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

Inclusion Criteria2

  • All men with prostate cancer on Androgen Deprivation therapy
  • no time limit regarding diagnosis

Exclusion Criteria4

  • % increase in PSA or increase in PSA to >4nmol/L above baseline after commencement of intervention
  • Previous Thyroid Dysfunction
  • Serious adverse event caused by product
  • Participants decision to withdrawl

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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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