None listed
Conditions
Brief summary
The primary purpose of this trial is to determine the ideal dose of estradiol to give to men receiving androgen deprivation therapy (ADT) for prostate cancer, in order to replace the normal estradiol levels that they would have if they were not taking ADT. Who is it for? You may be eligible to participate in this trial if you are aged 55 to 80 years of age, and have been diagnosed with non-metastatic Prostate Cancer (T1-3NxM0) for which you are receiving treatment with GnRH agonists to suppress androgen production with a planned duration of further treatment of greater than 4 weeks. Study details All participants enrolled in this trial will be randomly allocated (by chance) to one of three groups. The first group will receive 0.9mg per day of estradiol, the second group will receive 1.8mg per day of estradiol, and the third group will receive a placebo (sham) treatment which contains no active ingredient. All three treatments are given as a gel which is rubbed into the skin once per day for 4 weeks. Researchers will take weekly blood samples from baseline to the end of the 4 week treatment period to determine the impact of each treatment on the level of estradiol in the blood as well as some indicators of bone health and diabetes, and a diary of hot flushes will be completed by all participants. It is hoped that this trial will provide information on the optimal dose of estradiol to give to men with prostate cancer on ADT, to replace the normal blood (serum) level of estradiol that they would have had were they not taking ADT. A subsequent study will investigate whether this treatment is effective in reducing some of the side effects of ADT.
Interventions
Estradiol transdermal gel either 0.9mg per day or 1.8mg per day, applied from a metered dose syringe once daily anywhere on the skin of the trunk for 4 weeks. Adherence will be monitored by weighing returned syringes.
Sponsors
University of Melbourne
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Blinded (masking used) (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
Male
Age
55 Years to 85 Years
Healthy volunteers
No
Inclusion criteria
1) Men with Prostate Cancer without metastases to bone or viscera detectable on staging with computed tomography or bone scanning. 2) Receiving treatment with GnRH agonists to suppress androgen production with a planned duration of further treatment of greater than 4 weeks
Exclusion criteria
1) Impaired performance status (ECOG >1) 2) History of deep vein thrombosis or pulmonary embolism 3) Stroke, transient ischaemic attack, myocardial infarction, or angina within last 12 months 4) Systolic BP > 160 or DBP > 100 5) Symptomatic heart failure (NYHA class > 1) 6) History of breast cancer 7) Pre-existing osteoporosis 8) Prior treatment with glucocorticoids or bisphosphonates 9) Diabetes Mellitus 10) Alcohol dependence or recreational drug use
Outcome results
None listed