Methods and kits for diagnosis of cancer and prediction of therapeutic value

Abstract

A method for identifying a patient for cancer therapy can include administering a diagnostic dose of a detectably labeled first binding agent to a patient, the detectably labeled binding agent being capable of binding a molecular target. The method also includes selecting a patient for administration of a therapeutic dose of a second binding agent capable of binding a cellular target, wherein the selected patient exhibits a positive reading for the detectably labeled first binding agent. Furthermore, the method can include administering a therapeutic dose of the second binding agent to the patient.

1 . A method for identifying a patient for cancer therapy comprising:
 providing a first binding agent capable of binding a first molecular target, wherein the first molecular target is selected from a pathway related to cancer;   assessing the presence of the first binding agent in a tissue, cells or bodily fluid in a patient;   selecting a patient for administration of a therapeutic dose of a second binding agent capable of binding a second molecular target, wherein the patient is selected if the first binding agent is present.   
     
     
         2 . The method of  claim 1  wherein the first binding agent comprises a detectable label. 
     
     
         3 . The method of  claim 1  wherein the step of assessing further comprises administering the patient with a diagnostic dose of a detectably labeled first binding agent, the detectably labeled binding agent being capable of binding the first molecular target; and
 in vivo imaging the detectably labeled first binding agent in the patient. 
 
     
     
         4 - 7 . (canceled) 
     
     
         8 . The method of  claim 1  wherein the cancer is a prostate cancer and wherein the first binding agent is capable of binding to an extracellular domain of Prostate Specific Membrane Antigen (PSMA). 
     
     
         9 . The method of  claim 1  wherein the first binding agent is capable of binding to an extracellular domain of Prostate Specific Membrane Antigen (PSMA) in the neo-vasculature of a solid tumor. 
     
     
         10 . The method of  claim 2 , wherein the detectably labeled agent comprises a Positron Emission Tomography (PET) agent. 
     
     
         11 . The method of  claim 1  wherein the first or second binding agent comprises a radiolabel. 
     
     
         12 . The method of  claim 11  wherein the radiolabel is at least one of  177 Lu,  111 Indium,  67 Cu,  18 F,  99 mTc,  124 I,  125 I,  131 I,  89 Zr, and  99 mTc. 
     
     
         13 . The method of  claim 1  wherein the first or second binding agent comprises an antibody or antigen binding portion or derivative thereof capable of binding the extracellular domain of PSMA. 
     
     
         14 . (canceled) 
     
     
         15 . The method of  claim 1  wherein the first or second binding agent has an affinity of at least about 10 −9  M for at least the first or the second molecular target. 
     
     
         16 . (canceled) 
     
     
         17 . The method of  claim 3  further comprising administering an image contrast agent in conjunction with the diagnostic dose of a detectably labeled first binding agent. 
     
     
         18 . The method of  claim 1  further comprising administering a therapeutic dose of the second binding agent to the patient. 
     
     
         19 . A kit for cancer therapy comprising:
 a detectably labeled first binding agent, the detectably labeled binding agent being capable of binding a molecular target; and   instruction for selecting a patient for administration of a therapeutic dose of a second binding agent capable of binding a second molecular target, wherein the selected patient exhibits a positive reading for the detectably labeled first binding agent.   
     
     
         20 . The kit of  claim 19  wherein the cancer is a prostate cancer and wherein the molecular target comprises an extracellular domain of Prostate Specific Membrane Antigen (PSMA). 
     
     
         21 . The kit of  claim 19  further comprising a therapeutic dose of the second binding agent. 
     
     
         22 . The kit of  claim 19  further comprising an image contrast agent. 
     
     
         23 . The kit of  claim 19  wherein the first and the second molecular target are selected to be substantially the same. 
     
     
         24 . A method for treating cancer comprising:
 selecting a first and a second molecular target from a pathway related to cancer;   assessing the presence of a detectably labeled first binding agent in a tissue, cell or bodily fluid in a patient, wherein the first binding agent is capable of binding a first molecular target and wherein the presence of the first binding agent is indicative of cancer;   administering a therapeutic dose of a second binding agent capable of binding a second molecular target to a selected patient, wherein the patient is selected if the first binding agent is present.   
     
     
         25 . The method of  claim 24  wherein the cancer is a prostate cancer and wherein the molecular target comprises an extracellular domain of Prostate Specific Membrane Antigen (PSMA). 
     
     
         26 . The method of  claim 24  wherein the first and second molecular targets are substantially the same.