Improving Quality of Life of Prostate Cancer Survivors With Androgen Deficiency (NCT03716739) | Clinical Trial Compass
CompletedPhase 2
Improving Quality of Life of Prostate Cancer Survivors With Androgen Deficiency
United States136 participantsStarted 2019-03-19
Plain-language 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.
Who can participate
Age range40 Years
SexMALE
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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 dis…