Principal Investigator:Bhasin, Shalender
Site Research Nurse(s):Schram, Haley, J.
Wilson, Lauren, Elizabeth
The purpose of this phase II trial is to determine the efficacy and safety of testosterone
replacement therapy (TRT) in improving the symptoms of androgen deficiency and health-related
quality of life in men with prostate cancer who have undergone radical prostatectomy.
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
- 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
- Men who have undergone radiation therapy
- Men receiving androgen deprivation therapy will be excluded.
- Hemoglobin <10 g/dL or >16.5 g/dL
- Severe untreated sleep apnea
- Allergy to sesame oil
- Uncontrolled heart failure
- Myocardial infarction, acute coronary syndrome, revascularization surgery, or stroke
within 3 months
- Serum creatinine >2.5 mg/dL; ALT 3x upper limit of normal;
- Hemoglobin A1c >7.5% or diabetes requiring insulin therapy
- Body mass index (BMI) >40 kg/m2
- Untreated depression. Subjects with depression who have been on stable anti-depressant
medication, or undergoing CBT for more than three months are eligible.
- Men with axis I psychiatric disorder, such as schizophrenia, will be excluded.
- 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
Protocol #: 18-733