Effect of Flutamide on Biomarkers in Blood and Tissue Samples From Patients at High Risk of Ovarian Cancer

Inclusion Criteria for all patients:

* ≥ 18 years of age
* Able to comply with study and follow-up requirements

Inclusion Criteria for high risk patients:

* elected to undergo prophylactic salpingo-oophorectomy
* fertile patients must use effective non-hormonal contraception
* agreed to use a nonhormonal means of contraception before surgery
* serum bilirubin ≤ 1.0 x Upper Limit Normal (ULN), alkaline phosphatase, Aspartate Aminotransferase (AST), and Alanine Aminotransferase (ALT) ≤ 2.5 x ULN
* serum creatinine ≤ 1.5 x ULN
* granulocyte count ≥ 1500/μL
* platelet count ≥ 75,000/μL
* hemoglobin ≥ 9 g/dL
* adequate complete blood count
* At high risk for developing ovarian cancer, as defined by any of the following:
* Breast Cancer carried a BRCA1 or BRCA2 deleterious mutation, a Lynch syndrome mutation, and/or defined by a family history of: 1 first-degree relative with epithelial ovarian cancer, ≥1 first-degree female relative with breast cancer when ≤40 years old, ≥1 first-degree female relative with breast cancer when ≤50 years old, male relative with breast cancer, and/or family history of breast cancer or ovarian cancer.

Inclusion Criteria for low risk patients:

* planning to undergo oophorectomy for a medical indication
* did not fulfill criteria for high risk of developing ovarian cancer

Exclusion criteria:

* liver disease, current alcohol abuse, or cirrhosis
* pregnancy or lactation
* current use of hormone therapy
* active treatment for cancer
* recent, current, or planned participation in another experimental drug study
* breast cancer within the past 5 years
* significant traumatic injury within the past 6 months
* major surgery within the past 6 months
* any disease, physical examination findings, or clinical laboratory findings giving reasonable suspicion of a disease or condition that contraindicates the continued use of an investigational drug or that may render the patient at high risk from treatment complication