Improving Quality of Life of Prostate Cancer Survivors With Androgen Deficiency

• Status: Recruiting
• Trial end date: 2024-01-01
• Target enrollment: 0
• Participant gender: Male

Summary

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Dana-Farber Cancer Institute; Shalendar Bhasin, MD
• Collaborator: National Institute on Aging (NIA)
• Treatments: Androgens; Methyltestosterone; Testosterone; Testosterone 17 beta-cypionate; Testosterone enanthate; Testosterone undecanoate

Criteria

Inclusion Criteria:

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

Exclusion Criteria:

• 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