Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12614000689673
Ethics application status
Approved
Date submitted
12/06/2014
Date registered
30/06/2014
Date last updated
16/06/2021
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
Updated from
The effects of estradiol on bone architecture and fat mass in men with prostate cancer  
Reason: Update to be consistent with documents approved by HREC
Updated on 16/08/2017 1:29:31 PM
Scientific title
The effects of estradiol on bone architecture and fat mass in men with prostate cancer
Secondary ID [1] 284785 0
Nil
Universal Trial Number (UTN)
Trial acronym
BAEMT
Updated from
 
Reason: Adding acronym
Updated on 16/08/2017 1:29:31 PM
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Bone loss 292161 0
Prostate Cancer 292245 0
Hypogonadism 304421 0
Inserted
 
Reason: To be more comprehensive
Updated on 16/08/2017 1:29:31 PM
Condition category
Condition code
Musculoskeletal 292498 292498 0 0
Osteoporosis
Cancer 292542 292542 0 0
Prostate
Metabolic and Endocrine 303752 303752 0 0
Other endocrine disorders
Inserted
 

Reason: To be more comprehensive
Updated on 16/08/2017 1:29:31 PM
Inserted
 

Reason: To be more comprehensive
Updated on 16/08/2017 1:29:31 PM

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Estradiol transdermal gel 0.9 mg/d (1mL daily) for 6 months
Updated from
estradiol transdermal gel 1 mg/d for 6 months  
Reason: We have new pilot study data that supports this dose
Updated on 16/08/2017 1:29:31 PM
Intervention code [1] 289576 0
Treatment: Drugs
Comparator / control treatment
Matching placebo transdermal gel 1mL daily for 6 months
Updated from
placebo transdermal gel 1 mg/d for 6 months  
Reason: The placebo gel does not have a dose, only a volume to match the active intervention.
Updated on 16/08/2017 1:29:31 PM
Control group
Placebo

Outcomes
Primary outcome [1] 292358 0
Total volumetric bone mineral density at tibia measured by high resolution peripheral quantitative computed tomography (HR-pQCT).
Updated from
Cortical volumetric bone mineral density at tibia and radius measured by high resolution peripheral quantitative computed tomography (HR-pQCT)  
Reason: Recent evidence (Samelson et al 2019 Lancet Diabetes Endocrinology) showed total volumetric bone mineral density to be a better fracture predictor than cortical volumetric bone mineral density. As we remain blinded, we are taking the opportunity to elevate this from a secondary endpoint to the primary endpoint. This change was made after enrolment of 64 participants.
Updated on 10/07/2019 10:58:05 AM
Updated from
Bone architecture by CT scan  
Reason: Greater specificity
Updated on 16/08/2017 1:29:31 PM
Timepoint [1] 292358 0
6 months
Primary outcome [2] 303622 0
Total fat mass by DEXA scan
Inserted
 
Reason: This is a co-primary endpoint, not a secondary endpoint
Updated on 10/10/2017 1:03:49 PM
Timepoint [2] 303622 0
6 months
Inserted
 
Reason: This is a co-primary endpoint, not a secondary endpoint
Updated on 10/10/2017 1:03:49 PM
Secondary outcome [1] 337926 0
Bone remodeling markers (P1NP, CTX) assessed by serum assay.
Inserted
 
Reason: secondary endpoint
Updated on 16/08/2017 1:29:31 PM
Timepoint [1] 337926 0
6 months
Inserted
 
Reason: secondary endpoint
Updated on 16/08/2017 1:29:31 PM
Secondary outcome [2] 337927 0
Cortical porosity as measured by HR-pQCT
Updated from
Cortical porosity as measured by HR-pQCT and the StrAx algorithm.  
Reason: Analysis algorithm used may be StrAx or a competitor.
Updated on 10/10/2017 1:03:49 PM
Updated from
Cortical porosity, area, and tissue mineral density as measured by HR-pQCT and the StrAx1.0 algorithm  
Reason: clarity
Updated on 18/08/2017 11:30:17 AM
Inserted
 
Reason: secondary endpoint
Updated on 16/08/2017 1:29:31 PM
Timepoint [2] 337927 0
6 months
Inserted
 
Reason: secondary endpoint
Updated on 16/08/2017 1:29:31 PM
Secondary outcome [3] 337928 0
Visceral and subcutaneous abdominal fat by DEXA scan
Inserted
 
