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