc.2013.12.001

Table 4. Current clinical trials evaluating neoadjuvant targeted agents.

Identifier P.I. sponsor Target Neoadjuvant treatment outcome measures
NCT01695473 Febbo UCSF/Novartis PI3K BKM-120 Quantification of phospho-S6, phospho-AKT, phospho-4EBP1, and PSA response
NCT00526591 Garcia case Comprehensive Cancer Center mToR Everolimus Rates of pCR, extracapsular extension; margin status, toxicity, PSADT, and IHC for intraprostatic biomarkers
NCT00138918 Chi University of British Columbia/Department of Defense Clusterin oGX-011 Rate of pCR, quantify intraprostatic expression of clusterin, oGX-011; associate oGX-011 with PBMNC and serum clusterin
NCT00589472 Slovin NCI HDAC Vorinostat Rate of pCR, before and after levels of testosterone, DHT, DHEA, and DHEA-S in prostate tissue; gene and expression analysis of AR genes, PSA, and TMPRSS2
NCT01832259 Agarwal University of Utah VEGFR Pazopanib Decrease premetastatic niche (LN disease), PFS, and toxicity
NCT01409200 Zurita MD Anderson/Pfizer VEGFR Axitinib PFS
NCT01385059 Pal City of Hope VEGFR Axitinib Premetastatic niche density: quantitate VEGFR1 clusters, pSTAT3, MDSC, LoX, angiogenic factors, and bPFS
NCT00329043 Zurita MD Anderson/Pfizer VEGFR Sunitinib Rate of pCR
NCT00321646 Taplin lBIDMC, Duke, Genentech, Sanofi VEGF Bevacicumab + docetaxel Efficacy, safety
NCT00715104 Fong Dendreon/UCSF Dendritic cells Sip-T Intraprostatic T-cell infiltration
NCT00305669 Fong UCSF/NCI Immune GM-CSF Intraprostatic T-cell and dendritic cell infiltration
NCT01194271 Sharma MD Anderson Immune Ipilimumab + ADT Tumor and blood effector to regulatory T-cell ratio, CD4+ICoS+ T cells, CD8+ICoS+ T cells, NY-ESo-1 antibodies (only in blood), and absolute lymphocyte count (only in blood)
NCT00400517 Dreicer, Klein Cleveland Clinic Immune GM-CSF + Thalidomide Rates of pCR, negative surgical margins, PSA response, and PFS
NCT01696877 Antonarakis Sidney Kimmel Comprehensive Cancer Center Immune GVAX Intraprostatic CD8+ T-cell infiltration, intraprostatic CD4+ T-cell and Treg infiltration, quantification of tissue androgens and markers of apoptosis, serum antibodies to prostatic antigens, rate of pCR and PSA response, and PFS
NCT01804712 Howell Genentech CD-20 Rituximab Histologic response rate, change in: PSA, peripheral blood B cell count, and serum CXCL13 level