Reason: Secondary endpoint
Updated on 16/08/2017 1:29:31 PM
Timepoint [3] 337928 0
6 months
Inserted
 
Reason: Secondary endpoint
Updated on 16/08/2017 1:29:31 PM
Secondary outcome [4] 337929 0
Lean body mass by DEXA scan
Inserted
 
Reason: Secondary endpoint
Updated on 16/08/2017 1:29:31 PM
Timepoint [4] 337929 0
6 months
Inserted
 
Reason: Secondary endpoint
Updated on 16/08/2017 1:29:31 PM
Secondary outcome [5] 337930 0
Insulin resistance as estimated by HOMA-IR
Inserted
 
Reason: Secondary endpoint
Updated on 16/08/2017 1:29:31 PM
Timepoint [5] 337930 0
6 months
Inserted
 
Reason: Secondary endpoint
Updated on 16/08/2017 1:29:31 PM
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)
Inserted
 
Reason: Secondary endpoint
Updated on 16/08/2017 1:29:31 PM
Timepoint [6] 337931 0
6 months
Inserted
 
Reason: Secondary endpoint
Updated on 16/08/2017 1:29:31 PM
Secondary outcome [7] 337932 0
Anatomical differences on brain MRI scanning (MPRAGE T1 anatomical images)
Inserted
 
Reason: Secondary endpoint
Updated on 16/08/2017 1:29:31 PM
Timepoint [7] 337932 0
6 months
Inserted
 
Reason: Secondary endpoint
Updated on 16/08/2017 1:29:31 PM
Secondary outcome [8] 337933 0
Trabecular number, thickness, separation and trabecular bone volume/tissue volume as measured by HR-pQCT
Updated from
Trabecular number, thickness, separation and trabecular bone volume/tissue volume as measured by HR-pQCT and with analysis by the StrAx algorithm  
Reason: Analysis algorithm used may be StrAx or a competitor.
Updated on 10/10/2017 1:03:49 PM
Updated from
Trabecular volumetric bone mineral density, number, thickness and separation, measures by HR-pQCT  
Reason: clarity
Updated on 18/08/2017 11:30:17 AM
Inserted
 
Reason: Expanding on microarchitectural parameters to be assessed
Updated on 16/08/2017 1:29:31 PM
Timepoint [8] 337933 0
6 months
Inserted
 
Reason: Expanding on microarchitectural parameters to be assessed
Updated on 16/08/2017 1:29:31 PM
Secondary outcome [9] 337934 0
Functional MRI tasks - Emotion Recognition - Verbal Memory - Mental Rotation
Inserted
 
Reason: Defining fMRI parameters to be assessed
Updated on 16/08/2017 1:29:31 PM
Timepoint [9] 337934 0
6 months
Inserted
 
Reason: Defining fMRI parameters to be assessed
Updated on 16/08/2017 1:29:31 PM
Secondary outcome [10] 337935 0
Areal bone mineral density as measured by DEXA scanning
Inserted
 
Reason: Adding secondary endpoint
Updated on 16/08/2017 1:29:31 PM
Timepoint [10] 337935 0
6 months
Inserted
 
Reason: Adding secondary endpoint
Updated on 16/08/2017 1:29:31 PM
Secondary outcome [11] 337993 0
Total volumetric bone mineral density at radius as measured by HR-pQCT.
Updated from
Total volumetric bone mineral density as measured by HR-pQCT  
Reason: Re-writing for specificity given total volumetric bone mineral density at tibia has been elevated to a primary endpoint. This change was made after enrolment of 64 participants.
Updated on 10/07/2019 10:58:05 AM
Inserted
 
Reason: adding HR-pQCT parameter
Updated on 18/08/2017 11:30:17 AM
Timepoint [11] 337993 0
6 months
Inserted
 
Reason: adding HR-pQCT parameter
Updated on 18/08/2017 11:30:17 AM
Secondary outcome [12] 337994 0
Matrix mineral density as measured by HR-pQCT
Updated from
Matrix mineral density as measured by HR-pQCT and the StrAx algorithm  
Reason: Trabecular number, thickness, separation and trabecular bone volume/tissue volume as measured by HR-pQCT
Updated on 10/10/2017 1:03:49 PM
Inserted
 
Reason: Adding HR-pQCT parameter
Updated on 18/08/2017 11:30:17 AM
Timepoint [12] 337994 0
6 months
Inserted
 
