None listed
Conditions
Brief summary
This study will evaluate the effect of estradiol on bone architecture and fat mass in men with prostate cancer. Who is it for? You may be eligible to join this study if you are male, and have been diagnosed with prostate cancer for which you are about to commence treatment with GnRH agonists or antagonists to suppress androgen production (Androgen Deprivation Therapy; ADT) Study details Participants in this study will be randomly allocated (by chance) to one of two groups. Participants in one group will apply estradiol gel to the skin once daily for six months. Participants in the other group will apply a placebo gel (contains no active ingredients) to the skin once daily for six months. Recent evidence suggests that in men, some important biological actions attributed to testosterone are mediated via its metabolite, estradiol, rather than directly via the androgen receptor. We propose to use ADT given to men with prostate cancer as a unique model of severe long-term untreated hypogonadism to investigate biological actions of estradiol when testosterone is reduced to castrate levels. On completion of treatment at six months, participants will undergo a high resolution peripheral quantitative computed tomography (HR-pCT) scan to assess bone architecture and a dual-energy X-ray absorptiometry (DEXA) scan to assess fat mass.
Interventions
Estradiol transdermal gel 0.9 mg/d (1mL daily) for 6 months
Sponsors
University of Melbourne
Study design
Allocation
Randomised controlled trial
Primary purpose
Treatment
Eligibility
Sex/Gender
Male
Age
18 No limit to No maximum
Healthy volunteers
No
Inclusion criteria
1. Men with prostate cancer receiving gonadotropin-releasing hormone agonists or antagonists to suppress androgen production 2. Androgen Deprivation Therapy intended to continue for at least 6 months 3. Able and willing to comply with the study protocol requirements
Exclusion criteria
1. Bone metastases within imaging fields detectable by conventional imaging (e.g. CT scanning, bone scanning) 2. Significantly impaired performance status (ECOG > 2) 3. Previous history of deep vein thrombosis or pulmonary embolism 4. Stroke, transient ischaemic attack, myocardial infarction, or angina within the previous 12 months 5. New York Heart Association class 3-4 heart failure 6. Systolic blood pressure of 160 mmHg or higher or diastolic blood pressure of 100 mmHg or higher, or both. 7. Previous history of breast cancer 8. Current oral glucocorticoid therapy 9. Any current or previous antiresorptive therapy 10. Recreational drug use, alcohol dependence, known HIV/AIDS or any disease which is likely to lead to serious illness or death within the study period 11. Inability to understand sufficient English to give informed consent.
Outcome results
None listed