LOGIN
CREATE ACCOUNT
LOGIN
CREATE ACCOUNT
MY TRIALS
REGISTER TRIAL
FAQs
HINTS AND TIPS
DEFINITIONS
Trial Review
COVID-19 studies are our top priority. For all other trials, there is a 4-week delay in processing a trial submitted/resubmitted to the ANZCTR and additional delays for updates of registered trials. We appreciate your patience.
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this
information for consumers
Download to PDF
Trial registered on ANZCTR
Registration number
ACTRN12614000689673
Ethics application status
Approved
Date submitted
12/06/2014
Date registered
30/06/2014
Date last updated
10/07/2019
Date data sharing statement initially provided
10/07/2019
Type of registration
Prospectively registered
Titles & IDs
Public title
Biological actions of estradiol in men trial
Query!
Scientific title
The effects of estradiol on bone architecture and fat mass in men with prostate cancer
Query!
Secondary ID [1]
284785
0
Nil
Query!
Universal Trial Number (UTN)
Query!
Trial acronym
BAEMT
Query!
Linked study record
Query!
Health condition
Health condition(s) or problem(s) studied:
Bone loss
292161
0
Query!
Prostate Cancer
292245
0
Query!
Hypogonadism
304421
0
Query!
Condition category
Condition code
Musculoskeletal
292498
292498
0
0
Query!
Osteoporosis
Query!
Cancer
292542
292542
0
0
Query!
Prostate
Query!
Metabolic and Endocrine
303752
303752
0
0
Query!
Other endocrine disorders
Query!
Intervention/exposure
Study type
Interventional
Query!
Description of intervention(s) / exposure
Estradiol transdermal gel 0.9 mg/d (1mL daily) for 6 months
Query!
Intervention code [1]
289576
0
Treatment: Drugs
Query!
Comparator / control treatment
Matching placebo transdermal gel 1mL daily for 6 months
Query!
Control group
Placebo
Query!
Outcomes
Primary outcome [1]
292358
0
Total volumetric bone mineral density at tibia measured by high resolution peripheral quantitative computed tomography (HR-pQCT).
Query!
Timepoint [1]
292358
0
6 months
Query!
Primary outcome [2]
303622
0
Total fat mass by DEXA scan
Query!
Timepoint [2]
303622
0
6 months
Query!
Secondary outcome [1]
337926
0
Bone remodeling markers (P1NP, CTX) assessed by serum assay.
Query!
Timepoint [1]
337926
0
6 months
Query!
Secondary outcome [2]
337927
0
Cortical porosity as measured by HR-pQCT
Query!
Timepoint [2]
337927
0
6 months
Query!
Secondary outcome [3]
337928
0
Visceral and subcutaneous abdominal fat by DEXA scan
Query!
Timepoint [3]
337928
0
6 months
Query!
Secondary outcome [4]
337929
0
Lean body mass by DEXA scan
Query!
Timepoint [4]
337929
0
6 months
Query!
Secondary outcome [5]
337930
0
Insulin resistance as estimated by HOMA-IR
Query!
Timepoint [5]
337930
0
6 months
Query!
Secondary outcome [6]
337931
0
Cognitive scores in 6 domains measured by a short cognitive battery
- Processing speed (Detection Test)
- Attention (Identification Test)
- Visual memory (One Card Learning Test)
- Working memory (One Back Test)
- Executive function (Groton Maze Learning Test)
- Verbal learning (International Shopping List Test)
Query!
Timepoint [6]
337931
0
6 months
Query!
Secondary outcome [7]
337932
0
Anatomical differences on brain MRI scanning (MPRAGE T1 anatomical images)
Query!
Timepoint [7]
337932
0
6 months
Query!
Secondary outcome [8]
337933
0
Trabecular number, thickness, separation and trabecular bone volume/tissue volume as measured by HR-pQCT
Query!
Timepoint [8]
337933
0
6 months
Query!
Secondary outcome [9]
337934
0
Functional MRI tasks
- Emotion Recognition
- Verbal Memory
- Mental Rotation
Query!
Timepoint [9]
337934
0
6 months
Query!
Secondary outcome [10]
337935
0
Areal bone mineral density as measured by DEXA scanning
Query!
Timepoint [10]
337935
0
6 months
Query!
Secondary outcome [11]
337993
0
Total volumetric bone mineral density at radius as measured by HR-pQCT.
Query!
Timepoint [11]
337993
0
6 months
Query!
Secondary outcome [12]
337994
0
Matrix mineral density as measured by HR-pQCT
Query!
Timepoint [12]
337994
0
6 months
Query!
Secondary outcome [13]
339661
0
Hot Flushes as measured by the Mayo Clinic Hot Flash Diary
Query!
Timepoint [13]
339661
0
6 months
Query!
Secondary outcome [14]
339662
0
Prostate cancer specific quality of life as measured by the FACT-P questionnaire.
Query!
Timepoint [14]
339662
0
6 months
Query!
Secondary outcome [15]
339663
0
Sexual function as measured by the IIEF-5 questionnaire
Query!
Timepoint [15]
339663
0
6 months
Query!
Secondary outcome [16]
339664
0
Hypogonadal symptoms as measured by the Aging Male Symptoms Score
Query!