Reason: Adding HR-pQCT parameter
Updated on 18/08/2017 11:30:17 AM
Secondary outcome [13] 339661 0
Hot Flushes as measured by the Mayo Clinic Hot Flash Diary
Inserted
 
Reason: Secondary outcome
Updated on 10/10/2017 1:03:49 PM
Timepoint [13] 339661 0
6 months
Inserted
 
Reason: Secondary outcome
Updated on 10/10/2017 1:03:49 PM
Secondary outcome [14] 339662 0
Prostate cancer specific quality of life as measured by the FACT-P questionnaire.
Inserted
 
Reason: Secondary outcome
Updated on 10/10/2017 1:03:49 PM
Timepoint [14] 339662 0
6 months
Inserted
 
Reason: Secondary outcome
Updated on 10/10/2017 1:03:49 PM
Secondary outcome [15] 339663 0
Sexual function as measured by the IIEF-5 questionnaire
Inserted
 
Reason: Secondary outcome
Updated on 10/10/2017 1:03:49 PM
Timepoint [15] 339663 0
6 months
Inserted
 
Reason: Secondary outcome
Updated on 10/10/2017 1:03:49 PM
Secondary outcome [16] 339664 0
Hypogonadal symptoms as measured by the Aging Male Symptoms Score
Inserted
 
Reason: Secondary endpoint
Updated on 10/10/2017 1:03:49 PM
Timepoint [16] 339664 0
6 months
Inserted
 
Reason: Secondary endpoint
Updated on 10/10/2017 1:03:49 PM
Secondary outcome [17] 339665 0
Depression using the Hospital and Anxiety Depression Score
Inserted
 
Reason: Secondary outcome
Updated on 10/10/2017 1:03:49 PM
Timepoint [17] 339665 0
6 months
Inserted
 
Reason: Secondary outcome
Updated on 10/10/2017 1:03:49 PM
Secondary outcome [18] 372435 0
Cortical volumetric bone mineral density at tibia measured by HR-pQCT.
Inserted
 
Reason: Changing this from a primary to a secondary endpoint. This change was made after enrolment of 64 participants.
Updated on 10/07/2019 10:58:05 AM
Timepoint [18] 372435 0
6 months
Inserted
 
Reason: Changing this from a primary to a secondary endpoint.
Updated on 10/07/2019 10:58:05 AM
Secondary outcome [19] 372436 0
Cortical volumetric bone mineral density at radius measured by HR-pQCT.
Inserted
 
Reason: Changing this from a primary to a secondary endpoint. This change was made after enrolment of 64 participants.
Updated on 10/07/2019 10:58:05 AM
Timepoint [19] 372436 0
6 months
Inserted
 
Reason: Changing this from a primary to a secondary endpoint
Updated on 10/07/2019 10:58:05 AM
Secondary outcome [20] 372437 0
Cortical area at distal tibia as measured by HR-pQCT.
Inserted
 
Reason: Including this missing HR-pQCT structural parameter. This change was made after enrolment of 64 participants.
Updated on 10/07/2019 10:58:05 AM
Timepoint [20] 372437 0
6 months
Inserted
 
Reason: Including this missing HR-pQCT structural parameter
Updated on 10/07/2019 10:58:05 AM
Secondary outcome [21] 372438 0
Cortical area at distal radius as measured by HR-pQCT.
Inserted
 
Reason: Including this missing HR-pQCT structural parameter. This change was made after enrolment of 64 participants.
Updated on 10/07/2019 10:58:05 AM
Timepoint [21] 372438 0
6 months
Inserted
 
Reason: Including this missing structural parameter
Updated on 10/07/2019 10:58:05 AM
Secondary outcome [22] 372439 0
Structural fragility score derived from HR-pQCT parameters.
Inserted
 
Reason: Including this derived HR-pQCT score given we are underpowered for fracture outcomes, and recent evidence that this might be a good fracture predictor (Zebaze JBMR Plus 2018). This change was made after enrolment of 64 participants.
Updated on 10/07/2019 10:58:05 AM
Timepoint [22] 372439 0
6 months
Inserted
 
Reason: Including this derived HR-pQCT score given we are underpowered for fracture outcomes, and recent evidence that this might be a good fracture predictor (Zebaze JBMR Plus 2018).
Updated on 10/07/2019 10:58:05 AM
Deleted Outcome
fat mass by DEXA scan  
Timepoint
6 months
Reason: This is a co-primary endpoint, not a secondary endpoint (correcting error)
Updated on 10/10/2017 1:03:49 PM

