RecruitingPhase 2ACTRN12616001166460

A Novel Liver Targeted Testosterone Therapy for Sarcopenia in Androgen Deprived Men with Prostate Cancer - A Blinded Randomized Controlled Trial


Sponsor

Metro South Health and Hospital Service

Enrollment

50 participants

Start Date

Aug 8, 2016

Study Type

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

Sex: MalesMin Age: 18 Yearss

Plain Language Summary

Simplified for easier understanding

This study is for men with prostate cancer who are receiving androgen deprivation therapy (ADT) — a hormone treatment that lowers testosterone to slow cancer growth. A major side effect of ADT is muscle loss (sarcopenia), which causes weakness and reduces quality of life. This trial tests whether taking a low-dose oral testosterone supplement can prevent or reverse this muscle loss without making the cancer worse. You may be eligible if: - You are a male aged 18 or older - You have prostate cancer - You are currently receiving androgen deprivation therapy (ADT) You may NOT be eligible if: - Your PSA rises significantly after starting the study treatment - You have a history of thyroid problems - You have had a serious side effect from the study product - You decide to withdraw from the study Talk to your doctor about whether this trial might be right for you.

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

40mg oral testosterone daily for 6 months Will monitor adherence by patient log and drug packet return


Locations(2)

Princess Alexandra Hospital - Woolloongabba

QLD, Australia

Greenslopes Private Hospital - Greenslopes

QLD, Australia

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ACTRN12616001166460


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