Timepoint [16]
339664
0
6 months
Query!
Secondary outcome [17]
339665
0
Depression using the Hospital and Anxiety Depression Score
Query!
Timepoint [17]
339665
0
6 months
Query!
Secondary outcome [18]
372435
0
Cortical volumetric bone mineral density at tibia measured by HR-pQCT.
Query!
Timepoint [18]
372435
0
6 months
Query!
Secondary outcome [19]
372436
0
Cortical volumetric bone mineral density at radius measured by HR-pQCT.
Query!
Timepoint [19]
372436
0
6 months
Query!
Secondary outcome [20]
372437
0
Cortical area at distal tibia as measured by HR-pQCT.
Query!
Timepoint [20]
372437
0
6 months
Query!
Secondary outcome [21]
372438
0
Cortical area at distal radius as measured by HR-pQCT.
Query!
Timepoint [21]
372438
0
6 months
Query!
Secondary outcome [22]
372439
0
Structural fragility score derived from HR-pQCT parameters.
Query!
Timepoint [22]
372439
0
6 months
Query!
Eligibility
Key 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
Query!
Minimum age
No limit
Query!
Query!
Maximum age
No limit
Query!
Query!
Gender
Males
Query!
Can healthy volunteers participate?
No
Query!
Key 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.
Query!
Study design
Purpose of the study
Treatment
Query!
Allocation to intervention
Randomised controlled trial
Query!
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Query!
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Query!
Masking / blinding
Query!
Who is / are masked / blinded?
Query!
Query!
Query!
Query!
Intervention assignment
Query!
Other design features
Query!
Phase
Phase 2 / Phase 3
Query!
Type of endpoint(s)
Query!
Statistical methods / analysis
Query!
Recruitment
Recruitment status
Recruiting
Query!
Date of first participant enrolment
Anticipated
1/11/2017
Query!
Actual
8/11/2017
Query!
Date of last participant enrolment
Anticipated
30/06/2020
Query!
Actual
Query!
Date of last data collection
Anticipated
Query!
Actual
Query!
Sample size
Target
130
Query!
Accrual to date
64
Query!
Final
Query!
Recruitment in Australia
Recruitment state(s)
VIC
Query!
Recruitment hospital [1]
8815
0
Austin Health - Heidelberg Repatriation Hospital - Heidelberg West
Query!
Recruitment postcode(s) [1]
16939
0
3081 - Heidelberg West
Query!
Funding & Sponsors
Funding source category [1]
289401
0
Self funded/Unfunded
Query!
Name [1]
289401
0
Query!
Address [1]
289401
0
Query!
Country [1]
289401
0
Query!
Primary sponsor type
University
Query!
Name
University of Melbourne
Query!
Address
Dept. of Medicine
146 Studley Road
Heidelberg 3082
Victoria
Query!
Country
Australia
Query!
Secondary sponsor category [1]
288083
0
Hospital
Query!
Name [1]
288083
0
Austin Health
Query!
Address [1]
288083
0
146 Studley Road
Heidelberg 3082
Victoria
Query!
Country [1]
288083
0
Australia
Query!
Ethics approval
Ethics application status
Approved
Query!
Ethics committee name [1]
291161
0
Austin Health
Query!
Ethics committee address [1]
291161
0
146 Studley Road
Heidelberg 3082
Victoria
Query!
Ethics committee country [1]
291161
0
Australia
Query!
Date submitted for ethics approval [1]
291161
0
01/08/2014
Query!
Approval date [1]
291161
0
08/08/2017
Query!
Ethics approval number [1]
291161
0
HREC/16/Austin/98
Query!
Summary
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.
Query!
Trial website
Query!
Trial related presentations / publications
Query!
Public notes
Query!
Contacts
Principal investigator
Name
49154
0
A/Prof Mathis Grossmann
Query!
Address
49154
0
Department of Medicine Austin Health
The University of Melbourne
145 Studley Road, Heidelberg, VIC 3084, Australia
Query!
Country
49154
0
Australia
Query!
Phone
49154
0
+61394965000
Query!
Fax
49154
0
Query!
Email
49154
0
mathisg@unimelb.edu.au
Query!
Contact person for public queries
Name
49155
0
Dr Nicholas Russell
Query!
Address
49155
0
Department of Medicine Austin Health
The University of Melbourne
145 Studley Road, Heidelberg, VIC 3084, Australia
Query!
Country
49155
0
Australia
Query!
Phone
49155
0
+61394965000
Query!
Fax
49155
0
Query!
Email
49155
0
nicholas.russell@austin.org.au
Query!
Contact person for scientific queries
Name
49156
0
Dr Nicholas Russell
Query!
Address
49156
0
Department of Medicine Austin Health
The University of Melbourne
145 Studley Road, Heidelberg, VIC 3084, Australia
Query!
Country
49156
0
Australia
Query!
Phone
49156
0
+61394965000
Query!
Fax
49156
0
Query!
Email
49156
0
nicholas.russell@austin.org.au
Query!
Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Query!
No/undecided IPD sharing reason/comment
Query!
What supporting documents are/will be available?
Query!
Summary results
No Results
Download to PDF