Identification and treatment of estrogen responsive prostate tumors
The present invention is directed to specific chromosomal rearrangements that are associated with prostate tumors that respond to compounds acting at estrogen receptors. Patients having the TMPRSS2-ERG fusion, may be treated with agonists of the estrogen beta receptor or antagonists of the estrogen alpha receptor.
1. A method of treating a patient for a prostate tumor comprising:
a) assaying cells derived from said tumor to determine whether said cells carry a TMPRSS2/ERG chromosomal rearrangement;
b) if the assay of paragraph a) indicates that said chromosomal rearrangement is present, administering to said patient a selective estrogen receptor modulator (SERM), wherein said SERM is an antagonist of the estrogen alpha receptor in prostate cells.
2. The method of claim 1 , wherein said SERM is administered to said patient orally.
3. The method of claim 2 , wherein said SERM is administered to said patient at a dose of 0.2-40 mg per kg body weight per day.
4. The method of claim 2 , wherein said SERM is administered to said patient at a dose of 0.2-5 mg per kg body weight per day.
5. The method of claim 1 , wherein said SERM is administered to said patient by injection.
6. The method of claim 1 , wherein said SERM is ormeloxifene.
7. The method of claim 6 , wherein said ormeloxifene is administered to said patient orally.
8. The method of claim 7 , wherein said ormeloxifene is administered to said patient at a dose of 0.2-40 mg per kg body weight per day.
9. The method of claim 7 , wherein said ormeloxifene is administered to said patient at a dose of 0.2-5 mg per kg body weight per day.
10. The method of claim 6 , wherein said ormeloxifene is administered to said patient by injection.
11. The method of claim 1 , wherein said SERM is fulvestrant and said fulvestrant is administered to said patient orally.
12. The method of claim 1 , wherein said SERM is fulvestrant and said fulvestrant is administered to said patient at a dose of 0.2-40 mg per kg body weight per day.
13. The method of claim 1 , wherein said fulvestrant is administered to said patient orally at 300-600 mg of fulvestrant per day.
14. The method of claim 1 , wherein the assay of prostate cells in step a) is carried out using a fluorescence in situ hybridization (FISH) assay.
15. The method of claim 1 , wherein cells derived from said tumor are obtained from said patient by biopsy or during surgery for said prostate tumor and said SERM is at least preferential in its action.
16. The method of claim 15 , wherein cells derived from said tumor are obtained by biopsy and said SERM is administered by injection.
17. The method of claim 15 , wherein said SERM is fulvestrant.
18. A method of treating a patient for a prostate tumor comprising:
a) assaying cells derived from said tumor to determine whether said cells carry a TMPRSS2/ERG chromosomal rearrangement;
b) if the assay of paragraph a) indicates that said chromosomal rearrangement is present, administering to said patient fulvestrant.
19. The method of claim 18 , wherein said fulvestrant is administered to said patient by injection.
20. The method of claim 19 , wherein said patient is administered 10-40 mg of said fulvestrant per day im.