Methods of treating or preventing prostate cancer

Abstract

In various embodiments, the present invention provides methods of treating and/or preventing prostate cancer and, in particular, the method comprising administering to a subject in need thereof a pharmaceutical composition comprising eicosapentaenoic acid or a derivative thereof.

1 . A method of treating or preventing prostate cancer in a subject having an elevated PSA level of at least about 2.5 ng/mL and a fasting baseline triglyceride level of at least about 500 mg/dL, the method comprising administering to the subject a pharmaceutical composition comprising about 1 g to about 4 g of ethyl eicosapentaenoate daily. 
     
     
         2 . The method of  claim 1 , wherein triglycerides are reduced in the subject with no increase in an LDL-C level in the subject. 
     
     
         3 . The method of  claim 2 , wherein the reduction in triglycerides and the no increase in LDL-C level is in comparison to baseline, or in comparison to a second subject or subject group that has received a prostate cancer therapy but not the ethyl eicosapentaenoate. 
     
     
         4 . The method of  claim 1 , wherein ethyl eicosapentaenoate represents at least about 96%, by weight of all fatty acids (and/or derivatives thereof) present in the pharmaceutical composition. 
     
     
         5 . The method of  claim 1 , wherein docosahexaenoic acid and its esters represent no more than about 4%, by weight of all fatty acids (and/or derivatives thereof) present in the pharmaceutical composition. 
     
     
         6 . The method of  claim 1 , wherein the subject has a risk factor associated with prostate cancer. 
     
     
         7 . The method of  claim 6 , wherein the risk factor is selected from the group consisting of: a genetic risk factor, a family history risk factor, a dietary risk factor, a viral risk factor, a sexual-related risk factor, a risk factor associated with exposure to medication, and a risk factor associated with a medical procedure. 
     
     
         8 . The method of  claim 7 , wherein the genetic risk factor comprises a mutation in BRCA1, a mutation in BRCA2, a mutation in HPC1, a mutation in the androgen receptor, a mutation in the vitamin D receptor, overexpression of one or more ETS transcription factors, a mutation in or loss of one or more copies of PTEN, a mutation in or loss of one or more copies of KAI1, a mutation in or loss of one or more copies of E-cadherin, a mutation in or loss of one or more copies of CD44, a TT allele pair at SNP rs10993994, a mutation in the promoter region of the MSMB gene, or a combination thereof. 
     
     
         9 . The method of  claim 1 , wherein the subject is identified as having prostate cancer before administration of the pharmaceutical composition to the subject. 
     
     
         10 . The method of  claim 9 , wherein the method further comprises providing the subject with a prostate cancer therapy selected from the group consisting of: surveillance, surgery, radiation, ultrasound, chemotherapy, cryotherapy, primary hormone therapy, and combinations thereof. 
     
     
         11 . The method of  claim 10 , the method further comprising reducing or discontinuing the prostate cancer therapy after administration of the pharmaceutical composition. 
     
     
         12 . The method of  claim 11 , wherein the prostate cancer therapy is reduced or discontinued after administration of the pharmaceutical composition for a period of time effective to reduce a prostate cancer diagnostic result associated with the subject. 
     
     
         13 . The method of  claim 12 , wherein the prostate cancer diagnostic result is one or more of: a PSA score, a prostate ultrasound image, a prostate MRI image, a biopsy sample, a Gleason score, and a prostate tumor grade. 
     
     
         14 . The method of  claim 12 , wherein the period of time is less than about 6 months. 
     
     
         15 . The method of  claim 14 , wherein the period of time is about 12 weeks. 
     
     
         16 . (canceled) 
     
     
         17 . The method of  claim 1 , the method further comprises determining a second, lower PSA level associated with the subject after administration of the pharmaceutical composition. 
     
     
         18 . The method of  claim 17 , wherein the pharmaceutical composition is administered to the subject for a period of time effective to reduce the PSA level by at least about 50%. 
     
     
         19 - 20 . (Canceled)