A Novel Liver Targeted Testosterone Therapy for Sarcopenia in Androgen Deprived Men with Prostate Cancer - A Blinded Randomized Controlled Trial
Metro South Health and Hospital Service
50 participants
Aug 8, 2016
Interventional
Conditions
Summary
The primary purpose of this trial is to evaluate the efficacy of oral testosterone for the prevention and treatment of sarcopenia in men with prostate cancer on Androgen Deprivation Therapy (ADT). Who is it for? You may be eligible to participate in this trial if you are aged 18 or over and have been diagnosed with prostate cancer, for which you are undergoing ADT. Study details All participants enrolled in this study will be randomly allocated (by chance) to receive either oral testosterone once per day for six months, or to receive an inactive sham tablet once per day for six months. All participants will be reviewed for sarcopenia by assessment of muscle mass with DEXA at six months, and for prostate cancer progression by PSA. It is hoped that the findings from this trial will provide information on the efficacy of oral testosterone for the prevention of sarcopenia in patients commencing ADT and the reversal of sarcopenia in patients on long term ADT, whilst evaluating whether this treatment has any impact on prostate cancer progression.
Eligibility
Plain Language Summary
Simplified for easier understanding
This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.
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Interventions
40mg oral testosterone daily for 6 months Will monitor adherence by patient log and drug packet return
Locations(2)
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ACTRN12616001166460