GALECTIN-3 AS A MARKER FOR PROSTATE CANCER

1 .- 54 . (canceled)

55 . A kit for improving the reliability of prostate specific antigen (PSA)-based prostate cancer progression testing comprising at least one galectin-3 detection assay and at least one PSA detection assay.

56 . A kit of claim 55 , further comprising instructions for performing the detection assays and instructions for determining whether the subject has progressed prostate cancer.

57 . A kit of claim 56 , wherein the instructions comprise reference levels.

58 . A kit of claim 56 , further comprising reference samples for determining reference levels of galectin-3 and PSA.

59 . A method for monitoring the progression of prostate cancer in a subject comprising:

determining a galectin-3 level and a prostate specific antigen (PSA) level in a biological sample obtained from the subject;

comparing the measured galectin-3 level with a galectin-3 reference level;

comparing the measured PSA level with a PSA reference level; and

determining that the prostate cancer has progressed if the level of galectin-3 in the biological sample is significantly elevated compared to the galectin-3 reference level and the level of PSA in the biological sample is significantly elevated compared to the PSA reference level;

wherein the method is more reliable at monitoring the progression of prostate cancer than a method that utilizes a prostate specific antigen (PSA) test alone.

60 . A method of claim 59 , wherein the galectin-3 reference level and/or PSA reference level are individually derived from (i) an individual who does not have prostate cancer, (ii) a group of individuals who do not have prostate cancer; (iii) the subject before diagnosis with prostate cancer; or (iv) the subject at the beginning of a treatment regimen for prostate cancer.

61 . A method of claim 59 , wherein the biological sample is a blood sample, a plasma sample, or a serum sample.

62 . A method for improving the reliability of PSA-based prostate cancer progression testing comprising:

determining a galectin-3 level and a prostate specific antigen (PSA) level in a biological sample obtained from the subject;

comparing the measured galectin-3 level with a galectin-3 reference level;

comparing the measured PSA level with a PSA reference level; and

determining that the prostate cancer has progressed if the level of galectin-3 in the biological sample is significantly elevated compared to the galectin-3 reference level and the level of PSA in the biological sample is significantly elevated compared to the PSA reference level;

wherein the reliability of the method for prostate cancer progression testing is more reliable than a method that utilizes a prostate specific antigen (PSA) test alone.

63 . A method of claim 62 , wherein the galectin-3 reference level and/or PSA reference level are individually derived from (i) an individual who does not have prostate cancer, (ii) a group of individuals who do not have prostate cancer; (iii) the subject before diagnosis with prostate cancer; or (iv) the subject at the beginning of a treatment regimen for prostate cancer.

64 . A method of claim 62 , wherein the biological sample is a blood sample, a plasma sample, or a serum sample.