Diagnosis of Prostate Cancer

Abstract

Methods for diagnosing prostate cancer, and differentiate prostate cancer from other prostate complications, and use of said method, and diagnosing and monitoring lymph gland metastasis, post operative examinations, and examinations during or after radiation, cytostatic, and androgen treatments are disclosed. The methods comprise injecting tracer-labelled PSA or hK2 specific antibodies, visualising PSA or hK2 producing tissue with the aid of a visualisation method, and diagnosing prostate cancer from the difference in visualisation.

1 - 24 . (canceled) 
     
     
         25 . A tracer-labelled free PSA, precursor forms of PSA, internally nicked forms of PSA, low molecular weight free PSA, standard weight free PSA, inactive mature PSA, truncated forms of PSA, glycosylation variants of PSA, BPSA, inactive pro-PSA or hK2 specific antibody. 
     
     
         26 . The tracer-labelled antibody according to  claim 25 , wherein said antibody is selected from the group consisting of 4D4, 5C3, 241, 2E9, H117, and 5A10, or fragment thereof, in respect of PSA, and 11B6, and 7G1, or fragment thereof, in respect of hK2. 
     
     
         27 . The tracer-labelled antibody according to  claim 25 , wherein said PSA or hK2 specific antibody is tracer-labelled with technetium-99m. 
     
     
         28 . A kit for diagnosing prostate cancer, comprising tracer-labelled free PSA, precursor forms of PSA, internally nicked forms of PSA, low molecular weight free PSA, standard weight free PSA, inactive mature PSA, truncated forms of PSA, glycosylation variants of PSA, BPSA, inactive pro-PSA or hK2 specific antibodies, which antibodies are injectable in a body. 
     
     
         29 . The kit according to  claim 28 , wherein said antibody is selected from the group consisting of 4D4, 5C3, 241, 2E9, H117, and 5A10, or fragment thereof, in respect of PSA, and 11B6, and 7G1, or fragment thereof, in respect of hK2. 
     
     
         30 . The kit according to  claim 28 , wherein said antibody is tracer-labelled with technetium-99m. 
     
     
         31 . Tracer-labelled free PSA, precursor forms of PSA, internally nicked forms of PSA, low molecular weight free PSA, standard weight free PSA, inactive mature PSA, truncated forms of PSA, glycosylation variants of PSA, BPSA, inactive pro-PSA or hK2 specific antibody for use in visualising PSA or hK2 producing tissue. 
     
     
         32 . Tracer-labelled free PSA, precursor forms of PSA, internally nicked forms of PSA, low molecular weight free PSA, standard weight free PSA, inactive mature PSA, truncated forms of PSA, glycosylation variants of PSA, BPSA, inactive pro-PSA or hK2 specific antibody for use in diagnosing prostate cancer. 
     
     
         33 . Use of tracer-labelled free PSA, precursor forms of PSA, internally nicked forms of PSA, low molecular weight free PSA, standard weight free PSA, inactive mature PSA, truncated forms of PSA, glycosylation variants of PSA, BPSA, inactive pro-PSA or hK2 specific in a kit for diagnosing prostate cancer. 
     
     
         34 . A method for diagnosing prostate cancer, and differentiate prostate cancer from other prostate complications, said method comprising the steps of
 injecting tracer-labelled free PSA, precursor forms of PSA, internally nicked forms of PSA, low molecular weight free PSA, standard weight free PSA, inactive mature PSA, truncated forms of PSA, glycosylation variants of PSA, BPSA, inactive pro-PSA or hK2 specific antibodies in a body,   visualising PSA or hK2 producing tissue with the aid of a visualisation method, and   diagnosing prostate cancer in said body from the difference in visualisation.   
     
     
         35 . Method according to  claim 34 , wherein said diagnosing is obtained by difference in visualisation of PSA producing tissue. 
     
     
         36 . Method according to  claim 34 , wherein said diagnosing is obtained by difference in visualisation of hK2 producing tissue. 
     
     
         37 . Method according to  claim 34 , wherein a PSA visualisation and a hK2 visualisation are combined, and said diagnosing is performed by difference in visualisation of PSA and hK2 producing tissue. 
     
     
         38 . Method according to  claim 37 , wherein the PSA visualisation is performed before the hK2 visualisation. 
     
     
         39 . Method according to  claim 37 , wherein the hK2 visualisation is performed before the PSA visualisation. 
     
     
         40 . Method according to  claim 34 , wherein said visualisation is a radiologic visualisation, such as PET-scan. 
     
     
         41 . Method according to  claim 34 , wherein said tracer-labelled PSA antibodies bind to an antigen selected from the group consisting of free PSA, precursor forms of PSA, internally nicked forms of PSA, low molecular weight free PSA, standard weight free PSA, inactive mature PSA, truncated forms of PSA, glycosylation variants of PSA, BPSA, and inactive pro-PSA. 
     
     
         42 . Method according to  claim 34 , wherein said tracer-labelled hK2 antibodies bind to an antigen selected from the group consisting of all isomeric forms of hK2, and any molecule or protein in complex with, or bound to, hK2, selected from the group consisting of protein C inhibitor (PCI) or other extracellular protease inhibitors, such as α 2 -antiplasmin (α 2 -AP), ACT, AMG, anti-thrombin III (ATIII), C1-inactivator and plasminogen activator inhibitor-1 (PAI-1). 
     
     
         43 . Method according to  claim 34 , wherein said antibodies are human. 
     
     
         44 . Method according to  claim 34 , wherein said antibodies are selected from the group consisting of 4D4, 5C3, 241, 2E9, H117, and 5A10, or fragment thereof, in respect of PSA, and 11B6, and 7G1, or fragment thereof, in respect of hK2. 
     
     
         45 . Method according to  claim 34 , wherein said tracer-label is technetium-99m. 
     
     
         46 . Method according to  claim 34 , wherein said method is combined with other radiological visualisation methods, such as computed tomography (CT), computerized axial tomography (CAT), or magnetic resonance tomography (MRT). 
     
     
         47 . Method for examination, or monitoring, of lymph gland metastasis, post operative examinations, and examinations during or after radiation, cytostatic, and androgen treatments, said method comprising the steps of
 injecting tracer-labelled free PSA, precursor forms of PSA, internally nicked forms of PSA, low molecular weight free PSA, standard weight free PSA, inactive mature PSA, truncated forms of PSA, glycosylation variants of PSA, BPSA, inactive pro-PSA or hK2 specific antibodies,   visualising PSA or hK2 producing tissue with the aid of a visualisation method, such as PET-scan, and   diagnosing prostate cancer from the difference in visualisation.