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
Updated from
1) Men with non-metastatic Prostate Cancer (PCa) (T1-3NxM0) 2) Age 55-80 about to commence treatment with GnRH agonists to suppress androgen production 3) ADT is intended for at least 6 months 4) Able and willing to comply with the study protocol requirements.  
Reason: We are removing age barriers to entry to maximise recruitment. We will include men with locally advanced and metastatic prostate cancer subject to exclusions (below). To maximise recruitment, we will enrol men commencing ADT or men already established on ADT.
Updated on 16/08/2017 1:29:31 PM
Minimum age
No limit
Updated from
55  
Reason: We are removing age barriers to entry to maximise recruitment.
Updated on 16/08/2017 1:29:31 PM
Updated from
Years  
Reason: We are removing age barriers to entry to maximise recruitment.
Updated on 16/08/2017 1:29:31 PM
Maximum age
No limit
Updated from
80  
Reason: We are removing age barriers to entry to maximise recruitment.
Updated on 16/08/2017 1:29:31 PM
Updated from
Years  
Reason: We are removing age barriers to entry to maximise recruitment.
Updated on 16/08/2017 1:29:31 PM
Sex
Males
Can healthy volunteers participate?
No
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.
Updated from
1) Impaired performance status (ECOG < 1). 2) Previous history of deep vein thrombosis or pulmonary embolism. 3) Stroke, transient ischaemic attack or myocardial infarction within the previous 12 months; angina or heart failure (New York Heart Association grade II or higher); systolic blood pressure of 160 mmHg or higher and, diastolic blood pressure of 100 mmHg or higher, or both. 4) Previous history of breast cancer.  
Reason: 1. Bone metastases within DEXA or HR-pQCT imaging fields will lead to artefact in results 2. Men will need to be able to comply with study protocol requirements and visits 3-7. Safety criterion 8-9. These will alter interpretation of bone density (primary outcome) 10. These will make it difficult to comply with 6 month study protocol or alter interpretation of bone density (primary outcome) 11. We are unable to provide qualified interpreters at all study visits.
Updated on 16/08/2017 1:29:31 PM

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Who is / are masked / blinded?



Intervention assignment
Other design features
Phase
Phase 2 / Phase 3
Updated from
 
Reason: Mandatory field
Updated on 10/07/2019 10:58:05 AM
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Stopped early
Updated from
Recruiting  
Reason: Recruitment stopped early because of COVID-19 pandemic.
Updated on 16/06/2021 7:37:01 AM
Updated from
Not yet recruiting  
Reason: Recruiting.
Updated on 11/09/2018 4:38:29 PM
Data analysis
Data collected is being analysed
Updated from
Please click 'Update' and select the most appropriate option.  
Reason: Data is being analysed as per original intention to treat protocol,
Updated on 16/06/2021 7:37:01 AM
Reason for early stopping/withdrawal
Other reasons/comments
Updated from
Please click 'Update' and select all that apply.  
Reason: -
Updated on 16/06/2021 7:37:01 AM
Other reasons
COVID-19 pandemic resulted in a human research ethics committee mandated shut down in recruitment. Further recruitment may have been possible in future from an ethics stand point but funding, staff, facilities were not able to be guaranteed for a future commencement of recruitment.
Updated from
 
Updated on 16/06/2021 7:37:01 AM
Date of first participant enrolment
Anticipated
1/11/2017
Actual
8/11/2017
Updated from
1/09/2017 
Reason: New anticipated recruitment open date
Updated on 10/10/2017 1:03:49 PM
Updated from
1/03/2017 
Reason: Planned recruitment start date
Updated on 16/08/2017 1:29:31 PM
Updated from
2/02/2015 
Reason: Pilot study dose finding study delayed
Updated on 7/02/2017 4:41:21 PM
Updated from
 
Reason: This was the actual date of first participant enrolment.
Updated on 11/09/2018 4:38:29 PM
Date of last participant enrolment
Anticipated
30/06/2020
Actual
27/02/2020
Updated from
31/12/2019 
Reason: Slower recruitment than anticipated.
Updated on 10/07/2019 10:58:05 AM
Updated from
 
Reason: Antipcated final participant enrolment
Updated on 11/09/2018 4:38:29 PM
Updated from
 
Reason: Last participant first visit
Updated on 16/06/2021 7:37:01 AM
Date of last data collection
Anticipated
Actual
24/08/2020
Updated from
 
