Adjuvant therapy for use in prostate cancer treatment

Abstract

The present invention relates to the field of prostate cancer treatment, and in particular the field of prostate cancer treatment by Androgen Deprivation Therapy (ADT). The present treatment involves oral administration of an estetrol component in conjunction with ADT.

What is claimed is: 
     
         1 . A kit-of-parts comprising:
 (a) a first pharmaceutical composition comprising a GnRH agonist; and   (b) a second pharmaceutical composition adapted for oral administration, comprising 20 to 80 mg of estetrol.   
     
     
         2 . The kit-of-parts according to  claim 1 , wherein the GnRH agonist is selected from leuprolide, buserelin, goserelin, nafarelin, triptorelin and combinations thereof. 
     
     
         3 . The kit-of-parts according to  claim 1 , wherein the first pharmaceutical composition is adapted for intramuscular or subcutaneous administration and comprises leuprolide. 
     
     
         4 . The kit-of-parts according to  claim 1 , wherein the first pharmaceutical composition is adapted for subcutaneous or intranasal administration and comprises buserelin. 
     
     
         5 . The kit-of-parts according to  claim 1 , wherein the first pharmaceutical composition is adapted for subcutaneous administration and comprises goserelin. 
     
     
         6 . The kit-of-parts according to  claim 1 , wherein the first pharmaceutical composition is adapted for intranasal administration and comprises nafarelin. 
     
     
         7 . The kit-of-parts according to  claim 1 , wherein the first pharmaceutical composition is adapted for intramuscular administration and comprises triptoreline. 
     
     
         8 . The kit-of-parts according to  claim 1 , wherein the second pharmaceutical composition is present in the form of an oral dosage unit selected from tablets, capsules, cachets, pellets, pills, powders and granules. 
     
     
         9 . The kit-of-parts according to  claim 1 , wherein the second pharmaceutical composition comprises no more than 60 mg of estetrol. 
     
     
         10 . The kit-of-parts according to  claim 1 , further comprising instructions for use in treating prostate cancer. 
     
     
         11 . A method of treating prostate cancer in a patient by androgen deprivation therapy, the method comprising:
 (a) administering the first pharmaceutical composition from a kit-of-parts according to  claim 1 ; and   (b) oral co-administering of the second pharmaceutical composition from a kit-of-parts according to  claim 1 .   
     
     
         12 . The method according to  claim 11 , wherein the first pharmaceutical compositions comprises a GnRH agonist selected from leuprolide, buserelin, goserelin, nafarelin, triptorelin and combinations thereof. 
     
     
         13 . The method according to  claim 12 , wherein the first pharmaceutical composition comprises leuprolide and wherein the first pharmaceutical composition is administered intramuscularly or subcutaneously. 
     
     
         14 . The method according to  claim 12 , wherein the first pharmaceutical composition comprises buserelin and wherein the first pharmaceutical composition is administered subcutaneously or intranasally. 
     
     
         15 . The method according to  claim 12 , wherein the first pharmaceutical composition comprises goserelin and wherein the first pharmaceutical composition is administered subcutaneously. 
     
     
         16 . The method according to  claim 12 , wherein the first pharmaceutical composition comprises nafarelin and wherein the first pharmaceutical composition is administered intranasally. 
     
     
         17 . The method according to  claim 12 , wherein the first pharmaceutical composition comprises triptoreline and wherein the first pharmaceutical composition is administered intramuscularly. 
     
     
         18 . The method according to  claim 12 , wherein the second composition is co-administered once daily for at least 4 weeks. 
     
     
         19 . The method according to  claim 18 , wherein the second composition is co-administered once daily for at least 12 weeks. 
     
     
         20 . The method according to  claim 19 , wherein the second composition is co-administered once daily for at least 50 weeks. 
     
     
         21 . The method according to  claim 12 , wherein estetrol is administered in a daily dose of no more than 80 mg. 
     
     
         22 . The method according to  claim 21 , wherein estetrol is administered in a daily dose of no more than 60 mg. 
     
     
         23 . The method according to  claim 18 , wherein co-administration of the second pharmaceutical composition causes a further decrease of free testosterone levels compared to administration of the GnRH agonist alone. 
     
     
         24 . The method according to  claim 18 , wherein co-administration of the second pharmaceutical composition reduces loss of bone mineral density and/or reduces hot flushes.