Improving Quality of Life of Prostate Cancer Survivors With Androgen Deficiency

Prior treatment

• Men who have undergone radiation therapy
• Men receiving androgen deprivation therapy will be excluded.
• Untreated depression. Subjects with depression who have been on stable anti-depressant medication, or undergoing CBT for more than three months are eligible.
• Subjects who have used the following medications within the past 6 months: testosterone, DHEA, estrogens, GnRH analogs, antiandrogens, spironolactone, ketoconazole, rhGH, megestrol acetate, prednisone 20 mg daily or equivalent doses of other glucocorticoids for more than two weeks

Other illness

• Allergy to sesame oil
• Uncontrolled heart failure
• Myocardial infarction, acute coronary syndrome, revascularization surgery, or stroke within 3 months
• Men with axis I psychiatric disorder, such as schizophrenia, will be excluded.

Lab values

• Hemoglobin \<10 g/dL or \>16.5 g/dL
• Serum creatinine \>2.5 mg/dL; ALT 3x upper limit of normal;
• Hemoglobin A1c \>7.5% or diabetes requiring insulin therapy

Other

• Severe untreated sleep apnea
• Body mass index (BMI) \>40 kg/m2

• Men with prostate cancer, who have Stage pT2, N0, M0 lesions (confined to the gland); Combined Gleason score of 7 (3+4 elements) or less; Preoperative PSA less than 10 ng/ml; Stable and undetectable PSA level (PSA less than 0.1 ng/mL using an assay that has a functional sensitivity of 0.1 ng/mL) for at least two years after radical prostatectomy.
• Age: 40 years and older
• Presence of symptoms related to sexual dysfunction, fatigue/low vitality, or physical dysfunction.
• An average of two fasting, early morning serum testosterone levels, measured by LC-MS/MS, less than 275 mg/dL and/or free testosterone by equilibrium dialysis \<60 pg/mL. middle-aged and older men with mean testosterone levels \> 300 ng/dL.
• Ability and willingness to provide informed consent