Reason: Last participant last visit
Updated on 16/06/2021 7:37:01 AM
Sample size
Target
130
Accrual to date
Final
78
Updated from
64 
Reason: Recruitment complete
Updated on 16/06/2021 7:37:01 AM
Updated from
44 
Reason: update
Updated on 10/07/2019 10:58:05 AM
Updated from
 
Reason: This is the actual number of participants to date.
Updated on 11/09/2018 4:38:29 PM
Updated from
 
Reason: Actual number of participants randomised to this study before recruitment had to be ceased.
Updated on 16/06/2021 7:37:01 AM
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 8815 0
Austin Health - Heidelberg Repatriation Hospital - Heidelberg West
Inserted
 
Reason: New site
Updated on 16/08/2017 1:29:31 PM
Recruitment postcode(s) [1] 16939 0
3081 - Heidelberg West
Inserted
 
Reason: New site
Updated on 16/08/2017 1:29:31 PM

Funding & Sponsors
Funding source category [1] 289401 0
Self funded/Unfunded
Name [1] 289401 0
Country [1] 289401 0
Primary sponsor type
University
Name
University of Melbourne
Address
Dept. of Medicine
146 Studley Road
Heidelberg 3082
Victoria
Country
Australia
Secondary sponsor category [1] 288083 0
Hospital
Name [1] 288083 0
Austin Health
Address [1] 288083 0
146 Studley Road Heidelberg 3082 Victoria
Country [1] 288083 0
Australia

Ethics approval
Ethics application status
Approved
Updated from
Not yet submitted  
Reason: Approved
Updated on 16/08/2017 1:29:31 PM
Ethics committee name [1] 291161 0
Austin Health
Ethics committee address [1] 291161 0
Ethics committee country [1] 291161 0
Australia
Date submitted for ethics approval [1] 291161 0
01/08/2014
Approval date [1] 291161 0
08/08/2017
Updated from
 
Reason:
Updated on 16/08/2017 1:29:31 PM
Ethics approval number [1] 291161 0
HREC/16/Austin/98
Updated from
 
Reason: Approval ID
Updated on 16/08/2017 1:29:31 PM

Summary
Brief summary
Updated from
 
Reason:
Updated on 16/08/2017 1:29:31 PM
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 49154 0
A/Prof Mathis Grossmann
Address 49154 0
Department of Medicine Austin Health The University of Melbourne 145 Studley Road, Heidelberg, VIC 3084, Australia
Country 49154 0
Australia
Phone 49154 0
+61394965000
Fax 49154 0
Email 49154 0
[email protected]
Contact person for public queries
Name 49155 0
Nicholas Russell
Updated from
Mathis Grossmann  

Updated on 16/08/2017 1:29:31 PM
Address 49155 0
Department of Medicine Austin Health The University of Melbourne 145 Studley Road, Heidelberg, VIC 3084, Australia
Country 49155 0
Australia
Phone 49155 0
+61394965000
Fax 49155 0
Email 49155 0
[email protected]
Updated from
[email protected]  

Updated on 16/08/2017 1:29:31 PM
Contact person for scientific queries
Name 49156 0
Nicholas Russell
Updated from
Mathis Grossmann  

Updated on 16/08/2017 1:29:31 PM
Address 49156 0
Department of Medicine Austin Health The University of Melbourne 145 Studley Road, Heidelberg, VIC 3084, Australia
Country 49156 0
Australia
Phone 49156 0
+61394965000
Fax 49156 0
Email 49156 0
[email protected]
Updated from
[email protected]  

Updated on 16/08/2017 1:29:31 PM

Data sharing statement
Will the study consider sharing individual participant data?
Yes
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Will there be any conditions when requesting access to individual participant data?
Persons/groups eligible to request access:
• Researchers who provide a methodologically sound proposal

Conditions for requesting access:
• -

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What individual participant data might be shared?
• De-identified individual participant data underlying published results.
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What types of analyses could be done with individual participant data?
• Any purpose
Show/Hide History


When can requests for individual participant data be made (start and end dates)?
From:
From publication of results for a period of 5 years

To:
-

Show/Hide History


Where can requests to access individual participant data be made, or data be obtained directly?
• Access subject to approvals by Principal Investigator ([email protected])
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Are there extra considerations when requesting access to individual participant data?
No
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What supporting documents are/will be available?

No Supporting Documents Provided
Results publications and other study-related documents

No Study Results Provided