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Completed
NCT03716739
Improving Quality of Life of Prostate Cancer Survivors With Androgen Deficiency
Conditions: Prostate Cancer
Sex: Male
Ages: 40 Years – N/A
Healthy volunteers: No
Phase: PHASE2
Enrollment: 136
Sponsor: Dana-Farber Cancer Institute
Location: Johns Hopkins University Baltimore Maryland
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.
Eligibility 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 \ 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 \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
Source: ClinicalTrials.gov (NCT03716739). StuddyBuddy aggregates publicly available trial information.